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OP RSH PRO00042503 GUAN DS7300-202 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  SCREENING

Screening (-28 to 0)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	28-day screening period can be extended to 42 days for subjects with an initial B7 homologue 3 (B7-H3) NE result who will be undergoing retesting and/or will provide a new biopsy.
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Informed Consent Main ICF. Obtain prior to performing any study procedures.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Eligibility Assessment. Review all inclusion/exclusion criteria to determine eligibility.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Medical History/Demographics.  Record all relevant medical history, including the disease under study.
Demographics includes age, sex, race, and ethnicity (as allowed per local regulations).
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as
clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Measure before infusion
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	ECOG PS. Use the same test for a subject throughout the study.
Performed at SCR, EOT, and as clinically indicated. If the test is performed as part of standard of care
within 14 days of signed consent, results could be considered to assess the subject's eligibility.
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Ophthalmologic Assessments.  Includes visual acuity testing, slit lamp examination,
tonometry, and fundoscopy. Performed at SCR, EOT, and as clinically indicated
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure or intervention or any SAE should be reported after the subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Height: only at Screening
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies. Includes medications, prophylactic therapies (including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR. Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by
the investigator must be reported.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Local measurement. ECGs will be taken while the subject is in a supine/ semirecumbent position for 5 minutes or more. ECGs will be taken in triplicate at SCR only and single ECG thereafter. Single ECG will be performed prior to the dosing every 4 cycles, EOT, and as clinically indicated during the Treatment Period. If ECG is abnormal, follow the institutional guidelines. Single ECG will be performed unless a clinically significant abnormality is noted by the investigator, in which case they should be done in
triplicate.
1. Every 4 cycles predose starting at C5D1 (eg, C5D1,C9D1, etc), EOT, and as clinically indicated during the Treatment Period.
			Imaging
◉	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o ECHO or MUGA 
o Use the same test for a subject throughout the study.
Performed at SCR, EOT, and as clinically indicated. If the test is performed as part of standard of care
within 14 days of signed consent, results could be considered to assess the subject's eligibility.
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	o MUGA or ECHO 
o Use the same test for a subject throughout the study.
Performed at SCR, EOT, and as clinically indicated. If the test is performed as part of standard of care.Within 14 days of signed consent, results could be considered to assess the subject's eligibility.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Coagulation. Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	Local laboratory testing. If required by local regulations or by the IRB/IEC.
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	Local laboratory testing.Perform hepatitis B and C screening. If hepatitis serology is performed within 14 days before signed consent, results could be considered to assess the subject's eligibility.
		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --	Comments:	Local laboratory testing.Perform hepatitis B and C screening. If hepatitis serology is performed within 14 days before signed consent, results could be considered to assess the subject's eligibility.
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.Perform hepatitis B and C screening. If hepatitis serology is performed within 14 days before signed consent, results could be considered to assess the subject's eligibility.
		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.Perform hepatitis B and C screening. If hepatitis serology is performed within 14 days before signed consent, results could be considered to assess the subject's eligibility.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tumor Tissue Sample. Newly obtained pretreatment or archival tumor tissue of sufficient quantity and of adequate tumor tissue content (as defined in the Laboratory Manual) is required for all subjects and to be provided as either of the following:
 If medically feasible, a newly obtained pretreatment tumor biopsy from at least 1 lesion not previously irradiated and amenable to core biopsy
 If the samples provided are not adequate, additional samples will be required.
OR
  If it is not medically feasible to collect the pretreatment tumor biopsy, archival tumor tissue from
a lesion not previously irradiated and collected from a biopsy performed within 6 months of consent and performed after treatment with the most recent anticancer treatment regimen is acceptable. Refer to the Study Laboratory Manual for the sample
preparation, storage, and shipment procedures.