Conditions: Metastatic Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 77
Healthy volunteers: no

Brief summary:
The goals of this clinical study are to learn more about the safety, tolerability and effectiveness of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).

The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).

Detailed description:

Arms:
arm 1: Participants will receive magrolimab + bevacizumab + FOLFIRI as mentioned below:

* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle. arm 2: Participants will receive magrolimab + bevacizumab + FOLFIRI as mentioned below:

* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle. arm 3: Participants will receive bevacizumab + FOLFIRI as mentioned below:

* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.

Interventions: intervention 1: Magrolimab intervention 2: Bevacizumab intervention 3: Irinotecan intervention 4: Fluorouracil intervention 5: Leucovorin
Intervention descriptions: intervention 1: Administered intravenous infusion intervention 2: Administered intravenous infusion intervention 3: Administered intravenous infusion intervention 4: Administered intravenous infusion intervention 5: Administered intravenous infusion

Protocol document:
Prot_000.pdf: 
CLINICAL STUDY PROTOCOL
Study Title:
A Phase 2, Randomized, Open-Label Study Evaluating the Safety 
and Efficacy of Magrolimab in Combination With Bevacizumab 
and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously 
Treated Advanced Inoperable Metastatic Colorectal Cancer 
(mCRC)
Short Title:
Study of Magrolimab Given Together With FOLFIRI/BEV in 
Patients With Previously Treated Advanced Inoperable Metastatic 
Colorectal Cancer (mCRC)
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
USA
IND Number:
117687
EU CT Number:
2022-500177-13-00
ClinicalTrials.gov 
Identifier:
NCT05330429
Indication:
Metastatic Colorectal Cancer (mCRC)
Protocol ID:
GS-US-587-6156
Contact Information:
The medical monitor name and contact information will be 
provided on the Key Study Team Contact List.
Protocol Version/Date:
Amendment 5
31 October 2023
Amendment History
Original:
28 September 2021
Amendment 1:
27 January 2022
Amendment 2:
10 March 2022
Amendment 2.1-CTIS:
12 July 2022
Amendment 3:
25 October 2022
Amendment 3.1-CTIS
26 October 2022
Amendment 4
21 June 2023
Amendment 5
31 October 2023
High-level summaries of the histories of amendments are provided 
in Appendix 13.
GILEAU 


Country-specific 
Requirements:
Country-specific requirements, as applicable, are listed in 
Appendix 12.
This study will be conducted under United States Food and Drug Administration investigational 
new drug application regulations (21 Code of Federal Regulations Part 312); however, sites 
located in the European Economic Area, the United Kingdom, and Switzerland are not included 
under the investigational new drug application and are considered noninvestigational new drug 
application sites.
CONFIDENTIALITY STATEMENT
The information contained in this document, particularly unpublished data, is the property or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable 
institutional review board or independent ethics committee. The information is only to be used 
by you in connection with authorized clinical studies of the investigational drug described in 
the protocol. You will not disclose any of the information to others without written 
authorization from Gilead Sciences, Inc., except to the extent necessary to obtain informed 
consent from those persons to whom the drug may be administered.


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TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................3
LIST OF IN-TEXT TABLES .........................................................................................................................................7
LIST OF IN-TEXT FIGURES........................................................................................................................................7
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ...................................................................................8
PROTOCOL SYNOPSIS..............................................................................................................................................12
STUDY SCHEMA........................................................................................................................................................18
STUDY PROCEDURES TABLES ..............................................................................................................................19
1.
INTRODUCTION................................................................................................................................................25
1.1.
Background..............................................................................................................................................25
1.2.
Information About Magrolimab ..............................................................................................................26
1.2.1.
General Information ..............................................................................................................27
1.3.
Information About Bevacizumab, FOLFIRI, and Study Auxiliary Medicinal Products ........................27
1.3.1.
Role of Chemotherapy in Metastatic Colorectal Cancer.......................................................27
1.3.2.
Bevacizumab in Metastatic Colorectal Cancer......................................................................27
1.3.3.
Information on Study Auxiliary Medicinal Products/Noninvestigational 
Medicinal Products................................................................................................................28
1.4.
Rationale for This Study..........................................................................................................................28
1.4.1.
Retreatment/Rechallenge.......................................................................................................28
1.4.2.
Therapy Sequencing ..............................................................................................................29
1.4.3.
Inclusion of Bevacizumab- or anti-EGFR-Experienced Patients..........................................29
1.4.4.
KRAS All-Comers.................................................................................................................29
1.4.5.
Combination With Chemotherapy.........................................................................................29
1.4.6.
FOLFIRI as Chemotherapy Backbone ..................................................................................29
1.4.7.
Combination With Bevacizumab ..........................................................................................32
1.4.8.
Randomization.......................................................................................................................32
1.5.
Rationale for Dose Selection of Magrolimab..........................................................................................33
1.6.
Risk/Benefit Assessment for the Study ...................................................................................................33
1.7.
Compliance..............................................................................................................................................34
2.
OBJECTIVES AND ENDPOINTS......................................................................................................................35
3.
STUDY DESIGN.................................................................................................................................................36
3.1.
Study Design Overview...........................................................................................................................36
3.1.1.
Safety Run-in Cohort.............................................................................................................36
3.1.2.
Randomized Cohort...............................................................................................................39
3.2.
Study Treatments.....................................................................................................................................40
3.3.
Duration of Treatment .............................................................................................................................40
3.4.
Discontinuation Criteria ..........................................................................................................................40
3.4.1.
Early Discontinuation From Study Treatment ......................................................................40
3.4.2.
Early Discontinuation From the Study..................................................................................41
3.5.
Definitions for Time of Primary Endpoint and End of Study .................................................................42
3.5.1.
Primary Endpoint...................................................................................................................42
3.5.2.
End of Study..........................................................................................................................42
3.6.
Poststudy Care.........................................................................................................................................42
3.7.
Source Data .............................................................................................................................................42
4.
PATIENT POPULATION ...................................................................................................................................43
4.1.
Number of Patients and Patient Selection ...............................................................................................43


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4.1.1.
Patient Replacement ..............................................................................................................43
4.2.
Inclusion Criteria.....................................................................................................................................43
4.3.
Exclusion Criteria....................................................................................................................................44
5.
STUDY DRUGS ..................................................................................................................................................47
5.1.
Randomization, Blinding, and Treatment Codes Access ........................................................................47
5.1.1.
Randomization.......................................................................................................................47
5.1.2.
Blinding .................................................................................................................................47
5.2.
Description and Handling of Magrolimab...............................................................................................47
5.2.1.
Formulation ...........................................................................................................................47
5.2.2.
Packaging and Labeling ........................................................................................................47
5.2.3.
Storage and Handling ............................................................................................................47
5.3.
Description and Handling of Bevacizumab.............................................................................................48
5.3.1.
Formulation ...........................................................................................................................48
5.3.2.
Packaging and Labeling ........................................................................................................48
5.3.3.
Storage and Handling ............................................................................................................48
5.4.
Description and Handling of FOLFIRI ...................................................................................................48
5.4.1.
Formulation ...........................................................................................................................48
5.4.2.
Packaging and Labeling ........................................................................................................48
5.4.3.
Storage and Handling ............................................................................................................48
5.5.
Dosage and Administration of Magrolimab............................................................................................49
5.5.1.
Treatment Delay and Repriming/Re-escalation for Magrolimab..........................................51
5.5.2.
Dose Modification and Delays for Magrolimab....................................................................51
5.5.3.
Premedication and Prophylaxis for Magrolimab...................................................................53
5.6.
Dosage and Administration of Bevacizumab and FOLFIRI ...................................................................53
5.7.
Prior and Concomitant Medications........................................................................................................54
5.7.1.
Permitted Concomitant Medications for All Cohorts............................................................54
5.7.2.
Coronavirus Disease 2019 (COVID-19) Vaccine .................................................................54
5.7.3.
Prohibited Concomitant Medications....................................................................................54
5.8.
Accountability for Study Drug(s)............................................................................................................54
5.8.1.
Study Drug Return or Disposal .............................................................................................55
6.
STUDY PROCEDURES......................................................................................................................................56
6.1.
Informed Consent ....................................................................................................................................56
6.1.1.
Informed Consent for Optional Research..............................................................................56
6.2.
Prescreening, Screening, Patient Enrollment, and Treatment Assignment.............................................56
6.2.1.
Prescreening ..........................................................................................................................57
6.3.
Instructions for Study Procedures ...........................................................................................................57
6.3.1.
Adverse Events......................................................................................................................57
6.3.2.
Type and Screen and Direct Antiglobulin Test .....................................................................57
6.3.3.
Concomitant Medications......................................................................................................57
6.3.4.
Pregnancy Test ......................................................................................................................57
6.3.5.
Physical Examination ............................................................................................................57
6.3.6.
Vital Signs, Weight, and Height............................................................................................58
6.3.7.
Electrocardiograms................................................................................................................58
6.3.8.
Performance Status................................................................................................................58
6.3.9.
Clinical Laboratory Assessments ..........................................................................................58
6.3.10.
Efficacy Assessments ............................................................................................................60
6.3.11.
Pharmacokinetics...................................................................................................................60
6.3.12.
Immunogenicity.....................................................................................................................60
6.3.13.
Biomarker Testing.................................................................................................................60
6.3.14.
Patient-Reported Outcomes...................................................................................................62
6.4.
Assessments for Early Discontinuation From Study Treatment or From the Study ...............................64
6.4.1.
Assessments for Early Discontinuation From Study Treatment ...........................................64


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6.5.
Poststudy Care.........................................................................................................................................64
6.6.
Sample Storage........................................................................................................................................64
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT................................................................................65
7.1.
Definitions of Adverse Events and Serious Adverse Events...................................................................65
7.1.1.
Adverse Events......................................................................................................................65
7.1.2.
Serious Adverse Events.........................................................................................................65
7.1.3.
Study Drugs and Gilead Concomitant Medications Special Situations 
Reports...................................................................................................................................67
7.2.
Assessment of Adverse Events and Serious Adverse Events..................................................................67
7.2.1.
Assessment of Causality for Study Drugs/NIMPs and Procedures.......................................68
7.2.2.
Assessment of Severity..........................................................................................................68
7.3.
Investigator Reporting Requirements and Instructions ...........................................................................68
7.3.1.
Requirements for Collection Before Study Drug Initiation ..................................................68
7.3.2.
Adverse Events......................................................................................................................68
7.3.3.
Serious Adverse Events.........................................................................................................69
7.3.4.
Study Drug Special Situations Reports .................................................................................69
7.3.5.
Concomitant Medications Reports ........................................................................................69
7.4.
Reporting Process for Serious Adverse Events and Special Situations Reports.....................................70
7.4.1.
Serious Adverse Event Reporting Process ............................................................................70
7.4.2.
Special Situations Reporting Process ....................................................................................70
7.5.
Gilead Reporting Requirements ..............................................................................................................72
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events...........................................................................................................................72
7.7.
Abnormal Liver Function Tests...............................................................................................................72
7.8.
Toxicity Management..............................................................................................................................73
7.8.1.
Magrolimab ...........................................................................................................................73
7.8.2.
Bevacizumab, 5-fluorouracil, Irinotecan, and Leucovorin/Levoleucovorin .........................79
8.
STATISTICAL CONSIDERATIONS.................................................................................................................80
8.1.
Analysis Objectives and Endpoints.........................................................................................................80
8.2.
Planned Analyses.....................................................................................................................................80
8.2.1.
Dose Determination Analysis................................................................................................80
8.2.2.
Primary Analysis ...................................................................................................................80
8.2.3.
Final Analysis........................................................................................................................80
8.3.
Analysis Conventions..............................................................................................................................80
8.3.1.
Analysis Sets .........................................................................................................................80
8.3.2.
Data Handling Conventions ..................................................................................................82
8.4.
Demographic and Baseline Characteristics Analysis..............................................................................82
8.5.
Efficacy Analysis.....................................................................................................................................82
8.5.1.
Primary Efficacy Endpoint Analysis.....................................................................................82
8.5.2.
Secondary Efficacy Endpoint Analyses ................................................................................83
8.6.
Safety Analysis........................................................................................................................................83
8.6.1.
Primary Safety Endpoint Analysis ........................................................................................83
8.6.2.
Other Safety Analysis............................................................................................................83
8.6.3.
Extent of Exposure ................................................................................................................83
8.6.4.
Adverse Events......................................................................................................................83
8.6.5.
Laboratory Evaluations .........................................................................................................84
8.6.6.
Other Safety Evaluations.......................................................................................................84
8.7.
Pharmacokinetic Analysis .......................................................................................................................84
8.8.
Immunogenicity Analysis........................................................................................................................84
8.9.
Biomarker Analysis.................................................................................................................................84
8.10.
Analysis of Patient-Reported Outcome Data ..........................................................................................85
8.11.
Sample Size .............................................................................................................................................85


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8.12.
Gilead Data Review Committee..............................................................................................................85
9.
RESPONSIBILITIES...........................................................................................................................................86
9.1.
Investigator Responsibilities ...................................................................................................................86
9.1.1.
Good Clinical Practice...........................................................................................................86
9.1.2.
Financial Disclosure ..............................................................................................................86
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval................................................................................................................................86
9.1.4.
Informed Consent ..................................................................................................................86
9.1.5.
Confidentiality.......................................................................................................................87
9.1.6.
Study Files and Retention of Records ...................................................................................87
9.1.7.
Case Report Forms ................................................................................................................88
9.1.8.
Investigator Inspections.........................................................................................................89
9.1.9.
Protocol Compliance .............................................................................................................89
9.2.
Sponsor Responsibilities .........................................................................................................................89
9.2.1.
Protocol Modifications ..........................................................................................................89
9.2.2.
Study Reports and Publications.............................................................................................89
9.3.
Joint Investigator/Sponsor Responsibilities ............................................................................................90
9.3.1.
Payment Reporting ................................................................................................................90
9.3.2.
Access to Information for Monitoring...................................................................................90
9.3.3.
Access to Information for Auditing or Inspections ...............................................................90
9.3.4.
Study Discontinuation ...........................................................................................................90
10.
REFERENCES.....................................................................................................................................................91
11.
APPENDICES......................................................................................................................................................95
Appendix 1.
Investigator Signature Page.....................................................................................................96
Appendix 2.
Magrolimab Repriming Administration and Associated Assessment Schedule .....................97
Appendix 3.
Pandemic Risk Assessment and Mitigation Plan ....................................................................99
Appendix 4.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements..................................................................................................103
Appendix 5.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities ........................................................................................................................107
Appendix 6.
Eastern Cooperative Oncology Group (ECOG) Performance Status....................................108
Appendix 7.
Response Evaluation Criteria in Solid Tumors (RECIST V1.1)...........................................109
Appendix 8.
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire – Core Questionnaire (EORTC QLQ-C30)....................................................110
Appendix 9.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L).................................................112
Appendix 10.
FACT Colorectal Symptom Index (FCSI).............................................................................115
Appendix 11.
Authorization Status of Study Interventions .........................................................................116
Appendix 12.
Country-Specific Requirements ............................................................................................117
Appendix 13.
Amendment History ..............................................................................................................118
Appendix 14.
Sponsor Signature Page.........................................................................................................120


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LIST OF IN-TEXT TABLES
Table 1.
Study Procedures Table – Screening Assessments..................................................................19
Table 2.
Study Procedures Table – Treatment Period ...........................................................................20
Table 3.
Study Procedures Table – Posttreatment Assessments............................................................23
Table 4.
Stopping Boundaries Due to Toxicity (Phase 2 Randomized Cohort Arm A)........................39
Table 5.
Safety Run-in Cohort Dosing and Dose De-escalation Regimen............................................49
Table 6.
Randomized Cohort Dosing Regimen.....................................................................................50
Table 7.
Repriming Guidelines for Magrolimab ...................................................................................52
Table 8.
Magrolimab Dosing Guidance for Planned Surgical Procedures During the Study ...............53
Table 9.
Laboratory Analytesa ...............................................................................................................59
Table 10.
Local and Central Laboratory Assessment Requirements (Phase 2 Arm A Cycles 1 
and 2) .......................................................................................................................................74
Table 11.
Management of Pneumonitis...................................................................................................78
LIST OF IN-TEXT FIGURES
Figure 1.
Study Schema ..........................................................................................................................18
Figure 2.
Figure 3.
Figure 4. CCI


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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
5-FU
5-fluorouracil
ADA
antidrug antibody
AE
adverse event
ALT
alanine aminotransferase
AML
acute myeloid leukemia
ANC
absolute neutrophil count
aPTT
activated partial thromboplastin time
ASCO
American Society of Clinical Oncology
AST
aspartate aminotransferase
AxMP
auxiliary medicinal product
BRAF
v-raf murine sarcoma viral oncogene homolog B1
CBC
complete blood count
CD47
cluster of differentiation 47
CFR
Code of Federal Regulations
CI
confidence interval
CMV
cytomegalovirus
CNS
central nervous system
COVID-19
coronavirus disease 2019
CR
complete response
CRC
colorectal cancer
CSR
clinical study report
CT
computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
CTIS
Clinical trials information system
CTR
Clinical Trials Regulation
CYP
cytochrome P450 enzyme
DLT
dose-limiting toxicity
DNA
deoxyribonucleic acid
dMMR
mismatch repair deficiency
DOR
duration of response
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EDC
electronic data capture
EGFR
epidermal growth factor receptor
EORTC-QLQ-C30
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire - Core Questionnaire
ERBB
v-erb-b2 erythroblastic leukemia viral oncogene homolog
CCI
CCI-
-


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EQ-5D
EuroQol (5 dimensions)
EQ-5D-5L
5-level EuroQol 5 dimensions
EQ-VAS
EuroQol visual analogue scale
EU
European Union
EU CT
European Union Clinical Trials
FACT
Functional Assessment of Cancer Therapy
Fc
crystallizable fragment
FCSI
FACT Colorectal Symptom Index
FDA
Food and Drug Administration
FOLFIRI
5-fluorouracil, irinotecan, and leucovorin
FOLFOX
5-fluorouracil, oxaliplatin, and leucovorin
GCP
Good Clinical Practice
GDRC
Gilead Data Review Committee
Gilead
Gilead Sciences/Gilead Sciences, Inc.
PS
Patient Safety
Hb
hemoglobin
HER2
human epidermal growth factor receptor 2
HIV
human immunodeficiency virus
HR
hazard ratio
IB
investigator’s brochure
ICH
International Council for Harmonisation (of Technical Requirements for 
Pharmaceuticals for Human Use)
IEC
independent ethics committee
Ig
immunoglobulin
IND
investigational new drug
INR
international normalized ratio
IRB
institutional review board
IRR
infusion-related reaction
IRT
interactive response technology
ITT
intent to treat
IV
intravenous
KM
Kaplan-Meier
KRAS
Kirsten rat sarcoma
LV
leucovorin
MAPK
mitogen-activated protein kinase
MCH
mean corpuscular hemoglobin
MCHC
mean corpuscular hemoglobin concentration
mCRC
metastatic colorectal cancer
MCV
mean corpuscular volume
MDS
myelodysplastic syndrome
MedDRA
Medical Dictionary for Regulatory Activities
CCI-


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MID
minimum important difference
MNS
any of the blood groups M, N, and S comprising the MNS system
MOA
mechanism of action
MRI
magnetic resonance imaging
MSI-H
high microsatellite instability
MTD
maximum tolerated dose
NCCN
National Comprehensive Cancer Network
NCI
National Cancer Institute
NIMP
noninvestigational medicinal product
NRAS
neuroblastoma RAS viral oncogene homolog
ORR
objective response rate
OS
overall survival
PD
pharmacodynamic(s)
PD-1
programmed cell death-1
PFS
progression-free survival
PK
pharmacokinetic(s)
PR
partial remission
PRO
patient-reported outcome
Q2W
every 2 weeks
RANKL
receptor activator of nuclear factor kappa B ligand
RBC
red blood cell
RECIST
Response Evaluation Criteria in Solid Tumors
Rh
rhesus
RNA
ribonucleic acid
RO
receptor occupancy
ROW
rest of world
RP2D
recommended Phase 2 dose
SAE
serious adverse event
SAP
statistical analysis plan
SD
standard deviation
SIRPα
signal regulatory protein alpha
SOC
standard of care
SRT
Safety Review Team
SSR
special situation report
TRK
tropomyosin receptor kinase
ULN
upper limit of normal
US, USA
United States, United States of America
VBG
venous blood gas
VEGFR
vascular endothelial growth factor receptor
CCI
CCI
1111 
• 


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VEGF
vascular endothelial growth factor
w/v
weight-to-volume ratio
WBC
white blood cell


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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Study Title: A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy 
of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and 
FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
Short Title: Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With 
Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
Regulatory Agency Identifier Number(s):
IND Number: 117687
EU CT Number: 2022-500177-13-00
ClinicalTrials.gov Identifier: NCT05330429
Study Centers Planned:
Approximately 45 centers worldwide
Objectives and Endpoints: 
Primary Objectives
Primary Endpoints
Safety Run-in Cohort:
•
To evaluate the safety, tolerability, and 
recommended Phase 2 dose (RP2D) of 
magrolimab in combination with bevacizumab 
and FOLFIRI (5-fluorouracil [5-FU], irinotecan, 
and leucovorin [LV]) in previously treated 
patients with advanced inoperable metastatic 
colorectal cancer (mCRC)
Randomized Cohort:
•
To evaluate the efficacy of magrolimab in 
combination with bevacizumab and FOLFIRI in 
mCRC as determined by progression-free 
survival (PFS) by investigator assessment
Safety Run-in Cohort:
•
Incidence of dose-limiting toxicities (DLTs), and 
adverse events (AEs) and laboratory 
abnormalities according to National Cancer 
Institute (NCI) Common Terminology Criteria 
for Adverse Events (CTCAE), Version 5.0 
Randomized Cohort:
•
PFS, defined as the time from the date of 
randomization until the earliest date of 
documented disease progression as determined 
by investigator assessment using Response 
Evaluation Criteria in Solid Tumors Version 1.1 
(RECIST V1.1), or death from any cause, 
whichever occurs first
Secondary Objectives
Secondary Endpoints
Randomized Cohort:
•
To evaluate objective response rate (ORR) by 
investigator assessment 
•
To evaluate additional measures of efficacy of 
magrolimab in combination with bevacizumab 
and FOLFIRI, including duration of response 
(DOR) and overall survival (OS)
Randomized Cohort:
•
Confirmed ORR, defined as the proportion of 
patients with complete response (CR) or partial 
response (PR) on 2 consecutive assessments, at 
least 28 days apart, as determined by investigator 
assessment using RECIST V1.1 


Magrolimab 
Protocol GS-US-587-6156 
Gilead Sciences, Inc. 
• 
To evaluate patient-repo1ted outcomes 
(PRO)/quality-of-life measures for the 
Randomized Coho1t in mCRC with magrolimab 
in combination with bevacizumab and FOLFIRI 
Safety Run-in and Randomized Coho1ts: 
• 
To evaluate the phannacokinetics (PK) and 
immunogenicity of magrolimab in combination 
with bevacizumab and FOLFIRI 
Explorato1·y Objectives 
Final 
Amendment 5 
• 
DOR, defined as time from first documentation 
of CR or PR to the earliest date of documented 
disease progression as detennined by investigator 
assessment, per RECIST Vl. l , or death from any 
cause, whichever occurs first 
• 
OS, defined as time from date of randomization 
to death from any cause 
• 
PRO assessments (European Organisation for 
Research and Treatment of Cancer Quality of 
Life Questionnaire - Core Questionnaire 
[EORTC-QLQ-C30], the 5-level EuroQol 5 
dimensions questionnaire [EQ-5D-5L]) scores, 
and Functional Assessment of Cancer Therapy 
[FACT] Colorectal Symptom Index [FCSI] 
Safety Run-in and Randomized Coho1ts: 
• 
Magrolimab concentration versus time and 
antidtug antibodies (ADA) to magrolimab 
Explorato1-y Endpoints 
I 
I 
Study Design: A schematic diagram of the study is provided in Figure 1. 
This is a Phase 2, randomized, open-label, multicenter study to evaluate magrolimab in 
combination with bevacizumab and FOLFIRI in previously treated patients with advanced 
inoperable mCRC 
who do not 
harbor BRAF V600E mutations or high microsatellite instability (MSI-H). 
This study will consist of the following 2 coho1ts: 
• 
Safety Run-in Cohort: magrolimab in combination with bevacizumab and FOLFIRI in 
previously treated patients with advanced inoperable mCRC 
After completion of the Safety Run-in Cohort, the Randomized Coho1t will be open to 
emollment. 
• 
Randomized Cohort: magrolimab in combination with bevacizumab and FOLFIRI 
(Experimental Alm A) versus bevacizumab and FOLFIRI (Control Alm B) in previously 
treated patients with advanced inoperable mCRC 
Safety Run-in Cohort: approximately 6 patients will be enrolled in the Safety Run-in Cohort 
at a staiting dose level. A DLT-assessment period of28 days will occur. 
Although no dose-dependent toxicities have been obse1ved with magrolimab, in order to 
prese1ve the efficacious doses of the combination pa1tner diugs, dose de-escalation will take 
place for magrolimab as follows: 
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• 
If 2 or less of 6 DLT-evaluable patients experience a DLT dming the first 28 days, 
enrollment into the Randomized Coho1t will begin at this dose level as the RP2D. 
• 
If more than 2 patients experience at least one DLT during the first 28 days, enrollment at 
the cunent dose level will immediately stop and dose de-escalation will occur. Up to 
6 other patients will then be enrolled and evaluated at a lower dose level in the same 
manner. 
-
Once the RP2D is determined, the sponsor will open the Randomized Coho1t . 
Approximately 6 patients will be enrolled in the Safety Run-in Coho1t. Additional patients 
may be added to the Safety Run-in Coho1t or enrolled in a dose de-escalation coho1t. 
Dose-Limiting Toxicity Assessment Period for the Safety Run-in Cohort: The 
DLT-assessment period will be the first 28 days and applies to the Safety Run-in Coho1t. 
Patients are considered evaluable for assessment of a DL T if either of the following criteria is 
met in the DLT-assessment period: 
• 
The patient experienced a DLT at any time after initiation of the first infusion of 
magrolimab. 
• 
The patient did not experience a DLT and completes at least 3 infusions of magrolimab 
and at least 2 doses ofbevacizumab and FOLFIRI in the Safety Run-in Cohort. 
If a patient experiences a DLT dming the DL T-assessment period, the patient will discontinue 
treatment. 
Patients who are not evaluable for DLT assessment in the Safety Run-in Coho1t will be replaced. 
Randomized Cohort: Once the Safety Run-in Coho1t is completed and the RP2D for 
magrolimab in combination with bevacizumab and FOLFIRI is detennined, the sponsor will 
open the Randomized Coho1t . In this open-label, randomized, 2-aim study, patients with 
mCRC will be randomized in a 2: 1 ratio to receive either magrolimab in combination with 
bevacizumab and FOLFIRI (Experimental Alm A) or bevacizumab and FOLFIRI (Control 
Alm B). The primaiy efficacy assessment will be investigator assessed PFS, with the primaiy 
analysis to occur after 85 PFS events. Stratification factors for randomization include the 
following: (1) Kirsten rat sarcoma (KRAS) mutation/unknown versus wild-type status, 
(2) geographic region (United States [US] versus European Union [EU]/rest of world [ROW]), 
(3) presence versus absence of liver metastases. 
Number of Patients Planned: 
Approximately 135 patients 
• 
Safety Run-in Cohort: approximately 6 to 18 patients. Additional patients could be 
enrolled in this coho1t or in dose de-escalation coho1ts. 
• 
Randomized Coho1t: approximately 117 patients in Alms A and B. 
Target Po ulation: Previously treated patients with advanced inoperable mCRC who have 
progressed 
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Duration of Treatment: All patients will continue study ti·eatment unless they meet study 
ti·eatment discontinuation criteria. Survival follow-up will be conducted via a phone call 
Duration of survival follow-up will be limited to 
Diagnosis and Main Eligibility Criteria: 
• 
Male or female, at least 18 years of age. 
• 
Histologically or cytologically confnmed adenocarcinoma originating in the colon or 
rectum (excluding appendiceal and anal canal cancers) who have progressed on or after 
1 prior systemic therapy in the setting where curative resection is not indicated. This 
therapy must have included chemotherapy based on 5-FU or capecitabine with oxaliplatin 
and either bevacizumab, or for patients with RAS wild-type and left-sided tumors, 
bevacizumab, cetuximab, or panitumumab. 
• 
Measurable disease (at least 1 measurable metastatic lesion by RECIST Vl .1 criteria, with 
lesion not located in a previous field of radiation). Previously inadiated lesions can be 
considered as measurable disease only if disease progression has been unequivocally 
documented at that site since radiation. 
• 
Patients must have an Eastern Cooperative Oncology Group (ECOG) perfo1mance status 
of O or 1. 
Study Procedures/Frequency: The schedule of study procedures are presented in Table 1, 
Table 2, and Table 3. 
Test Product, Dose, and Mode of Administration: 
• 
Magrolimab 1 mg/kg inti·avenous (IV) 
• 
Magrolimab 15 mg/kg IV 
• 
Magrolimab 20 mg/kg IV 
• 
Magrolimab 30 mg/kg IV 
In combination with bevacizumab: 
• 
Bevacizumab: 5 mg/kg eve1y 2 weeks 
In combination with FOLFIRI. An example is provided below: 
• 
Irinotecan 180 mg/m2 Day 1 
• 
L V 400 mg/m2 over 2 hours Day 1 
• 
5-FU 400 mg/m2 bolus Day 1, followed by 2400 mg/m2 over 46 hours, continuous infusion 
Reference Therapy, Dose, and Mode of Administration: 
In combination with bevacizumab: 
• 
Bevacizumab: 5 mg/kg eve1y 2 weeks 
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In combination with FOLFIRI. An example is provided below.
•
Irinotecan 180 mg/m2 Day 1
•
LV 400 mg/m2 over 2 hours Day 1
•
5-FU 400 mg/m2 bolus Day 1, followed by 2400 mg/m2 over 46 hours, continuous infusion
Statistical Methods:
Analysis Data Sets
The DLT-Evaluable Analysis Set for the Safety Run-in Cohort will include all patients who 
meet one of the following criteria in the DLT-evaluable period:
•
Patient experienced a DLT at any time after initiation of the first infusion of magrolimab
•
Patient did not experience a DLT and completes at least 3 infusions of magrolimab and at 
least 2 doses of bevacizumab and FOLFIRI in the Safety Run-in Cohort.
For the Safety Run-in Cohort, the modified Intent-to-Treat (ITT) and Safety Analysis Sets will 
include all patients who received at least 1 dose of any study drug.
For the Randomized Cohort, the ITT Analysis Set will include all randomized patients 
according to the treatment arm to which the patients are randomized, unless otherwise 
specified. The Safety Analysis Set will include all randomized patients who received at least 
1 dose of any study drug, with treatment assignments designated according to the actual 
treatment received.
The PK Analysis Set will include all patients who received any amount of magrolimab and 
have at least 1 measurable posttreatment serum concentration of magrolimab.
The Immunogenicity Analysis Set will include all patients who received any amount of 
magrolimab and had at least 1 evaluable ADA test result.
The Biomarker Analysis Set includes all patients who received any study drug and have at 
least 1 evaluable biomarker measurement available. This will be the primary analysis set for 
all biomarker data analyses.
Dose Determination Analysis
For the purposes of making the dose de-escalation decisions for the Safety Run-in Cohort, 
dose determination analyses of relevant safety data focusing on DLTs and overall safety 
profile will be conducted by a safety review team after all patients have completed the 
required DLT-assessment period. Safety assessments (eg, AEs, electrocardiogram, laboratory 
results) will be displayed to facilitate the dose de-escalation decisions.
Efficacy Analysis
For the Randomized Cohort, PFS by investigator assessment will be analyzed using 
Kaplan-Meier (KM) methods. Patients who did not have documented disease progression or 
death will be censored at the date of their last response assessment during the study with 
documentation of no disease progression. The KM estimate of the survival function will be 
computed, and the results will be presented using KM curves. The median will be provided 


