Protocol Index	

If this file opens in Compatibility Mode using Microsoft Word, convert to the latest document format to avoid potential formatting issues.	

RESEARCH PRO00022270 / ABDELRAHIM / ASTELLAS ISN 8951-CL-5201 ARM 1	

Types:      Research Oncology Treatment
Synonyms:  PRO22270, 22270, 8951 CL 5201, ZOLBETUXIMAB , IMAB362

Screening	Repeat 1 time	Cycle length: 45 days	-45 to -1 days	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --				-28 to -1 days	Perform every 1 day x1		Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	o  If CT scan with contrast is medically not feasible, magnetic resonance imaging may be used for imaging. 
o Bone scans (or focal X-ray) should be performed if metastatic disease in bone is suspected.
				-14 to -1 days	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For childbearing potential only
					
Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For childbearing potential only
		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
Following the first dose of zolbetuximab on C1D1, the subject must be observed for 2 hours post zolbetuximab infusion. The post-infusion observation period can be conducted during the Nab-P + GEM administration. If AEs are observed during this time, subsequent zolbetuximab infusion times should be extended and subjects should continue to be observed for 2 hours post zolbetuximab infusion.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 8	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
◯	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◉	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous		Start: S					Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For childbearing potential only
		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 8	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
◯	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◉	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous		Start: S					Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	o  If CT scan with contrast is medically not feasible, magnetic resonance imaging may be used for imaging. 
o Bone scans (or focal X-ray) should be performed if metastatic disease in bone is suspected.
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For childbearing potential only
		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 8	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
◯	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◉	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous		Start: S					Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For childbearing potential only
		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 8	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
◯	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◉	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous		Start: S					Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	o  If CT scan with contrast is medically not feasible, magnetic resonance imaging may be used for imaging. 
o Bone scans (or focal X-ray) should be performed if metastatic disease in bone is suspected.
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For childbearing potential only
		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 8	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
◯	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◉	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous		Start: S					Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For childbearing potential only
		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 8	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
◯	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◉	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous		Start: S					Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	o  If CT scan with contrast is medically not feasible, magnetic resonance imaging may be used for imaging. 
o Bone scans (or focal X-ray) should be performed if metastatic disease in bone is suspected.
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For childbearing potential only
		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 8	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
◯	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◉	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous		Start: S					Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For childbearing potential only
		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 8	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
◯	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◉	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous		Start: S					Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 9	Repeat 1 time	Cycle length: 22 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	o  If CT scan with contrast is medically not feasible, magnetic resonance imaging may be used for imaging. 
o Bone scans (or focal X-ray) should be performed if metastatic disease in bone is suspected.
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For childbearing potential only
		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 8	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
◯	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◉	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous		Start: S					Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If clinically indicated and/or per local requirements
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Zolbetuximab will be administered as a 2-hour intravenous infusion once every 2 weeks (Q2W) starting on C1D1. Zolbetuximab should be administered prior to Nab-P + GEM. The infusion of zolbetuximab should be completed in less than 6 hours from the start of infusion.
o The Safety Lead-in Phase will begin with Dose Level 1. Based on the result of the Safety Lead-in Phase, either Dose Level 1 or Dose Level -1 will be selected for the Randomization Phase. 
o Dose Level 1: 1000 mg/m² loading dose on C1D1 followed by subsequent doses of 600 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
o Dose Level -1: 800 mg/m² loading dose on C1D1 followed by subsequent doses of 400 mg/m² zolbetuximab Q2W on days 1 and 15 of each 28-day cycle. 
There will be no dose reduction below 400 mg/m2. Subjects will be administered zolbetuximab as a 2-hour intravenous infusion.
		  	INV-Zolbetuximab (8951-CL-5201/Pro00022270/Abdelrahim) in sodium chloride 0.9% infusion	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB 20 MG/ML INTRAVENOUS SOLN (8951-CL-5201/PRO00022270/ABDELRAHIM)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Post-infusion Observation Period 
If the subject does not develop any AEs, the subject should be observed for 1-hour post-infusion for their subsequent zolbetuximab infusions. The subject should be instructed to notify site personnel if they develop any AEs during this observation time period. In the event of Grade 3 or 4 infusion related reactions (IRRs) post zolbetuximab infusion, samples for cytokine/chemokine and tryptase should be collected
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Study Treatment Discontinuation Visit or End of Study Treatment (+7 days)	Repeat 1 time	Cycle length: 8 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	The Study Treatment Discontinuation Visit will take place ? 7 days following the last dose of study drug or the decision by the investigator to discontinue study treatment (zolbetuximab and/or Nab-P + GEM). If zolbetuximab and/or Nab-P + GEM (all components) are discontinued on a different day, subjects will have separate Study Treatment Discontinuation Visit following each treatment's discontinuation.
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	IF childbearing potential
		  	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
					
30-Day Safety Follow-up Visit (+7 days)	Repeat 1 time	Cycle length: 60 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	A 30-day Safety Follow-up Visit should occur 30 days (+7 days) from last dose of zolbetuximab and will include the assessments as shown the in the Schedule of Assessments above. A 30-day Safety Follow-up Visit should occur 30 days after the last dose of Nab-P + GEM (all components) and may be conducted by phone if the subject is unable to visit the site and will require contact for SAE/AE collection only.
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG
		  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	IF childbearing potential
		  	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	If clinically indicated
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If clinically indicated
					
90-Day Safety Follow-up Visit (+7 days)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	A 90-day Safety Follow-up Visit should occur 90 days (±7 days) for safety after the last dose of zolbetuximab and will include the assessments as shown the in the Schedule of Assessments above. A 90-day Safety Follow-up Visit should occur 90 days after the last dose of Nab-P + GEM and may be conducted by phone if the subject is unable to visit the site and will require contact for SAE/AE collection only.
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG