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OP RSH PRO00043760 3082-CL-0301 ABDELRAHIM SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00043760 3082-CL-0301 ABDELRAHIM, HER2 BLOCKADE

Screening ( -45 to -1 Day)	Repeat 1 time	Cycle length: 45 days	45 Days Prior to Registration	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	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[AR1] :  3082-CL-0301_Abdelrahim
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  ASP3082 Treatment: Refer to Section 6.5.1
Protocol Access Hyperlink[AR1] :  3082-CL-0301_Abdelrahim
			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Nursing Communication : The screening period will last 45 days from ICF signing. Rescreening outside of the 45-day window under a new participant number may be allowed one time per participant, as needed, following discussion with the medical monitor. If rescreening occurs, KRAS G12D mutation status does not need to be retested. Participants will be randomized in a 1:1 ratio to either the ASP3082 arm or the placebo arm [Table 10] after the screening period and after signing the ICF.
			Nursing Orders
  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Chemotherapy (mFOLFIRINOX or NALIRIFOX). Up to 2 doses (i.e., 28 days; 1 cycle) of mFOLFIRINOX/NALIRIFOX are permitted during the screening period, after the participant signs the ICF.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Informed consent
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Verify Inclusion/Exclusion
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Medical History/Disease History/Demographics
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Interactive Response technology ( IRT) Transaction for Participant Status. Enrollment will be conducted via the IRT system after confirmation of eligibility and prior to dosing. Enrollment may occur up to 1 calendar day prior to the C1D1 visit.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Full Physical Examination
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs (including temperature, pulse rate, respiratory rate, blood pressure and SpO2 [with SpO2 assessments only applicable if clinically indicated during the mFOLFIRINOX/NALIRIFOX study treatment period, at the investigator's discretion]) and the brief physical examination, as applicable, are required 1) predose (within 15 minutes prior to the start of dosing) and 2) at the onset of drug-related IRR events during ASP3082 infusion.
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Ascites Evaluation
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Prior/Concomitant Medications. All medications, including concomitant treatments and non-medication therapy administered from screening through the safety follow-up visit must be recorded. Only subsequent anticancer treatment needs to be recorded during the survival follow-up period. Concomitant medications and treatments associated with AEs that are ongoing with ASP3082 at EOT must be recorded until completion of follow-up of the associated AE. All anticancer treatment should be collected from screening through the post-treatment follow-up period.
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment. AEs and SAEs will be collected from the time the participant signs the ICF through the time of documentation as a screen failure, through the safety follow-up period (as defined
in [Section 8.1.1]) or until the start of subsequent anticancer treatment, whichever comes first.
			Imaging
☑	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	CT or MRI scans are preferred for this study, and the same technique used at screening should be utilized throughout the study to ensure comparability. Imaging should include chest, abdomen and pelvis, as well as any other anatomical region appropriate for the participant's disease. Confirmatory scans for CR or PR should be done >= 4 weeks after the date of the scan during which CR or PR was first observed. Additional information will be provided in the imaging manual(s).
An ad-hoc scan may be taken at the discretion of the investigator prior to randomization. If multiple scans are conducted prior to randomization, the most recent scan should be used as the baseline. A baseline tumor scan is required within 28 days prior to randomization. During the screening period, imaging scans performed prior to informed consent as standard of care are acceptable as screening scans if done within 28 days prior to randomization. For participants who receive up to 2 doses (1 cycle) of mFOLFIRINOX or NALIRIFOX during the screening period, eligible scan(s) must be performed prior to mFOLFIRINOX or NALIRIFOX administration. Refer to [Section 7.2.1] for additional details.
		☑	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Imaging
		☐	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Imaging
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Imaging
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Imaging
		☑	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☑	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☑	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE AB, QUANTITATIVE	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Qualitative HCV RNA (if HCV-Positive)
			Labs
☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	All clinical laboratory (chemistry, hematology, thyroid function, coagulation) and urinalysis testing will be performed centrally. Local clinical laboratory and urinalysis test results may be used for safety assessments and clinical decision-making per local standard of care; however, samples must also be drawn and sent to the central laboratory, per protocol,unless otherwise approved by the sponsor. Refer to [Section 7.3.1] for detailed requirements related to timing, collection, reporting, etc.
Thyroid/parathyroid function will be assessed at screening and EOT. Additional thyroid/parathyroid function testing may be performed during the study treatment period if clinically indicated, at the investigator's discretion.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T3, FREE	Interval: --	Occurrences: --		☑	PARATHYROID HORMONE (PTH) AND CALCIUM	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Urine or serum pregnancy test and medical evaluation by interview will be performed locally in WOCBP. Testing at treatment visits must occur prior to administration of any study intervention (e.g., ASP3082/placebo, mFOLFIRINOX or NALIRIFOX). WOCBP must have a negative, highly sensitive serum pregnancy test within 7 days of the first administration of ASP3082/placebo and must agree to undergo further pregnancy tests (urine or serum) once every study cycle and at the EOT and safety follow-up visits.
Pregnancy testing will be performed locally, and all tests must be entered into the clinical database from the screening period through the safety follow-up period.
· C1D1: May be performed 1 day prior to this visit. The C1D1 assessment should be performed separately from the screening assessment, on a different date.
· Day 1 visit(s) for cycle >= 2: May be performed up to 72 hours prior to the scheduled day 1 time point.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Urine or serum pregnancy test and medical evaluation by interview will be performed locally in WOCBP. Testing at treatment visits must occur prior to administration of any study intervention (e.g., ASP3082/placebo, mFOLFIRINOX or NALIRIFOX). WOCBP must have a negative, highly sensitive serum pregnancy test within 7 days of the first administration of ASP3082/placebo and must agree to undergo further pregnancy tests (urine or serum) once every study cycle and at the EOT and safety follow-up visits. Pregnancy testing will be performed locally, and all tests must be entered into the clinical database from the screening period through the safety follow-up period.
· C1D1: May be performed 1 day prior to this visit. The C1D1 assessment should be performed separately from the screening assessment, on a different date.
· Day 1 visit(s) for cycle >= 2: May be performed up to 72 hours prior to the scheduled day 1 time point.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	All clinical laboratory (chemistry, hematology, thyroid function, coagulation) and urinalysis testing will be performed centrally. Local clinical laboratory and urinalysis test results may be used for safety assessments and clinical decision-making per local standard of care; however, samples must also be drawn and sent to the central laboratory, per protocol, unless otherwise approved by the sponsor. Refer to [Section 7.3.1] for detailed requirements related to timing, collection, reporting, etc.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	UGT1A1 Polymorphism
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	KRAS G12D Status. Refer to [Section 7.7.2.1] for detailed requirements regarding this tumor tissue sample for eligibility.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tumor Tissue Specimen. All participants, regardless of whether KRAS G12D mutation status has been determined by local or central testing, must submit a baseline tumor tissue specimen for the study during screening. Refer to [Section 7.7.2.2] for additional details.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Blood Specimen. For all participants, a blood sample for diagnostic development (and exploratory research, if applicable) must be submitted at the same time as tumor tissue submission for KRAS G12D mutation status testing [Footnote 15] and [Footnote 16]. Refer to [Section 7.7.2.2] for additional details.