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along with the corresponding 95% CI. A log-rank test stratified by the randomization factors 
will be used to compare treatment difference in PFS. A stratified Cox proportional hazard 
regression model will be used to estimate the hazard ratio (HR) and its 2-sided 95% CI.
Safety Analysis
Safety will be assessed via AEs, clinical laboratory tests, and concomitant medications in the 
Safety Analysis Set. Information regarding study drug administration, study drug compliance, 
and other safety variables will also be summarized.
Sample Size Calculation
For the Randomized Cohort Arm A and Control Arm B, using an unstratified log-rank test, a 
total of 85 PFS events provides 73% power at a 1-sided alpha of 0.15 to detect a HR of 0.69 
(assuming median PFS of ≥ 8.3 months compared with a control arm median PFS of 
5.7 months). Assuming an accrual period of 10 months, a minimum follow-up time of 
10 months, and a 5% annual drop-out rate, 117 total patients (78 patients in experimental arm 
and 39 patients in the control arm) would be required to obtain 85 PFS events.
Power calculations were performed using EAST 6.5.
This study will be conducted in accordance with the guidelines of Good Clinical Practice, 
including archiving of essential documents.


Magrolimab 
Protocol GS-US-587-6156 
Gilead Sciences, Inc. 
Figure 1. 
Previously-treated 
inoperable metastatic 
CRC patients who: 
• Progressed on or after 
one prior systemic 
therapy 
• Ineligible for 
checkpoint inhibitor 
therapy 
N= 135 
STUDY SCHEMA 
Study Schema 
Safety Run-in 
MagrolImab + 
H P V ,H 1/Ufll,Jb • H)l 1--IHJsl 
N = 6 lo 18'° 
Safety evaluation 
.----
--+ 
&RP2D 
--+
. 
Final 
Amendment5 
Randomized Phase 2 
Arm A Magrohmab (up to 30 mg/kg)+ 
Bevacizumab + FOi FIRI 
N =78 
Arm B: Bevacizu01ab + rOLFIRI 
N =39 
5-FU = 5-fluorouracil· CRC = colorectal cancer: FOLFIRI = 5-fluorouracil. irinotecan. and leucovorin;----
; RP2D = rec~
dose; 
a 
FOLFIRI: 111notecan 180 mg/m2, leucovorin 400 mg/m2, fluorotu·acil 400 mg/m2. 
b 
Additional patients may be enrolled in the safety nm-in or in dose de-escalation cohorts. 
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STUDY PROCEDURES TABLES 
Final 
Amendment5 
Table 1. 
Study Procedures Table - Screening Assessments 
a 
b 
C 
d 
e 
f 
g 
h 
Assessment 
Infonned consent3 
Demographics 
Medical and cancer history 
ECOG 
Vital signs, height, and weight 
Complete physical examination 
Urinalysish 
Tumor imagi.ngi 
Tumor biopsy 
Serious adverse events related to protocol-mandated procedmes 
Concomitant medications 
Reflex microscopic testing based on other abno1malities. 
CT/MRI will be performed per Section 6.3.10. 
see Section 6.2.1. 
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Day -30 to -1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
31 October 2023 


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Table 2.
Study Procedures Table – Treatment Period
Visit Window (Days)
Cycle Day 
ECOGb
Vital signs and weightc
Symptom-directed physical 
examinationd
Pregnancy testd, e
Hematologyd, f
Serum or plasma chemistryd, g
Tumor imagingh
Tumor biopsy
Adverse events
Concomitant medications
PRO assessment: EORTC-QLQ-C30, 
EQ-5D-5L, and 
FACT Colorectal Symptom Indexb,d 
(Randomized Cohort only)
CCI
CCI
CCI


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Visit Window (Days) 
Cycle Day 
Magrolimab, bevacizumab, and 
FOLFIRI dosingv 
Final 
Amendment5 
; CEA = carcinoembryonic antigen; CT = computed tomography; DNA = deoxyribonucleic acid; ECOG = Eastem Cooperative Oncology Group; 
EORTC-QLQ-C30 = Etu·opean Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnait·e; EQ-5D-SL = 5-level Etu·oQol 5 
ditnensions; FACT = Functional Assessment of Cancer Thera ; FOLFIRI = 5-fluorouracil, irinotecan, and leucovorin; IRT = interactive response technology; LDH = lactate 
ii
l dr enase; MRI = magnetic resonance ituaging; 
PK = harmacokinetic(s); PRO = patient-reported outcome;-
RECIST = Response Evaluation Criteria in So 1 Ttuuors; RNA = n onuc e1c ac1 ; 
Section 6.3 .9 for complete list of analytes to be tested. All laboratory assessments are to e teste at 
e central laboratory per protocol or laboratory manual, unless local 
laborato1 testin o has been s ecified. 
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Table 3. 
Study Procedures Table - Posttreatment Assessments 
Visit Window 
Urine or sernm pregnancy test" 
Hematologyd 
Sernm or plasma chemisn-ye 
Tumor imaging for response assessmenti 
ECOG 
Vital signs 
Symptom-directed physical examination 
Adverse eventsk 
Concomitant medications 
New anticancer therapy1 
Survival follow-up 
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EOTVisit 
Within .. 
Afte1· 
Last Dose 01· EOT 
Decision 
Safety Follow-up 
Visit/Call (Telephone)• 
-
After Last Dose 
Page 23 
Preprogression Visitb 
After Safety Follow-up 
Until Disease 
Progression 
Sm-vival Follow-up 
(Telephone) 
Every-
After Safety 
Follow-up 
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ADA = antidrng antibody; AE = adverse event; CT = computed tomography; DNA = deoxyribonucleic acid; ECOG = Eastem Cooperative Oncology Group; EOT = end of 
treatment; MRI = magnetic resonance imaging; RECIST = Response Evaluation Criteria in Solid Tumors; RNA = ribonucleic acid; SAE = serious adverse event 
a 
If the patient experiences a treatment-related AE or an SAE (regardless of attribution), the patient must be asked to come to the site. 
b 
TI1is will only apply for patients who stop study treatment in the absence of progression of disease per RECIST VI. I and will continue to have tumor iniaging. Details on the 
r 
k 
l 
m 
tumor imaoino schedule are rovided in footnote·. Pr ro ession visits will be com leted fa-st before roceedin to survival follow-u . 
Tumor llllllgrng at EOT VISlt not reqmre I pe1 01me w1 rn t 1e ast 30 ays or progressive 1sease per RECIST VI. I as een documented. CT/MRI will be pe1fonued per 
Section 6.3. I 0. For patients who st.
stud treatment in the absence of progression of disease per RECIST VI. I ( eg, experienced unexpected toxicity), scans should continue 
to be collected approxiniately eve1 
until disease progression or initiation of systemic antitumor therapy other than the study treatment, whichever is earlier. 
Repo1t all AEs through the safety fo ow-up visit/call, and any treatment-related SAEs thereafter. 
Collect new anticancer therapy data following the last dose of stud treatment until the end of survival follow-up. 
Smvival follow-up will be conducted via a phone call every 
. Duration of survival follow-up will be limited tollll, 
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1.
INTRODUCTION
1.1.
Background
Metastatic colorectal adenocarcinoma ranks as the second most lethal cancer and the third most 
prevalent malignant tumor worldwide. In 2018, 1.8 million new cases and 881,000 deaths were 
reported, which accounted for nearly 10% of new cancer cases and deaths worldwide {Bray 
2018}. The number of new cases is expected to increase to nearly 2.5 million in 2035 {Dekker 
2019}. In the United States (US), metastatic colorectal cancer (mCRC) is the second leading 
cause of cancer deaths {Siegel 2018}. In 2020, 148,000 new diagnoses and 53,200 deaths were 
reported, including 17,930 cases and 3,640 deaths in individuals younger than 50 years of age. 
The 5-year survival rate is approximately 15% {Surveillance Epidemiology and End Results 
(SEER) 2021}. Although screening strategies and new treatment modalities have started to 
reduce the overall CRC death rate, the development of advanced metastatic disease is still 
associated with poor long-term survival. Recent data has demonstrated a continued decline in 
incidence and mortality in patients at least 65 years of age but a converse increase among those 
less than 65 years of age. The etiology of this phenomenon has yet to be determined and 
differences in genetics may be a factor. 
Colorectal cancer is a heterogeneous disease complicated by the common occurrence of several 
molecular alterations comprising the epidermal growth factor receptor (EGFR) pathway, 
including mutations in Kirsten rat sarcoma (KRAS), neuroblastoma RAS viral oncogene 
homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B1 (BRAF [V600E]), and 
in the human epidermal growth factor receptor 2 (HER2) and MET receptors. Other molecular 
alterations include DNA damage repair mechanisms and rare kinase fusions. Moreover, tumor 
sidedness is associated with distinct clinical and biological characteristics. Right-sided CRC is 
more common in women, and associated with Lynch syndrome, mitogen-activated protein kinase 
(MAPK)-signaling, high microsatellite instability (MSI-H), deficiency of mismatch repair genes, 
CpG island methylation, and KRAS and BRAF mutations. Left-sided CRC is more common in 
men, and associated with familial adenomatous polyposis syndrome, wingless-related integration 
site (Wnt) and EGFR signaling, chromosomal instability, v-erb-b2 erythroblastic leukemia viral 
oncogene homolog 1 (ERBB1) and ERBB2 amplifications, APC, p53, and NRAS mutations. 
These alterations represent oncogenic drivers that may coexist in the same tumor with other 
primary and acquired alterations via a clonal selection process.
Advances have been made in the therapy of CRC in targeted subgroups with specific mutational 
profiles. However, resistance to these targeted agents as well as standard chemotherapies based 
on specific molecular alterations have confounded treatment. Increasingly, enhanced knowledge 
about tumor biology is driving therapeutic decision-making. Optimal combinations and 
sequencing of these agents is continuing to evolve. Known biologic drugs that are active against 
mCRC include agents targeting vascular endothelial growth factors (VEGFs) and their receptors 
(VEGFRs), EGFR, BRAF V600E, HER2, immunotherapy using immune checkpoint inhibitors, 
and tropomyosin receptor kinase (TRK) inhibitors. Biomarkers have been defined for patients 
who are candidates for agents targeting EGFR, HER2, TRK fusions, and for immunotherapy, but 
are not yet defined for other agents.


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Systemic chemotherapy in combination with anti-EGFR antibodies such as cetuximab and 
panitumumab have significantly improved prognosis in KRAS wild-type patients {Lee 2015}. In 
addition, patients with MSI-H have demonstrated impressive responses to checkpoint inhibitors 
such as the anti–programmed cell death-1 (PD-1) agent pembrolizumab {Le 2015, Overman 
2016}, but this represents only a subset of this tumor type (10% to 15% at diagnosis). On the 
other hand, certain subsets of patients such as those with KRAS mutations, which comprise over 
40% of CRCs {Vaughn 2011}, do not respond to anti-EGFR antibody therapies {Allegra 2009}. 
Patients with KRAS-mutant mCRC have a poorer prognosis while having limited available 
therapies. For the majority of patients who are ineligible or unable to derive benefit from novel 
targeted therapies or immunotherapies, standard of care (SOC) doublet or triplet chemotherapy 
based regimens that are associated with systemic toxicity, unsatisfying response rates, 
unpredictable innate and acquired resistance, as well as low tumor-specific selectivity are the 
only available treatment options. Therefore, significant and clinically relevant improvements in 
efficacy that advance the treatment landscape are still needed to address this high unmet medical 
need in patients with CRC. 
1.2.
Information About Magrolimab
CD47 is a key molecule mediating cancer cell evasion of innate immune surveillance. CD47 
expression is a well-characterized mechanism by which cancer cells, including cancer stem cells, 
overcome phagocytosis due to intrinsic expression of prophagocytic “eat me” signals {Jaiswal 
2009, Majeti 2009}. The progression from normal cell to cancer cell involves changes in genes 
and gene expression that trigger programmed cell death and programmed cell removal {Chao 
2012}. Many of the steps in cancer progression subvert the multiple mechanisms of programmed 
cell death, and the expression of the dominant antiphagocytic signal, CD47, may represent an 
important checkpoint {Chao 2012}. Increased CD47 expression was identified first on leukemic 
stem cells in human acute myeloid leukemia (AML) {Majeti 2009}, and since then it has been 
found that CD47 expression is increased on the surface of cancer cells in a diverse set of human 
tumor types.
Magrolimab is a recombinant humanized anti-CD47 monoclonal antibody that blocks the 
interaction of CD47 with its receptor and enables phagocytosis of human cancer cells {Liu 
2015}. The activity of magrolimab is primarily dependent on blocking CD47 binding to signal 
regulatory protein alpha (SIRPα) and not on the recruitment of crystallizable fragment 
(Fc)-dependent effector functions, although the presence of the immunoglobulin (Ig) G4 Fc 
domain is required for its full activity. For this reason, magrolimab was engineered with a human 
IgG4 isotype that is relatively inefficient at recruiting Fc-dependent effector functions that might 
enhance toxic effects on normal CD47-expressing cells {Liu 2015}. Nonclinical studies using 
xenograft cancer models provide compelling evidence that magrolimab triggers phagocytosis and 
elimination of cancer cells from human solid tumors and hematologic malignancies. Based on 
this mechanism of action (MOA) and its potent nonclinical activity, magrolimab is being 
developed as a novel therapeutic candidate for solid tumors and hematologic malignancies.


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1.2.1.
General Information
For further information on magrolimab, including information on the following, refer to the 
current investigator’s brochure (IB) for magrolimab:
•
Nonclinical pharmacology
•
Pharmacokinetics (PK) and product metabolism in animals
•
Nonclinical toxicology
•
Clinical experience
1.3.
Information About Bevacizumab, FOLFIRI, and Study Auxiliary Medicinal 
Products 
1.3.1.
Role of Chemotherapy in Metastatic Colorectal Cancer
Despite well-known genetic differences in the disease, chemotherapy treatment of CRC is 
largely uniform. Patients with newly diagnosed mCRC are treated with fluoropyrimidine based 
regimens, such as FOLFOX (5-fluorouracil [5-FU], oxaliplatin, and leucovorin [LV]), CAPOX 
(capecitabine and oxaliplatin), or FOLFIRI (5-FU, irinotecan, and LV) alone or in combination 
with therapies that target VEGF or EGFR signaling.
A meta-analysis of 7 Phase 3 studies evaluating therapeutic regimens associating 5-FU/LV, 
oxaliplatin, and irinotecan demonstrated that patients receiving the 3 drugs, regardless of the first 
doublet regimen used, exhibited prolonged survival compared with patients receiving a single 
doublet {Grothey 2004}. However, capecitabine exhibited equivalence to 5-FU and represents a 
well-tolerated alternative association for irinotecan or oxaliplatin. After disease progression, a 
crossover second-line regimen associating fluoropyrimidine/oxaliplatin or 
fluoropyrimidine/irinotecan with another agent exhibited satisfactory response rates along with 
disease stabilized over a period of several months {Tournigand 2004}. The FOLFIRI and 
FOLFOX6 associations were evaluated for postprogression crossover first-line or second-line 
treatment. Both arms exhibited similar response rates (first-line treatment: FOLFIRI 56% versus 
FOLFOX 54% and second-line treatment FOLFIRI 4% versus FOLFOX 15%). There were no 
significant differences in terms of progression-free survival (PFS) (first-line treatment: FOLFIRI 
8.5 months versus FOLFOX 8.0 months and second-line treatment FOLFIRI 2.5 months versus 
FOLFOX 4.2 months) or of overall survival (OS) (FOLFIRI-FOLFOX: 21.5 months versus 
FOLFOX-FOLFIRI 20.6 months).
1.3.2.
Bevacizumab in Metastatic Colorectal Cancer
Progress in molecular biology has enabled better understanding of the cell signaling process 
involved in tumors growth and proliferation, subsequently enabling the development of target 
agents in the treatment of solid tumors. These agents have been devised to interfere with the 
major processes involved in tumor function. The most promising progress at the present time 


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involves VEGF inhibition. The VEGF is a strong factor in tumor angiogenesis, permeability, and 
tumor vascularization survival {Gerber 2005}. The VEGF inhibition induces the destruction of 
recent neomicrovascularization and endothelial cell apoptosis {Erber 2004, Ferrara 2004}. 
One of the most noteworthy VEGF pathway inhibitors is bevacizumab, a humanized monoclonal 
antibody targeting circulatory VEGF and preventing tumor angiogenesis. The binding of 
bevacizumab with VEGF prevents the latter from binding with its endothelial cell membrane 
receptors (Flt-1 and kinase insert domain receptor [KDR]). The interaction of VEGF with its 
receptors, in angiogenesis models, induces tumor growth and neovessel formation.
Randomized clinical studies have shown that bevacizumab combined with 
fluoropyrimidine-based chemotherapy is an effective treatment of patients with mCRC, and such 
combinations are now considered the standard treatment in the first-line and second-line settings 
{Hurwitz 2004, Saltz 2008, Tebbutt 2010}. Various studies have validated bevacizumab efficacy 
in patients who had no prior exposure or were treated with bevacizumab. In the bevacizumab-
naive second-line setting, longer PFS (7.3 versus 4.7 months, hazard ratio [HR] = 0.61, P value 
< 0.001) and OS (12.9 versus 10.8 months, HR = 0.75, P value = 0.0011), as well as a better 
response rate (22.7% versus 8.6%, P value = 0.0001), were observed in the E3200 study 
comparing the combination of FOLFOX and bevacizumab with FOLFOX alone for patients with 
CRC who progressed after FOLFOX therapy {Giantonio 2007}. 
The ML18147 study {Bennouna 2013} and the BEBYP study {Masi 2012} indicate that 
continued VEGF inhibition with bevacizumab plus standard second-line chemotherapy (switched 
over from the first-line regimen) beyond first disease progression significantly prolongs OS and 
PFS in patients with mCRC. Continuation on bevacizumab for those who progressed after first-
line chemotherapy was still helpful for PFS (5.7 versus 4.1 months, HR = 0.68, P value < 0.001) 
and OS (11.2 versus 9.9 months, HR = 0.81, P value = 0.0062) improvement compared with 
standard chemotherapy alone.
1.3.3.
Information on Study Auxiliary Medicinal Products/Noninvestigational 
Medicinal Products
Acetaminophen, diphenhydramine, and corticosteroids are considered auxiliary medicinal 
products (AxMPs) for this clinical study (Appendix 11). Acetaminophen is approved for pain 
relief and fever reduction. Diphenhydramine is an antihistamine and is approved for amelioration 
of allergic reactions. Corticosteroids are anti-inflammatory medications and are used for the 
amelioration of allergic reactions. The use of acetaminophen, diphenhydramine, and 
corticosteroids (eg, dexamethasone) on this study is described in Section 5.5.3 “Premedication 
and Prophylaxis for Magrolimab.” Additional details on acetaminophen, diphenhydramine, and 
corticosteroids (eg, dexamethasone) can be found in the prescribing information.
1.4.
Rationale for This Study
1.4.1.
Retreatment/Rechallenge
Due to few efficacious options in later lines, retreatment with a systemic therapy using an earlier 
line of treatment is common, based on response and toxicity data.


Magrolimab 
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Amendment5 
According to the National Comprehensive Cancer Network (NCCN) guidance for patients who 
had therapy stopped for a reason other than disease progression ( eg, use as adjuvant therapy, 
cumulative toxicity, treatment break, patient preference, etc), rechallenge is an acceptable option. 
1.4.2. 
Therapy Sequencing 
Results from a randomized study to evaluate the efficacy ofFOLFOX and FOLFIRI regimens as 
initial therapy and to detennine the effect of using sequential therapy with the alternate regimen 
after first progression showed neither sequence to be significantly superior with respect to PFS or 
OS. 
There is a conelation with increase in OS if 5-FU, LV, oxaliplatin, and irinotecan are utilized at 
some point in the continuum of care, inespective of order. 
1.4.3. 
Inclusion of Bevacizumab- or anti-EGFR-Experienced Patients 
1.4.4. 
KRAS All-Comers 
1.4.5. 
Combination With Chemotherapy 
1.4.6. 
FOLFIRI as Chemotherapy Backbone 
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1.4.7.
Combination With Bevacizumab
In addition to antiangiogenic properties, targeting the VEGF pathway with bevacizumab has 
been reported to reduce infiltration of immunosuppressive monocyte-derived suppressor cells 
and regulatory T cells as well as to upregulate cytotoxic T cells to the tumor microenvironment.
1.4.8.
Randomization
A 2:1 randomization allows more patients to access experimental treatment and will increase 
study participation.
CCI


Magrolimab 
Protocol GS-US-587-6156 
Gilead Sciences, Inc. 
1.5. 
Rationale for Dose Selection of Magrolimab 
1.6. 
Risk/Benefit Assessment for the Study 
Final 
Amendment5 
Metastatic colorectal cancer ranks as the second most lethal cancer and the third most prevalent 
malignant tumor worldwide. Although screening strategies and new treatment modalities have 
staiied to reduce the overall CRC death rate, the development of advanced metastatic disease is 
still associated with poor long-tenn survival. Recent data has demonstrated a continued decline 
in incidence and mo1iality in patients at least 65 years of age but a converse increase among 
those less than 65 yeai·s of age. 
Systemic chemotherapy in combination with anti-EGFR antibodies such as cetuximab and 
panitummnab have significantly improved prognosis in KRAS wild-type patients {Lee 2015}. In 
addition, patients with MSI-H have demonstrated impressive responses to checkpoint inhibitors 
such as pembrolizumab {Le 2015, Ovennan 2016}, but this represents only a subset of this 
tumor type (10% to 15% at diagnosis). On the other hand, certain subsets of patients such as 
those with KRAS mutations, which comprise over 40% of CRCs do not respond to anti-EGFR 
antibody therapies {Allegra 2009}. Patients with KRAS-mutant mCRC have a poorer prognosis 
while having limited available therapies. For the majority of patients who are ineligible or unable 
to derive benefit from novel targeted therapies or immunotherapies, SOC doublet or triplet 
chemotherapy based regimens that ai·e associated with systemic toxicity, unsatisfying response 
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Final 
Amendment5 
rates, unpredictable innate and acquired resistance, as well as low tumor-specific selectivity are 
the only available treatment options. Therefore, significant and clinically relevant improvements 
in efficacy that advance the treatment landscape are still needed to address this high unmet 
medical need in patients with CRC. 
Magrolimab is a recombinant humanized anti-CD47 monoclonal antibody that blocks the 
interaction of CD47 with its receptor and enables phagocytosis of human cancer cells. 
Nonclinical studies using xenograft cancer models provide compelling evidence that magrolimab 
triggers phagocytosis and elimination of cancer cells from human solid tumors and hematologic 
malignancies. Based on this MOA and its potent nonclinical activity, magrolimab is being 
developed as a novel therapeutic candidate for solid tumors and hematologic malignancies. 
An infectious disease pandemic may pose additional risks to study drng availability, the study 
visit schedule, and adherence to protocol-specified safety monitoring or laborato1y assessments. 
Refer to Appendix 3 for fmi her details on the risks and risk mitigation strategy. 
In summa1y, based on strong scientific rationale, nonclinical, and the lack of substantial 
anticipated overlapping toxicities with the proposed magrolimab combination regimens, this 
study has an acceptable risk: benefit ratio for patients who paiiicipate. 
1.7. 
Compliance 
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulato1y requirements. 
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Amendment5 
2_ 
OBJECTIVES AND ENDPOINTS 
Primary Objectives 
Safety Run-in Cohort: 
• 
To evaluate the safety, tolerability, and 
recommended Phase 2 dose (RP2D) of 
magrolimab in combination with 
bevacizumab and FOLFIRI in previously 
treated patients with advanced inoperable 
mCRC 
Randomized Cohort: 
• 
To evaluate the efficacy of magrolimab in 
combination with bevacizumab and FOLFIRI 
in mCRC as detennined by PFS by 
investigator assessment 
Secondary Objectives 
Randomized Cohort: 
Primary Endpoints 
Safety Run-in Coho1t: 
• 
Incidence of dose-limiting toxicities (DLTs), adverse 
events (AEs), and laboratory abno1malities according 
to National Cancer Institute (NCI) Common 
Tenninology Criteria for Adverse Events (CTCAE), 
Version 5.0 
Randomized Cohort: 
• 
PFS, defined as the time from the date of 
randomization until the earliest date of documented 
disease progression as detennined by investigator 
assessment using Response Evaluation Criteria in Solid 
Tumors Version 1.1 (RECIST Vl .1 ), or death from 
any cause, whichever occurs first 
Secondary Endpoints 
Randomized Cohort: 
• 
To evaluate objective response rate (ORR) by 
• 
Confinned ORR, defined as the proportion of patients 
with complete response (CR) or partial response (PR) 
on 2 consecutive assessments, at least 28 days apart, as 
detennined by investigator assessment using RECIST 
Vl.1 
investigator assessment 
• 
To evaluate additional measures of efficacy of 
magrolimab in combination with 
bevacizumab and FOLFIRI, including 
duration of response (DOR) and OS 
• 
DOR, defined as time from first documentation of CR 
or PR to the earliest date of documented disease 
progression as detennined by investigator assessment, 
per RECIST Vl. l , or death from any cause, whichever 
occurs first 
• 
To evaluate patient-reported outcomes 
(PRO)/quality-of-life measures for the 
Randomized Cohort in mCRC with 
magrolimab in combination with 
bevacizumab and FOLFIRI 
• 
OS, defined as time from date of randomization to 
death from any cause 
Safety Run-in and Randomized Coho1t: 
• 
To evaluate the PK and immunogenicity of 
magrolimab in combination with 
bevacizumab and FOLFIRI 
• 
PRO assessments (European Organisation for Research 
and Treatment of Cancer Quality of Life Questionnaire 
- Core Questionnaire [EORTC-QLQ-C30], the 5-level 
EuroQol 5 dimensions questionnaire [EQ-5D-5L]) 
scores, and Functional Assessment of Cancer Therapy 
[FACT] Colorectal Symptom Index [FCSI] 
Safety Run-in and Randomized Coho1ts: 
• 
Magrolimab concentration versus time and antidrng 
antibodies (ADA) to magrolimab 
Exploratory Objectives 
Exploratory Endpoints 
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3_ 
STUDY DESIGN 
3.1. 
Study Design Overview 
Final 
Amendment5 
This is a Phase 2, randomized, open-label, multicenter study to evaluate magrolimab in 
combination with bevacizumab and FOLFIRI in reviousl treated atients with advanced 
This study will consist of the following 2 coho1ts: 
• 
Safety Run-in Cohort: magrolimab in combination with bevacizumab and FOLFIRI in 
previously treated patients with advanced inoperable mCRC 
After completion of the Safety Run-in Coho1t, the Randomized Coho1t will be open to 
emollment. 
• 
Randomized Cohort: magrolimab in combination with bevacizumab and FOLFIRI 
(Experimental Alm A) versus bevacizumab and FOLFIRI (Control Alm B) in previously 
treated patients with advanced inoperable mCRC. 
The study schema is presented in Figure 1. 
3.1.1. 
Safety Run-in Cohort 
Initially, approximately 6 patients will be emolled in the Safety Run-in Coho1t at a sta1ting dose 
level. A DLT-assessment period of28 days will occur (see Section 3.1.1.1). 
Although no dose-dependent toxicities have been observed with magrolimab, in order to 
preserve the efficacious doses of the combination pa1tner dmgs, dose de-escalation will take 
place for magrolimab as follows: 
I 
I 
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3.1.1.1.
Dose-Limiting Toxicity Assessment Period for Safety Run-in Cohort
The DLT-assessment period will be the first 28 days and applies to the Safety Run-in Cohort. 
Patients are considered evaluable for assessment of a DLT if either of the following criteria is 
met in the DLT-assessment period:
•
The patient experienced a DLT at any time after initiation of the first infusion of magrolimab.
•
The patient did not experience a DLT and completes at least 3 infusions of magrolimab and 
at least 2 doses of bevacizumab and FOLFIRI in the Safety Run-in Cohort.
If a patient experiences a DLT during the DLT-assessment period, the patient will discontinue 
treatment. Patients who are not evaluable for DLT assessment in the Safety Run-in Cohort will 
be replaced.
Patients enrolled in the Safety Run-in Cohort may continue treatment at the RP2D until 
unacceptable toxicity, disease progression, or other protocol-specified discontinuation.
3.1.1.2.
Dose-Limiting Toxicity Definition for Safety Run-in Cohort
All toxicities will be graded according to the NCI CTCAE, Version 5.0 (Appendix 5).
A DLT is defined as any:
•
Grade 3 or higher hematologic toxicity including
Grade 3 hemolytic anemia that is medically significant, requiring hospitalization or 
prolongation of existing hospitalization, disabling, or limiting self-care activities of daily 
life
Grade 4 neutropenia lasting > 7 days, regardless of supporting measures
•
An event meeting Hy’s Law criteria (Section 7.7).
•
Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment 
baseline during the DLT-assessment period.
•
Grade 3 fatigue lasting > 7 days.
•
In the opinion of the investigator, the AE is at least possibly related to magrolimab.
The following are exceptions to the DLT definition and are not considered a DLT:
•
Grade 3 anemia. 
•
Grade 3 febrile neutropenia that has responded clinically within 72 hours of maximal 
supportive care.


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•
Grade 3 neutropenia that resolves to Grade 2 or pretreatment/baseline with supportive care 
(including growth factors) within 21 days or Grade 4 neutropenia lasting for 7 days or less 
with supportive measures.
•
Grade 3 thrombocytopenia in the absence of clinically significant bleeding that resolves to 
Grade 2 or pretreatment/baseline within 3 weeks.
•
Grade 3 indirect/unconjugated hyperbilirubinemia that resolves to Grade 2 or lower with 
supportive care within 1 week and is not associated with other clinically significant 
consequences.
•
Grade 3 electrolyte abnormalities that improve to less than or equal to Grade 2 or baseline 
within 72 hours, are not clinically complicated, and resolve spontaneously or respond to 
conventional medical interventions.
•
Grade 3 elevation in alanine aminotransferase (ALT) and/or aspartate aminotransferase 
(AST) up to 8  upper limit of normal (ULN) lasting less than 7 days. Grade 3 elevation in 
alkaline phosphatase that resolves to Grade 2 or lower with supportive care within 1 week 
and is not associated with other clinically significant consequences.
•
Grade 3 nausea/vomiting or diarrhea that resolves to Grade 2 or lower within 72 hours with 
adequate antiemetic and other supportive care.
•
Grade 3 fatigue that resolves to Grade 2 or lower within 1 week.
•
Grade 3 infusion reactions in the absence of an optimal pretreatment regimen, which is 
defined in Section 5.5.3.
•
Grade 3 tumor lysis syndrome or electrolyte disturbances (hyperkalemia, hypophosphatemia, 
hyperuricemia) that resolve to less than or equal to Grade 2 or baseline within 72 hours.
•
Grade 3 hypomagnesemia that resolves to less than or equal to Grade 2 or baseline within 
72 hours.
•
Grade 3 or 4 lymphopenia or leukopenia not associated with other clinically significant 
consequences.
•
Transient (≤ 48 hours) Grade 3 local reactions, flu-like symptoms, myalgias, fever, headache, 
acute pain, or skin toxicity that resolves to Grade 2 or lower within 72 hours after medical 
management (eg, supportive care, including immunosuppressant treatment) has been 
initiated.
•
Tumor flare phenomenon, defined as local pain, irritation, or rash localized at sites of known 
or suspected tumor, that resolves within 72 hours with supportive care measures.
•
Grade 3 lipase and/or amylase elevation without clinical or radiologic evidence of 
pancreatitis.


Magrolimab 
Protocol GS-US-587-6156 
Gilead Sciences, Inc. 
Final 
Amendment5 
3.1.1.2.1. 
Safety Review Team 
A Safety Review Team (SRT) will make dose selection and/or dose modification decisions for 
individual patients based on data described in Section 3 .1.1. 
An SRT chaiier defining the team membership, meeting conduct, and decision-making process 
will be agreed upon by all team members before the first meeting. The data reviewed at the team 
meetings to make dose selection and/or dose modification (including dose escalation or dose 
reduction) decisions will be defined in the chaiter. The quality control checks perfonned on the 
data reviewed and used for making dose selection and/or dose modification decisions will also be 
described in the cha1ter. 
3.1.2. 
Randomized Cohort 
Once the Safety Run-in Coho1i is completed and the RP2D for magrolimab in combination with 
bevacizumab and FOLFIRI is determined, the sponsor will open the Randomized Cohort. 
In this open-label, randomized, 2-aim study, patients with mCRC will be randomized in a 
2:1 ratio to receive either magrolimab in combination with bevacizumab and FOLFIRI 
(Experimental Alm A) or bevacizumab and FOLFIRI (Control Alm B). 
The primaiy efficacy assessment will be investigator assessed PFS, with the primaiy analysis to 
occur after 85 PFS events. Stratification factors for randomization include the following: 
(1) KRAS mutation/unknown versus wild-type status, (2) geographic region (US versus EU/rest 
of world [ROW]), (3) presence versus absence of liver metastases. 
3.1.2.1. 
Treatment-Related Toxicity Monitoring 
Treatment-related toxicity will be monitored by a Gilead Data Review Committee (GDRC) at a 
Table 4. 
ncy with the stopping boundai·ies shown in Table 4. The GDRC will convene after 
• 
from Alm A ai·e treated at the dose level for the Randomized Phase 2 Coho1i 
of follow-up, and thereafter when safety data from I Alm A patients from 
ome available. The frequency of GDRC review will be outlined in the 
IS IS a 
Stopping Boundaries Due to Toxicity (Phase 2 Randomized Cohort 
Arm A) 
• 
TEAE = treatment-emergent adverse event 
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Gilead Sciences, Inc. 
3.2. 
Study Treatments 
Final 
Amendment5 
Details regarding the doses and dosing regimens of magrolimab, bevacizumab, and FOLFIRI are 
provided in Sections 5.5 and 5.6. Details regarding the fonnulation, packaging, and labeling of 
magrolimab, bevacizumab, and FOLFIRI are provided in Sections 5.2, 5.3, and 5.4. 
3.3. 
Duration of Treatment 
All patients will continue study ti·eatment unless they meet study ti·eatment discontinuation 
criteria (Section 3.4). Magrolimab can be continued if combination partner chugs (ie, FOLFIRI 
and/or bevacizumab) are discontinued for unacceptable toxicity. Combination partner chugs can 
be continued if magrolimab is discontinued for unacceptable toxicity. 
I 
I 
I 
I 
3.4. 
3.4.1. 
I 
I 
Discontinuation Criteria 
Early Discontinuation From Study Treatment 
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I 
I 
I 
I 
3.4.2. 
Early Discontinuation From the Study 
Final 
Amendment5 
A patient may pennanently discontinue from the study for reasons including but not limited to 
the following: 
• 
Death 
• 
Pregnancy 
• 
Investigator decision to remove patient from the study 
• 
Protocol violation by the patient 
• 
Patient request, with or without a stated reason 
• 
Patient lost to follow-up 
• 
Study tenninated by the sponsor 
• 
Withdrawal of consent 
Procedmes for patients who discontinue the study early are described in Section 6.4. 
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Gilead Sciences, Inc. 
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3.5.
Definitions for Time of Primary Endpoint and End of Study
3.5.1.
Primary Endpoint
The date for the last patient’s visit for the primary endpoint is the date of the last visit to perform 
assessments for the primary analysis.
3.5.2.
End of Study
All patients: the end of the entire study for all patients is defined as the date on which the last 
patient remaining on study completes the last study visit/call or when the sponsor decides to end 
the study. The sponsor reserves the right to terminate the study at any time for any reason 
(including safety).
Individual patients: patients are considered to have completed study participation altogether 
when they are no longer followed for survival.
All patients will be followed for survival until death, withdraw from consent, lost to follow-up, 
and the end of study, whichever occurs first.
For any patient who dies during this follow-up period, the immediate cause of death must be 
reported to the sponsor.
3.6.
Poststudy Care 
After the patient has completed/terminated their participation in the study, long-term care of the 
patient will remain the responsibility of their primary treating physician.
3.7.
Source Data
The source data for this study will be obtained from original records (eg, clinic notes, hospital 
records, patient charts), central laboratory, local laboratory, and/or specialty laboratory (for PK, 
ADA, and/or PD data) and/or additional biomarker testing, interactive response technology 
(IRT), imaging, and PRO.


Magrolimab 
Protocol GS-US-587-6156 
Gilead Sciences, Inc. 
4_ 
PATIENT POPULATION 
4.1. 
Number of Patients and Patient Selection 
Final 
Amendment5 
Approximately 135 patients may be emolled in the study, with approximately 6 to 18 patients in 
the Safety Run-in Coho1t (additional patients could be enrolled in this coho1t or in dose 
de-escalation coho1ts) and approximately 117 patients in the Randomized Coh01t Anns A and B. 
4.1.1. 
Patient Replacement 
Patients may be replaced in the Safety Run-in Coho1ts if not evaluable for DLT assessment, as 
described in Section 3 .1.1. 
4.2. 
Inclusion Criteria 
All patients must meet all of the following inclusion criteria to be eligible for paiticipation in this 
study: 
1) Patient has provided info1med consent. 
2) Patient is willing and able to comply with clinic visits and procedures outlined in the study 
protocol. 
3) Male or female, at least 18 years of age. 
4) Previously treated patients with inoperable mCRC who have progressed on or after 1 prior 
systemic therapy and who are ineligible for checkpoint inhibitor therapy ( eligible patients for 
checkpoint inhibitor therapy ai·e defined as MSI-H or mismatch repair deficient [dMMR] and 
ai·e excluded). Note: maintenance therapies ai·e not counted as sepai·ate lines of therapy. 
5) 
6) Histologically or cytologically confomed adenocai·cinoma originating in the colon or rectum 
(excluding appendiceal and anal canal cancers) who have progressed on or after 1 prior 
systemic therapy in the setting where curative resection is not indicated. This therapy must 
have included chemotherapy based on 5-FU or capecitabine with oxaliplatin and either 
bevacizumab, or for patients with RAS wild-type and left-sided tumors, bevacizumab, 
cetuximab, or panitumumab. 
7) Measurable disease at least 1 measurable metastatic lesion b 
8) Patients must have an ECOG perfo1mance status of 0 or 1. 
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9) Life expectancy of at least 12 weeks. 
10) Laborato1y measurements, blood counts: 
a) 
b) 
c) Platelets at least 100 x 109 /L. 
11) Adequate liver function, 
12) Patients must have ade uate renal function 
13) Pretreatment blood cross-match completed (see Section 7.8.1.2). 
15) Criterion removed. 
4.3. 
Exclusion Criteria 
Final 
Amendment 5 
Patients who meet any of the following exclusion criteria are not to be emolled in this study: 
1) Prior anticancer therapy including chemotherapy, ho1monal therapy, or investigational agents 
within 3 weeks or within at least 4 half-lives prior to magrolimab dosing (up to a maximum 
of 4 weeks), whichever is shorter. 
2) Known BRAF V600E or MSI-H mutations or dMMR. 
3) Persistent Grade 2 or more gastrointestinal bleeding. 
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4) 
5) Patients with prior irinotecan therapy. 
6) Criterion removed. 
7) 
Final 
Amendment 5 
8) Clinically significant corona1y arte1y disease or myocardial infarction within 6 months prior 
to inclusion. 
9) Peripheral neuropathy of more than Grade 2 (CTCAE Version 5.0). 
10) Known dihydropyriinidine dehydrogenase deficiency. 
11) Acute intestinal obstrnction or subobstrnction, histo1y of inflammato1y intestinal disease or 
extended resection of the small intestine. Presence of a colonic prosthesis. 
12) Unhealed wound, active gastric or duodenal ulcer, or bone fracture. 
13) Histo1y of abdominal fistulas, trachea-oesophageal fistulas, any other Grade 4 
gastrointestinal perforations, nongastrointestinal fistulas, or intrn-abdominal abscesses 
6 months prior to screening. 
15)Histo1y ofhype1iensive crisis or hype1iensive encephalopathy. 
16) Thromboembolic event in the 6 months before inclusion ( eg, trnnsito1y ischemic stroke, 
strnke, subarachnoid hemoIThage) except peripheral deep vein thrombosis ti·eated with 
anticoagulants. 
19) Active centi·al nervous system (CNS) disease. Patients with asymptomatic and stable, ti·eated 
CNS lesions (radiation and/or surge1y and/or other CNS-directed therapy who have not 
received co1iicosteroids for at least 4 weeks) are allowed. 
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Final 
Amendment5 
20) RBC transfusion dependence, defined as requiring more than 2 units of packed RBC 
transfusion d • 
th 4 
k 
• d 
• t 
• 
RBC tr 
fu • 
mitted 
• 
• 
• 
• 
• 
during the 
21) Histo1y of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 
3 months. 
22) Known hypersensitivity to any of the study mugs, the metabolites, or fo1mulation excipient. 
25) Known inherited or acquired bleeding disorders. 
26) Significant disease or medical conditions, as assessed b the investi ator an 
. 
. 
. 
27) Second malignancy, exce t tr·eated basal cell or localized s uamous skin carcinomas, 
localized rostate cancer, 
28) Known active or chronic hepatitis B or C infection. Hepatitis B or C patients not cmTently on 
antiviral therapy and who have an undetectable viral load in the prior 3 months may be 
eligible for the study. Patients with serologic evidence of prior vaccination to hepatitis B 
vims (ie, hepatitis B surface antigen negative and antibody against hepatitis B surface antigen 
positive) may paiiicipate. 
29) Uncontr·olled pleural effusion. 
32) Severe/serious systeinic infection within 4 weeks of randomization or any active, 
uncontl'olled infection requiring systeinic therapy within 7 days of randoinization. 
33) Presence of a detectable HIV viral load in patients with a known histo1y of HIV. 
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5_ 
5.1. 
5.1.1. 
STUDY DRUGS 
Randomization, Blinding, and Treatment Codes Access 
Randomization 
Final 
Amendment5 
Patients who are eligible for the Randomized Cohort will be randomized in a 2: 1 ratio to receive 
either magrolimab + bevacizumab + FOLFIRI or bevacizumab + FOLFIRI sta1ting on the Day 1 
visit and assigned a patient number. 
5.1.2. 
Blinding 
Blinding of treatment assignments or data will not be perfonned in this open-label study. 
5.2. 
5.2.1. 
5.2.2. 
Description and Handling of Magrolimab 
Formulation 
Packaging and Labeling 
Study dmg(s) to be distributed to centers in the US and other pa1ticipating countries shall be 
labeled to meet applicable requirements of the US Food and Drng Administration (FDA), EU 
Guidelines to Good Manufacturing Practice, Annex 6 for Clinical Trials Regulation (CTR), 
and/or other local regulations. 
5.2.3. 
Storage and Handling 
Do not shake. Storage conditions are specified on the label. 
Refer to the Phannacy Manual for instrnctions on repo1ting temperature excursions. Until 
dispensed to the patients, study dmgs should be stored in a securely locked area, accessible only 
to authorized site personnel. 
To ensure stability and proper identification, study diug(s) should not be stored in a container 
other than the container in which they were supplied. 
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Gilead Sciences, Inc. 
Amendment 5
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Consideration should be given to handling, preparation, and disposal through measures that 
minimize drug contact with the body. Appropriate precautions should be followed to avoid direct 
eye contact or exposure when handling.
5.3.
Description and Handling of Bevacizumab
5.3.1.
Formulation
Information regarding the formulation of bevacizumab can be found in the local prescribing 
information. 
The use of an approved biosimilar is permitted upon approval by the sponsor. 
5.3.2.
Packaging and Labeling
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guidelines to Good Manufacturing 
Practice, Annex 6 for CTR, and/or other local regulations. Alternatively, in alignment with local 
regulations commercial product may be sourced locally by the sites.
5.3.3.
Storage and Handling
Further information regarding storage and handling of bevacizumab is available in the local 
prescribing information.
5.4.
Description and Handling of FOLFIRI
5.4.1.
Formulation
Information regarding the formulation of FOLFIRI (irinotecan, LV, and 5-FU) can be found in 
the local prescribing information for each agent {CAMPTOSAR 2020, FLUOROURACIL 2016, 
LEUCOVORIN 2011, LEVOLEUCOVORIN 2016}.
5.4.2.
Packaging and Labeling
Study drugs to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guidelines to Good Manufacturing 
Practice, Annex 6 for CTR, and/or other local regulations. Alternatively, in alignment with local 
regulations commercial product may be sourced locally by the sites.
5.4.3.
Storage and Handling
Further information regarding storage and handling of FOLFIRI (irinotecan, LV, and 5-FU) is 
available in the local prescribing information for each agent {CAMPTOSAR 2020, 
FLUOROURACIL 2016, LEUCOVORIN 2011, LEVOLEUCOVORIN 2016}.
Study treatments for the Safety Run-in Cohort and the Randomized Cohort are summarized in 
Table 5 and Table 6, respectively.


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5.5. 
Dosage and Administration of Magrolimab 
The magrolimab dosing regimen for the safety nm-in and randomized coho1is is presented in 
Table 5 and Table 6. Treatment administration and associated assessment schedules for 
magrolimab repriming are provided in Appendix Table 1. 
Table 5. 
Safety Run-in Cohort Dosing and Dose De-escalation Regimen 
Dose Schedule (Day per 28-Day Cycle) 
Drug/Dose/Route 
Cycle 1 
Cycle 2 
Cycle3+ 
Bevacizumab 
Days 1, 15 
Days 1, 15 
Days 1, 15 
5 mg/kg IV eve1y 2 weeks• 
FOLFIRIIV1> 
Days 1, 15 
Days 1, 15 
Days 1, 15 
Irinotecan 180 mg/m2 over 30-90 minutes on first 
day of dose administration 
Leucovorin 400 mg/m2 over 2 hours on first day 
of dose administrationc 
Fluorouracil 400 mg/m2 bolus on first day of dose 
administration, followed by 2400 mg/m2 over 
46 hours, continuous infusion 
Magrolimab Administration 
Magrolimab 
1 mg/kg IV (3 hours ± 30 min) 
Magrolimab starting dose level 
30 mg/kg IV (2 hours ± 30 min) 
Magrolimab 
30 mg/kg IV (2 hours ± 30 min) 
Magrolimab de-escalation Level - 1 
20 mg/kg IV (2 hours ± 30 min) 
Magrolimab de-escalation Level - 2 
15 mg/kg IV (2 hours ± 30 min) 
Day 1 
QW beginning at Day 8 visit and the next 6 doses 
(Cycle 1 Days 8, 15, and 22, Cycle 2 Days 1, 8, 15, and 22) 
Q2W beginning 1 week after the last weekly 30 mg/kg dose 
(sta1t ing Cycle 3 Day 1 onward) 
QW beginning at Day 8 visit and the next 6 doses 
(Cycle 1 Days 8, 15, and 22, Cycle 2 Days 1, 8, 15, and 22) 
Q2W beginning 1 week after the last weekly 20 mg/kg dose 
(starting Cycle 3 Day 1 onward) 
QW beginning at Day 8 and the next 6 doses 
(Cycle 1 Days 8, 15, and 22, Cycle 2 Days 1, 8, 15, and 22) 
Q2W beginning 1 week after the last weekly 15 mg/kg dose 
(starting Cycle 3 Day 1 onward) 
FOLFIRI = 5-fluorotu·acil, itinotecan, and leucovorin; IV = intravenous; QW = eve1y week; Q2W = eve1 
a 
Bevacizumab should be administered er standard of care and/or institutional . idelines. 
b 
c 
Levo eucovonn 200 m m may e used ifleucovorin is unavailable. Generics for leucovorin or levoleucovorin are also 
pemiitted. Leucovo1in and levoleucovo1in should be administered per standard of care and/or institutional guidelines. 
Recommendations include administering the first dose over 2 hotu·s. Different leucovorin doses may be used if 
recommended by regional or institutional guidelines. 
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Table 6. 
Randomized Cohort Dosing Regimen 
Dose Schedule (Day per 28-Day Cycle) 
Drug/Dose/Route 
Cycle 1 
Cycle 2 
Cycle3+ 
Bevacizumab 
Days 1, 15 
Days 1, 15 
Days 1, 15 
5 mg/kg IV eve1y 2 weeks• 
FOLFIRIIV1> 
Days 1, 15 
Days 1, 15 
Days 1, 15 
Irinotecan 180 mg/m2 over 30-90 minutes on first 
day of dose administration 
Leucovorin 400 mg/m2 over 2 hours on first day 
of dose administrationc 
Fluorouracil 400 mg/m2 bolus on first day of dose 
administration, followed by 2400 mg/m2 over 
46 hours, continuous infusion 
Magrolimab Administration 
Magrolimab 
1 mg/kg IV (3 hours ± 30 min) 
Magrolimab 
RP2D IV (2 hours ± 30 min) 
Magrolimab 
RP2D IV (2 hours ± 30 min) 
Day 1 
QW beginning at Day 8 visit and the next 6 doses 
(Cycle 1 Days 8, 15, and 22, Cycle 2 Days 1, 8, 15, and 22) 
Q2W beginning 1 week after the last weekly RP2D 
(starting Cycle 3 Day 1 onward) 
FOLFIRI = 5-fluorouracil irinotecan, and leucovorin; IV = intravenous; QW = eve1y week; Q2W = eve1y 2 weeks; 
b 
c 
eve eucovonn 
m m may e used ifleucovorin is unavailable. Generics for leucovorin or levoleucovorin are also 
pemiitted. Leucovorin and levoleucovorin should be administered per standard of care and/or institutional guidelines. 
Recommendations include administering the first dose over 2 hotu·s. Different leucovorin doses may be used if 
recommended by regional or institutional guidelines. 
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Table 7. 
Repriming Guidelines for Magrolimab 
Minimum Duration of Treatment 
Dose 
Dosing Frequency 
Gap That Will Lead to Repriming 
1 mg/kg 
NA - used at initial priming 
2 we.eks 
15 mg/kg 
Weekly or more frequent 
2 we.eks 
(Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22) 
Eve1y 2 weeks (from Cycle 3 Day 1) 
4 we.eks 
20mg/kg 
Weekly or more frequent 
2 we.eks 
(Cycle 1 Days 8, 15, 22; Cycle 2 Days 1, 8, 15, 22) 
Eve1y 2 weeks (from Cycle 3 Day 1) 
4 we.eks 
30 mg/kg 
Weekly or more frequent 
2 we.eks 
(Cycle 1 Days 8, 15, 22; Cycle 2 Days 1, 8, 15, 22) 
30 mg/kg 
Eve1y 2 weeks (from Cycle 3 Day 1) 
4 we.eks 
NA = not applicable 
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5.6. 
Dosage and Administration of Bevacizumab and FOLFIRI 
Final 
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The bevacizumab and FOLFIRI dosing regimen for the safety nm-in and randomized coho1is is 
presented in Table 5 and Table 6. 
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5.7. 
5.7.1. 
Prior and Concomitant Medications 
Permitted Concomitant Medications for All Cohorts 
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For the regimens administered with magrolimab in this study, the cmTent local or regional 
prescribing infonnation should be consulted regarding permitted and prohibited concomitant 
medications. 
Premedication, as well as prophylaxis for AEs as described in Section 5.5.3, are pennitted while 
on study treatment. 
All concomitant medications, including all prescription, over-the-counter, herbal supplements, 
and IV medications and fluids received after info1med consent through the study treatment 
period, through the 30-day safety follow-up visit should be recorded in the eCRF. 
5.7.2. 
Coronavirus Disease 2019 (COVID-19) Vaccine 
There is no contraindication to the COVID-19 vaccine with magrolimab. There is no specific 
recommendation on the timing of a COVID-19 vaccine; individuals may receive the vaccine 
when available. However, if these patients are neutropenic, investigators may use local guidance 
as well as clinical judgment in detennining the timing of the COVID-19 vaccine. Investigators 
should document vaccinations. Investigators should notify patients of the risks of delaying the 
COVID-19 vaccination and document this along with any mitigation strategies for preventing 
COVID-19 infection. 
5.7.3. 
Prohibited Concomitant Medications 
Anticancer therapies including chemotherapy, targeted therapies, and immunotherapy (apart 
from study diugs) are not pe1mitted while patients are on study. 
5.8. 
Accountability for Study Drug(s) 
The investigator is responsible for ensming adequate accountability of all used and unused study 
diug (kits, vials, etc). This includes acknowledgment of receipt of each shipment of study diug 
(quantity and condition). All used and unused study di11g (kits, vials, etc) dispensed to patients 
must be retmned to the site. 
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Each investigational site must keep accountability records that capture:
•
The date received, quantity, and condition of study drug (kits, vials, etc)
•
The date, patient number, and the study drug (kits, vials, etc) number dispensed
•
The date, quantity of used and unused study drug (kits, vials, etc) returned, along with the 
initials of the person recording the information
5.8.1.
Study Drug Return or Disposal
Gilead recommends that used and unused study drug supplies be destroyed at the site. If the site 
has an appropriate standard operating procedure for drug destruction as determined by Gilead, 
the site may destroy used (empty or partially empty) and unused study drug supplies in 
accordance with that site’s approved procedural documents. A copy of the site’s approved 
procedural document will be obtained for the electronic trial master file. If study drug is 
destroyed at the site, the investigator must maintain accurate records for all study drugs 
destroyed. Records must show the identification and quantity of each unit destroyed, the method 
of destruction, and the person who disposed of the study drug. Upon study completion, copies of 
the study drug accountability records must be filed at the site. Another copy will be provided to 
Gilead. 
If the site does not have an appropriate standard operating procedure for drug destruction, used 
and unused study drug supplies are to be sent to the designated disposal facility for destruction. 
The study monitor will provide instructions for return.
The study monitor will review study drug supplies and associated records at periodic intervals.


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6_ 
STUDY PROCEDURES 
Final 
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The study procedures to be conducted for each patient screened or emolled in the study are 
presented in tabular fonn in Table 1, Table 2, and Table 3 and are described in the sections below. 
The investigator must doclllllent any deviation from the protocol procedures and notify Gilead or 
the contract research organization. 
6.1. 
Informed Consent 
Written infonned consent must be obtained from each patient before initiation of any study-related 
procedures. Refer to Section 9 .1.4 for fmiher inf01mation regarding info1med consent. 
6.1.1. 
Informed Consent for Optional Research 
In addition to the study-specific info1med consent f01m to be signed by each patient paiiicipating 
in the study, patients will be required to doclllllent additional consent to provide the following, in 
accordance with applicable regulations: 
• 
6.2. 
Prescreening, Screening, Patient Enrollment, and Treatment Assignment 
An IRT system will be employed to manage the conduct of the study. The IRT will be used to 
maintain a central log documenting emollment, to assess cmTent inventories of study diug, to 
initiate any necessaiy resupply of study dmg, and to document discontinuation of study diug. 
Patients will be screened within 30 da s before enrollment/randomization in the stud . 
Each patient will be assigned a unique screening 
nlllll er usmg t e IRT. Patients meetmg a 1 of the inclusion criteria and none of the exclusion 
criteria will retmn to the clinic within 30 days for emollment/randomization into the study 
staiiing on Cycle 1 Day 1 and assigned a patient number and treabnent ann by the IRT. 
Rescreening will be pennitted. Assessments perfo1med as paii of standai·d of cai·e prior to ICF 
signature may be used if they ai·e within the required screening period. 
Entiy into screening does not guai·antee enrollment into the study. In order to manage the total 
study emollment, Gilead, at its sole discretion, may suspend screening and/or emollment at any 
site or study wide at any time. 
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6.2.1. 
Prescreening 
Prior to providing consent for the study, an optional prescreening consent fo1m ma 
atients at the investi ator's discretion to e1mit the collection and anal sis of 
6.3. 
Instructions for Study Procedures 
Study procedures and assessments are outlined in Table 1, Table 2, and Table 3. 
6.3.1. 
Adverse Events 
Final 
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From the time info1med consent is obtained through the first administration of study dmg, record 
serious adverse events (SAEs) that are considered related to protocol-mandated procedures on 
the AE eCRF. All other untoward medical occunences observed during the screening period, 
including exacerbation or changes in medical histo1y, are to be considered medical histo1y. After 
study dmg administration, repo1t all AEs and SAEs. Additional details are provided in Section 7. 
6.3.2. 
Type and Screen and Direct Antiglobulin Test 
Please refer to Section 7.8.1.1 for detailed guidance on type and screen and DAT. 
6.3.3. 
Concomitant Medications 
Review of conc01nitant medications will occur at the time points presented in Table 1, Table 2, 
and Table 3. 
All conc01nitant medications taken by the patient while on study are to be documented. Changes 
in baseline conc01nitant medication infonnation is to be collected after infonned consent through 
the study treatment period, and until 30-day safety follow-up visit. Concoinitant medication 
associated with procedure-related AEs will be captured from the time of info1med consent and 
onward. Info1mation to be collected includes drng name, indication, route, sta1t date, and stop 
date, and must be repo1ted using the applicable eCRF. Note that any anticancer therapies after 
the study treatment period should also be collected per the schedule of assessments. 
6.3.4. 
Pregnancy Test 
Pregnancy tests are required only for female patients of childbearing potential (see Appendix 4 
for definition of childbearing potential). Pregnancy tests are perfo1med as specified in the 
schedule of assessments (Table 1, Table 2, and Table 3). 
6.3.5. 
Physical Examination 
Complete physical examination should be perfonned at screening. Symptom-directed physical 
are perfo1med from Day 1. 
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6.3.6. 
Vital Signs, Weight, and Height 
Final 
Amendment 5 
Vital signs should include heart rate, respirato1y rate, oxygen saturation, blood pressure, 
temperature, and weight. Height should be recorded dming screening only. Weight should be 
recorded during screening and eve1y 4 weeks thereafter. Vital signs are to be recorded prior to 
dosing of study treatment at the visits specified in the schedule of assessments (Table 1, Table 2, 
and Table 3). Vital signs will be collected postdose (as clinically appropriate). 
6.3.7. 
Electrocardiograms 
A single electrocardiogram (ECG) will be perfo1med at screening. 
6.3.8. 
Performance Status 
Perfo1mance status will be scored using the ECOG perfonnance status scale index (refer to 
Appendix 6). 
6.3.9. 
Clinical Laboratory Assessments 
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6.3.10. 
Efficacy Assessments 
Final 
Amendment5 
Appropriate cancer staging assessments should be perfo1med. Imaging assessments are to be 
conducted according to the RECIST Vl .1 criteria for solid tumors {Eisenhauer 2009}. The same 
imaging modality used at screening should be used throughout the study whenever possible. It is 
understood that some circumstances may require a different imaging modality. An alternate 
imaging modality is acceptable and may be peiformed at the investigator's discretion. 
Per RECIST criteria, if a patient achieves an initial objective response (CR/PR) on imaging, an 
imaging assessment at least 4 weeks later is required to confnm the response. 
6.3.11. 
Pharmacokinetics 
Magrolimab senun concentration will be measured by a validated enzyme-linked irmnunosorbent 
assay irmnunoassay method. 
Blood samples for PK assessment will be collected at predose at multiple time points from 
patients who received magrolimab according to the schedule of assessments in Table 2 (note the 
additional sample collected postdose on Cycle 3 Day 1 at 1 hour[± 15 minutes] after the end of 
magrolimab infusion). Residual samples used for PK and ADA analysis may also be used for 
explorato1y PK or PD analyses related to magrolimab treatment alone as well as combination 
therapy with anticancer chemotherapies. This could include using leftover senun for explorato1y, 
alternative PK assay development and analysis. 
6.3.12. 
Immunogenicity 
Peripheral blood for irmnunogenicity assessments for ADA against magrolimab will be collected 
as described in the schedule of assessments for patients who are assigned to receive magrolimab 
(Table 2 and Table 3). When collected on the day of study drng dosing, the blood sample for 
assessing ADA must be collected at the same time as the predose PK sample. The presence of 
ADA will be dete1mined by a validated chemiluminescence immunoassay method. 
6.3.13. 
Bio marker Testing 
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6.3.14. 
Patient-Reported Outcomes 
For the Randomized Cohort, 3 PRO instruments will be administered in this study: 
Final 
Amendment5 
EORTC-QLQ-C30, EQ-5D-5L, and the FCSI. The patient should complete these questionnaires 
before any other study procedmes conducted the same day at required visits. Please refer to 
Table 2 for timings of PRO assessments. If the PRO questionnaires are unavailable in a patient's 
language, completion is not required. Patients with other baiTiers to questionnaire completion 
may be exempt from these assessments after discussion with the sponsor. 
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6.3.14.1.
EORTC-QLQ-C30
The EORTC-QLQ-C30 is a reliable and valid measure of PROs and has been widely used among 
patients with cancer (Appendix 8). The EORTC-QLQ-C30 includes 30 separate questions 
(items) resulting in 5 functional scales (physical functioning, role functioning, emotional 
functioning, cognitive functioning, and social functioning), 1 global health status scale, 
3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, 
insomnia, loss of appetite, constipation, diarrhea, and financial difficulties) {Fayers 2001}. The 
recall period is 1 week (past week). It will take about 11 minutes to complete.
6.3.14.2.
EQ-5D-5L
The EQ-5D-5L is an instrument for use as a measure of health outcome {EuroQol Research 
Foundation 2017}. The EQ-5D-5L consists of 2 sections: the EuroQol (5 dimensions) (EQ-5D) 
descriptive system and the EuroQol visual analogue scale (EQ-VAS). A sample is provided in 
Appendix 9.
The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight 
problems, moderate problems, severe problems, and extreme problems. The patient is asked to 
indicate his/her health state by ticking the box next to the most appropriate statement in each of 
the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for 
that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that 
describes the patient’s health state.
The EQ-VAS records the patient’s self-rated health on a vertical visual analogue scale, where the 
endpoints are labeled “the best health you can imagine” and “the worst health you can imagine.”
The EQ-VAS can used as a quantitative measure of health outcome that reflects the patient’s 
own judgment.
6.3.14.3.
FACT Colorectal Symptom Index
The FCSI is a well-validated PRO instrument as a set of brief, clinically relevant, colorectal 
cancer symptoms for assessing symptomatic response. It comprises the most important 
symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, 
swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. 
Its minimum important difference (MID) range from 1.5 to 3 has been published {Colwell 
2010}. 
The FCSI questionnaire is provided in Appendix 10.


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6.4. 
Assessments for Early Discontinuation From Study Treatment or From the 
Study 
If a patient discontinues study dosing ( eg, as a result of an AE), eve1y attempt should be made to 
keep the patient in the study and continue to perfo1m the required study-related follow-up and 
procedures (see Section 3.4). If this is not possible or acceptable to the patient or investigator, the 
patient may be withdrawn from the study. 
6.4.1. 
Assessments for Early Discontinuation From Study Treatment 
A patient who discontinues study drng early will be asked to return to the investigational site 
within 7 days of stopping study diug to attend an early study diug discontinuation visit for 
assessments and procedures specified in Table 3. 
6.5. 
Poststudy Care 
Upon withdi·awal from study treatment, patients will receive the care upon which they and their 
physicians agree. Patients will be followed for disease progression (if applicable), survival, and 
AEs. Poststudy treatment assessments are described in Table 3. 
6.6. 
Sample Storage 
The stored biological samples may be used by Gilead or its research partner for additional testing 
to provide supplemental data to answer questions that relate to the ma~ 
end of this 
study, these samples may be retained in storage by Gilead for a period- or per 
counti re uirements. Sam les will be stored in com liance with all a licable re ulations. I 
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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events and Serious Adverse Events
7.1.1.
Adverse Events
An AE is any untoward medical occurrence in a clinical study patient administered a study drug 
that does not necessarily have a causal relationship with the treatment. An AE can therefore be 
any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use 
of a study drug, whether or not the AE is considered related to the study drug. Adverse events 
may also include pretreatment or posttreatment complications that occur as a result of 
protocol-specified procedures or special situations (Section 7.1.3). 
An AE does not include the following:
•
Medical or surgical procedures such as surgery, endoscopy, tooth extraction, or transfusion. 
The condition that led to the procedure may be an AE and must be reported.
•
Preexisting diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen.
•
Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions).
•
Overdose without clinical sequelae (Section 7.1.3).
•
Any medical condition or clinically significant laboratory abnormality with an onset date 
before the informed consent form is signed and not related to a protocol-associated procedure 
is not an AE but rather considered to be preexisting and should be documented as medical 
history.
Preexisting events that increase in severity or change in nature after study drug initiation or 
during or as a consequence of participation in the clinical study will also be considered AEs.
7.1.2.
Serious Adverse Events
An SAE is defined as an event that, at any dose, results in the following:
•
Death.
•
A life-threatening situation. (Note: The term “life-threatening” in the definition of “serious” 
refers to an event in which the patient was at risk of death at the time of the event; it does not 
refer to an event that hypothetically might have caused death if it were more severe.)
•
In-patient hospitalization or prolongation of existing hospitalization.


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•
Persistent or significant disability/incapacity.
•
A congenital anomaly/birth defect.
•
A medically important event or reaction: such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the patient or may 
require intervention to prevent one of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is reportable under 
expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse. 
7.1.2.1.
Protocol-Specific Serious Adverse Event Definitions
Given progression of disease is one of the endpoints of the study, in order to maintain study 
integrity, the following events that are assessed as unrelated to study drug will not be considered 
AEs/SAEs:
•
Progression of disease
•
Deaths related to progression of disease
Events that are considered to represent progression of disease should not be recorded as 
AEs/SAEs unless it is assessed that study drugs contributed to disease progression. These data 
will be captured as efficacy assessment data only. If there is any uncertainty as to whether an 
event is due to disease progression, it should be reported as an AE/SAE.
Death that is attributed by the investigator as solely due to disease progression and that occurs 
during the protocol-specified AE reporting period should be recorded only on the death eCRF 
(ie, not collected as an SAE on the AE eCRF).
7.1.2.1.1.
Deaths Not Related to Disease Progression
All other deaths (ie, deaths that are not due to disease progression) occurring during the 
protocol-specified AE reporting period, regardless of attribution, will be recorded on the AE 
eCRF and reported within 24 hours of awareness and no later than the next business day.
When recording a death on the eCRF, the event or condition that is considered the primary cause 
of death should be the AE term, and the outcome should be death. A patient can only have 1 AE 
(SAE) with outcome of death and severity of Grade 5 (CTCAE Version 5).


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7.1.3.
Study Drugs and Gilead Concomitant Medications Special Situations 
Reports
Special situations reports (SSRs) include all reports of medication error, abuse, misuse, overdose, 
occupational exposure, drug interactions, exposure via breastfeeding, unexpected benefit, 
transmission of infectious agents via the product, counterfeit of falsified medicine, and 
pregnancy, regardless of an associated AE. 
Medication error is any unintentional error in the prescribing, dispensing, preparation for 
administration or administration of a study drug while the medication is in the control of a health 
care professional, patient, or consumer. Medication errors may be classified as a medication error 
without an AE (which includes situations of missed dose), medication error with an AE, 
intercepted medication error, or potential medication error.
Abuse is defined as persistent or sporadic intentional excessive use of a study drug by a patient.
Misuse is defined as any intentional and inappropriate use of a study drug that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a study 
drug given per administration or cumulatively that is above the maximum recommended dose as 
per protocol or in the product labeling (as it applies to the daily dose of the patient in question). 
In cases of a discrepancy in drug accountability, overdose will be established only when it is 
clear that the patient has taken the excess dose(s). Overdose cannot be established when the 
patient cannot account for the discrepancy, except in cases in which the investigator has reason 
to suspect that the patient has taken the additional dose(s).
Occupational exposure is defined as exposure to a study drug as a result of one’s professional or 
nonprofessional occupation.
Drug interaction is defined as any drug/drug, drug/food, or drug/alcohol interaction.
Unexpected benefit is defined as an unintended therapeutic effect where the results are judged to 
be desirable and beneficial. 
Transmission of infectious agents is defined as any suspected transmission of an infected agent 
through a Gilead study drug.
Counterfeit or falsified medicine is defined as any study drug with a false representation of (a) its 
identity, (b) its source, or (c) its history.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or qualified subinvestigator is responsible for assessing AEs and SAEs for 
causality and severity, and for final review and confirmation of accuracy of event information 
and assessments.


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7.2.1.
Assessment of Causality for Study Drugs/NIMPs and Procedures
The investigator or qualified subinvestigator is responsible for assessing the relationship for each 
study drug and noninvestigational medicinal product (NIMP)/AxMP using clinical judgment and 
the following considerations:
•
No: Evidence exists that the AE has an etiology other than the study drug. For SAEs, an 
alternative causality must be provided (eg, preexisting condition, underlying disease, 
intercurrent illness, concomitant medication).
•
Yes: There is reasonable possibility that the AE may have been caused by the study drug.
It should be emphasized that ineffective treatment should not be considered as causally related in 
the context of AE reporting. If the investigator feels that it is reasonably possible that one of the 
NIMPs/AxMPs caused an event, the attribution will be reported using the alternative causality 
section of the SAE report in the electronic data capture (EDC).
The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations:
•
No: Evidence exists that the AE has an etiology other than the study procedure.
•
Yes: The AE occurred as a result of protocol procedures (eg, venipuncture).
7.2.2.
Assessment of Severity 
The severity of AEs will be graded using the CTCAE Toxicity Grading Scale, Version 5.0. For 
each episode, the highest grade attained should be reported as defined in the Toxicity Grading 
Scale (Appendix 5).
7.3.
Investigator Reporting Requirements and Instructions
7.3.1.
Requirements for Collection Before Study Drug Initiation
After informed consent but before initiation of study drug, only SAEs related to 
protocol-mandated procedures are to be reported, using the applicable eCRFs.
7.3.2.
Adverse Events
Following initiation of study drug, collect all AEs, regardless of cause or relationship, until 
30 days after last administration of study drug and report the AEs on the eCRFs as instructed.
All AEs and clinically significant laboratory abnormalities should be followed until resolution or 
until the AE is stable, if possible. Gilead may request that certain AEs be followed beyond the 
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7.3.3.
Serious Adverse Events
All SAEs, regardless of cause or relationship, that occur after the initiation of the first dose of 
study drug and throughout the duration of the study, including the safety follow-up visit, must be 
reported on the applicable eCRFs and to Gilead Patient Safety (PS) as instructed below in this 
section. Only SAEs that are considered related to study procedures are to be reported during the 
screening period.
Any SAEs and deaths that occur within 30 days of the last dose of study drug (safety follow-up 
visit), regardless of causality, should also be reported. 
Investigators are not obligated to actively seek SAEs after the protocol-defined follow-up period; 
however, if the investigator learns of any SAEs that occur after the protocol-defined follow-up 
period has concluded and the event is deemed relevant to the use of study drug, the investigator 
should promptly document and report the event to Gilead PS.
Instructions for reporting SAEs are described in Section 7.4.1.
7.3.4.
Study Drug Special Situations Reports
All study drug SSRs that occur from study drug initiation and throughout the duration of the 
study, including the posttreatment follow-up visit, must be reported to Gilead PS (Section 7.4.2). 
Adverse events and SAEs resulting from SSRs must be reported in accordance with the AE and 
SAE reporting guidance (Section 7.4).
7.3.5.
Concomitant Medications Reports
7.3.5.1.
Gilead Concomitant Medications Special Situations Report
The SSRs involving a Gilead concomitant medication (not considered study drug), that occur 
after the patient first consents to participate in the study (ie, signing of the informed consent 
form) and throughout the duration of the study, including the posttreatment follow-up visit, must 
be reported to Gilead PS utilizing the paper SSR (Section 7.4.2.1).
7.3.5.2.
Non-Gilead Concomitant Medications Report
Special situations involving non-Gilead concomitant medications do not need to be reported on 
the SSR form; however, for special situations that result in AEs because of a non-Gilead 
concomitant medication, the AE should be reported on the AE eCRF. 
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
All clinical sequelae in relation to these SSRs will be reported as AEs or SAEs at the same time 
using the AE eCRF and/or the SAE eCRF. Details of the symptoms and signs, clinical 
management, and outcome will be reported, when available.


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7.4.
Reporting Process for Serious Adverse Events and Special Situations Reports
7.4.1.
Serious Adverse Event Reporting Process
For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be transmitted by email or fax when requested and applicable. 
Transmission of such documents should occur without personal patient identification, 
maintaining the traceability of a document to the patient identifiers.
Additional information may be requested to ensure the timely completion of accurate safety 
reports.
Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the patient’s eCRF and the SAE narrative section of the Safety Report 
Form eCRF.
7.4.1.1.
Electronic Serious Adverse Event Reporting Process
Site personnel will record all SAE data on the applicable eCRFs and from there transmit the SAE 
information to Gilead PS within 24 hours of the investigator’s knowledge of the event from the 
time of the informed consent form signature throughout the duration of the study, including the 
protocol-required posttreatment follow-up period. 
If for any reason it is not possible to record and transmit the SAE information electronically, 
record the SAE on the paper SAE reporting form and transmit within 24 hours to:
Gilead PS:
Email: 
or
Fax: 
If an SAE has been reported via a paper form because the eCRF database has been locked, no 
further action is necessary. If the database is not locked, any SAE reported via paper must be 
transcribed as soon as possible on the applicable eCRFs and transmitted to Gilead PS.
7.4.2.
Special Situations Reporting Process 
7.4.2.1.
Paper Special Situations Reporting Process for Study Drug
All special situations will be recorded on the SSR form and transmitted by emailing or faxing the 
report form within 24 hours of the investigator’s knowledge of the event to the attention of 
Gilead PS from study drug initiation throughout the duration of the study, including the 
protocol-required posttreatment follow-up period.
Gilead PS:
Email: 
or
Fax: 
PPD
PPD
PPD
PPD


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7.4.2.2.
Reporting Process for Gilead Concomitant Medications
Special situations that involve Gilead concomitant medications that are not considered study 
drug must be reported within 24 hours of the investigator’s knowledge of the event to Gilead PS 
utilizing the paper SSR form and transmitted to:
Gilead PS:
Email: 
or
Fax: 
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
Special situations involving non-Gilead concomitant medications do not need to be reported on 
the SSR form; however, special situations that result in AEs because of a non-Gilead 
concomitant medication, must be reported on the AE eCRF.
7.4.2.3.
Pregnancy Reporting Process
The investigator should report pregnancies in female patients that are identified after initiation of 
study drug and throughout the study, including the protocol-required posttreatment follow-up 
period, to Gilead PS within 24 hours of becoming aware of the pregnancy using the pregnancy 
report form. Contact details for transmitting the pregnancy report form are as follows:
Gilead PS:
Email: 
or
Fax: 
The pregnancy itself is not considered an AE, nor is an induced elective abortion to terminate a 
pregnancy without medical reasons.
All other premature terminations of pregnancy (eg, a spontaneous abortion, an induced 
therapeutic abortion because of complications or other medical reasons) must be reported within 
24 hours as an SAE, as described in Section 7.4.1. The underlying medical reason for this 
procedure should be recorded as the AE term.
A spontaneous abortion is always considered to be an SAE and will be reported as described in 
Section 7.4.1. Furthermore, any SAE occurring as an adverse pregnancy outcome after the study 
must be reported to Gilead PS.
The patient should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome of the pregnancy should be reported to Gilead PS using the pregnancy 
outcome report form. If the end of the pregnancy occurs after the study has been completed, the 
outcome should be reported directly to Gilead PS. Gilead PS contact information is as follows: 
email:
 and fax:
.
PPD
PPD
PPD
PPD
PPD
PPD


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Refer to Appendix 4 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Requirements.
7.5.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA CFR, 
the EU Clinical Trials Directive (2001/20/EC) and relevant updates, and other country-specific 
legislation or regulations, Gilead may be required to expedite to worldwide regulatory agencies 
reports of SAEs, which may be in the form of listings, serious adverse drug reactions, or 
suspected unexpected serious adverse reactions. In accordance with the EU Clinical Trials 
Directive (2001/20/EC), Gilead or a specified designee will notify worldwide regulatory 
agencies and the relevant IEC in concerned Member States of applicable suspected unexpected 
serious adverse reactions as outlined in current regulations.
Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the IB or relevant local label as applicable. 
All investigators will receive a safety letter notifying them of relevant suspected unexpected 
serious adverse reaction reports associated with any study drug. The investigator should notify 
the IRB or IEC of suspected unexpected serious adverse reaction reports as soon as is practical, 
where this is required by local regulatory agencies, and in accordance with the local institutional 
policy. 
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not to be recorded as AEs or SAEs. 
However, laboratory abnormalities (eg, clinical chemistry, hematology, urinalysis) that require 
medical or surgical intervention or lead to study drug interruption, modification, or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, ECG, x-rays, vital signs) that are associated with 
signs and/or symptoms must be recorded as an AE or SAE if they meet the definition of an AE 
or SAE as described in Sections 7.1.1 and 7.1.2. If the laboratory abnormality is part of a 
syndrome, record the syndrome or diagnosis (eg, anemia), not the laboratory result (ie, decreased 
Hb).
Severity should be recorded and graded according to the CTCAE Toxicity Grading Scale, 
Version 5.0 (Appendix 5). For AEs associated with laboratory abnormalities, the event should be 
graded on the basis of the clinical severity in the context of the underlying conditions; this may 
or may not be in agreement with the grading of the laboratory abnormality.
7.7.
Abnormal Liver Function Tests
Liver toxicity will be evaluated for all patients.


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In the absence of an explanation for increased liver function tests, such as viral hepatitis, 
preexisting or acute liver disease, or exposure to other agents associated with liver injmy , the 
patient may be discontinued from the study treatment if the investigator detennines that it is not 
in the patient's best interest to continue. Discontinuation of treatment should be considered if 
there is an indication of severe liver injmy according to Hy's Law, defined by FDA Guidance for 
Industiy, Drng-Induced Liver Injmy: Premarketing Clinical Evaluation {U.S. Department of 
Health and Human Services 2009}, as: 
• 
Treatment-emergent ALT or AST elevation(~ 3 x ULN), and 
• 
Treatment-emergent total bilirnbin elevation (> 2 x ULN), and absence of cholestasis 
( defined as alkaline phosphatase < 2 x ULN), and 
• 
No other good explanation for the injmy (hepatitis A, B, C, or other viral hepatic injmy, 
alcohol ingestion, congestive heaii failure, worsening liver metastases, hemolysis). 
7.8. 
7.8.1. 
Toxicity Management 
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Bevacizumab, 5-fluorouracil, lrinotecan, and Leucovorin/Levoleucovorin 
Refer to bevacizumab, 5-FU, irinotecan, LV, and levoleucovorin local prescribing info1mation 
( eg, summaiy of product characteristics, US prescribing info1mation) and local guidelines for 
safety management. 
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Additional details for the planned analyses will be provided in the statistical analysis plan (SAP) 
including any deviations from the original statistical analyses planned. 
8.1. 
Analysis Objectives and Endpoints 
The objectives and endpoints are provided in Section 2. 
8.2. 
Planned Analyses 
8.2.1. 
Dose Determination Analysis 
For the pm-pose of making the dose de-escalation decisions the Safety Run-in Coho1t, dose 
determination analyses of relevant safety data focusing on DLTs and overall safety profile will 
be conducted by the sponsor after all patients have completed the required DLT-assessment 
period as specified in Section 3 .1.1. Safety assessments ( eg, AEs, ECG, laborato1y test results) 
will be displayed by coho1t to facilitate the dose de-escalation decisions. 
8.2.2. 
Primary Analysis 
For the primaiy analysis, outstanding data queries will have been resolved or ad'udicated as 
unresolvable, and the data will have been cleaned and finalized for the anal sis. 
8.2.3. 
Final Analysis 
The final analysis will be perfonned after all patients have completed the study or discontinued 
eai·ly, outstanding data queries have been resolved or adjudicated as unresolvable, and the data 
have been cleaned and finalized. 
8.3. 
8.3.1. 
8.3.1.1. 
8.3.1.1.1. 
Analysis Conventions 
Analysis Sets 
Efficacy 
Safety Run-in Coho1t 
For the Safety Run-in Coho1t, the primaiy analysis set for efficacy analysis is the modified 
Intent-to-Treat (ITT) Analysis Set, defined as all patients who received at least 1 dose of any 
study diug. 
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8.3.1.1.2.
Randomized Cohort
For the Randomized Cohort, the primary analysis set for efficacy analysis is the ITT Analysis 
Set, defined as all randomized patients according to the treatment arm to which the patients are 
randomized, unless otherwise specified.
8.3.1.2.
Safety
8.3.1.2.1.
DLT-Evaluable Analysis Set
For the Safety Run-in Cohort, the primary analysis set for the DLT analysis is the 
DLT-Evaluable Analysis Set, defined as all patients who meet one of the following criteria in the 
DLT-evaluable period (defined as the first 28 days): 
•
Patient experienced a DLT at any time after initiation of the first infusion of magrolimab.
•
Patient did not experience a DLT and completes at least 3 infusions of magrolimab and at 
least 2 doses of bevacizumab and FOLFIRI in the Safety Run-in Cohort.
8.3.1.2.2.
Safety Run-in Cohort
For the Safety Run-in Cohort, the primary analysis set for safety analysis, except for DLTs, is the 
Safety Analysis Set, defined as all patients who received at least 1 dose of any study drug.
8.3.1.2.3.
Randomized Cohort
For the Randomized Cohort, the primary analysis set for safety analyses is the Safety Analysis 
Set, defined as all randomized patients who received at least 1 dose of any study drug, with 
treatment assignment designated according to the actual treatment received.
8.3.1.3.
Pharmacokinetics
The PK analysis will be conducted on the PK Analysis Set, defined as all patients who received 
any amount of magrolimab and have at least 1 measurable posttreatment serum concentration of 
magrolimab.
8.3.1.4.
Immunogenicity
The immunogenicity analysis will be conducted on the Immunogenicity Analysis Set, defined as 
all patients who received any amount of magrolimab and have at least 1 evaluable ADA test 
result.
8.3.1.5.
Biomarkers
The biomarker analysis will be conducted on the Biomarker Analysis Set, defined as all patients 
who received any study drug and have at least 1 evaluable biomarker measurement available.


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Data Handling Conventions 
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By-patient listings will be created for important variables from each eCRF module. Summaiy 
tables for continuous vai·iables will contain the following statistics: N (number in analysis set), 
n (number with data), mean, SD, 95% Cls on the mean, median, minimum, and maximum. 
Summa1y tables for categorical variables will include: N, n, percentage, and 95% Cls on the 
percentage. Unless othe1w ise indicated, 95% Cls for bina1y vai·iables will be calculated using the 
binomial distribution ( exact method) and will be 2-sided. Data will be described and summai·ized 
by treatment aim. 
The baseline value used in each analysis will be the last (most recent) pretreatment value before 
or on the first dosing date of study treatment. As appropriate, changes from baseline to each 
subsequent time point will be described and sUilllnai·ized. Graphical techniques (ie, waterfall 
plots, Kaplan-Meier [KM] curves, line plots) may be used when such methods ai·e appropriate 
and infonnative. Analyses will be based upon the observed data unless methods for handling 
missing data are specified. If there is a significant degree of nonnonnality, analyses may be 
perfo1med on log-transfonned data or nonparametric tests may be applied, as appropriate. 
8.4. 
Demographic and Baseline Characteristics Analysis 
Demographic and baseline measurements will be sUilllnai-ized using standai·d descriptive 
methods. Demographic smnmai·ies will include sex, race/ethnicity, and age. Baseline data will 
include a sUilllnaiy of body weight, height, body mass index, selected laborato1y data, medical 
and cancer histo1y, prior treatment and number of prior treatment(s), tumor imaging for baseline 
response assessment, randomization stratification group, and ECOG perfo1mance status. 
8.5. 
8.5.1. 
8.5.1.1. 
Efficacy Analysis 
Primary Efficacy Endpoint Analysis 
Randomized Coho1t 
For the Randomized Coho1t, PFS by investigator assessment will be analyzed using KM 
methods. Patients who did not have documented disease progression or death will be censored at 
the date of their last response assessment during the study with documentation of no disease 
progression. The KM estimate of the survival function will be computed, and the results will be 
presented using KM curves. The median will be provided along with the conesponding 95% CI. 
A log-rank test stratified by the randomization factors will be used to compai·e treatment 
difference in PFS. A stratified Cox propo1tional hazai·d regression model will be used to estimate 
the HR and its 2-sided 95% CI. 
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8.5.2.
Secondary Efficacy Endpoint Analyses
Analysis of OS and DOR will be similar to that of the primary endpoint analysis of PFS for the 
Randomized Cohort.
Confirmed ORR by investigator assessment will be summarized by count and percentage of 
patients. A Cochran-Mantel-Haenszel (CMH) chi-square test for association between treatment 
and response, after adjusting for stratification factors, will be performed to compare the 
2 treatment arms. Patients who do not have sufficient baseline or on-study tumor assessment to 
characterize response will be counted as nonresponders. Odds ratios and corresponding 95% CIs 
will also be presented.
8.6.
Safety Analysis
8.6.1.
Primary Safety Endpoint Analysis
For the Safety Run-in Cohort, the incidence of DLTs, AEs, and laboratory abnormalities during 
the DLT-assessment period by count and percentage will be reported using the DLT-Evaluable 
Analysis Set. The DLT-assessment period is defined as the first 28 days of dosing.
8.6.2.
Other Safety Analysis
All safety data collected on or after the date that study drug was first dispensed up to the date of 
last dose of study drug plus 30 days or the day before initiation of subsequent anticancer therapy, 
whichever comes first, will be summarized by treatment arm (according to the study drug 
received). Data for the pretreatment and treatment-free safety follow-up periods will be included 
in data listings. For categorical safety data, including incidence of AEs and categorizations of 
laboratory data, counts and percentages of patients will be summarized. For continuous safety 
data, including laboratory data, number of patients, mean, SD, minimum, quartiles, median, and 
maximum will be summarized.
8.6.3.
Extent of Exposure
Data regarding a patient’s extent of exposure to study drug will be generated from the study drug 
administration data. Exposure data will be summarized by treatment arm. 
8.6.4.
Adverse Events
Clinical and laboratory AEs will be coded using the current version of the MedDRA. System 
organ class, high-level group term, high-level term, preferred term, and lower-level term will be 
attached to the clinical database.
Events will be summarized on the basis of the date of onset for the event. A treatment-emergent 
AE will be defined as any AE that begins on or after the date of first dose of study drug up to the 
date of last dose of study treatment plus 30 days or the day before initiation of subsequent 
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Summaries (number and percentage of patients) of treatment-emergent AEs (by system organ 
class, and prefe1Ted te1m) will be provided by treatment aim. 
8.6.5. 
Laboratory Evaluations 
Selected laborato1y test data (using conventional units) will be summarized using only observed 
data. 
Graded laborato1y abno1malities will be defined using the grading scheme in Appendix 5. 
Incidence of treatment-emergent laborato1y abnonnalities, defined as values that increase at least 
1 toxicity grade after the date of first dose of study dmg up to the date of last dose of study 
treatment plus 30 days or the day before initiation of subsequent anticancer therapy, whichever 
comes first, will be summarized by treatment aim. If baseline data are Inissing, then any graded 
abno1mality (ie, at least a Grade 1) will be considered treatment emergent. 
Laborato1y abnonnalities that occm before the first dose of study diug or after the patient has 
been discontinued from treatment for at least 30 days will be included in a data listing. 
8.6.6. 
Other Safety Evaluations 
Vital signs and physical examination findings will be summarized by treatment aim. Details will 
be provided in the SAP. 
8.7. 
Pharmacokinetic Analysis 
The PK Analysis Set will be used for sUilllllai·ies of PK concentration of magrolimab versus time. 
Semm concentrations will be listed and summarized for magrolimab using descriptive statistics 
by sainpling time point and dose level. Graphical plots of individual semm concentration versus 
time and mean concentration versus time by dose level will be generated. All data from this 
study may be combined with PK data from other company sponsored clinical studies and 
analyzed using a population PK model. Such an analysis would be repo1ied separately. 
8.8. 
Immunogenicity Analysis 
Irnmunogenicity will be assessed using a 3-tier (screen, confnmato1y, and titer) approach on 
semm samples. The rate of ADA incidence and prevalence will be sUilllllai·ized for the 
Irnmunogenicity Analysis Set. Titer and neutralizing antibodies will be dete1mined and repo1ied 
for ADA positive sainples only. Titer data will be listed and neutralizing antibodies will be 
tabulated by visit and dose level. Explorato1y evaluations may be conducted to dete1mine the 
relationship between ADA positivity and safety, PK, or efficacy pai·aineters (eg, diug 
concentrations, AEs, disease response) using graphical, tabulai·, and population PK approaches. 
8.9. 
Biomarker Analysis 
The baseline level, absolute level, and change from baseline level over time will be summarized 
using descriptive statistics for each biomai·ker at sain le collection time oint b treatment aim, 
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Analysis of Patient-Reported Outcome Data 
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Summaiy statistics and the mean change from baseline of lineai·-transfonned scores will be 
repo1ied for all of the items and subscales of the EORTC-QLQ-C30, EQ-5D-5L, and FCSI 
questionnaires at each time point. In addition, mean scores for global health status, physical 
functioning, and selected symptom scales will be presented. The scores will be derived according 
to the scoring manual guidelines. The MID-based response rate, time to response, DOR, and time 
to deterioration will be analyzed like the efficacy endpoints. 
8.11. 
Sample Size 
8.12. 
Gilead Data Review Committee 
An internal GDRC will be established to monitor the safety of patients in Randomized Coho1i 
Ann A. The GDRC will perfonn interim reviews of safety data and assess any treatment-related 
toxicities per the prespecified stopping rnles described in Section 3 .1.2.1. The GDRC 's specific 
activities as well as the GDRC's membership, conduct, and meeting schedule will be defined in 
the GDRC chaiter. 
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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with International Council 
for Harmonisation (ICH) E6(R2) addendum to its guideline for GCP and applicable laws and 
regulations.
9.1.2.
Financial Disclosure
The investigator and subinvestigators will provide prompt and accurate documentation of their 
financial interest or arrangements with the sponsor or proprietary interests in the study drug. This 
documentation must be provided before the investigator’s (and any subinvestigator’s) 
participation in the study. The investigator and subinvestigator agree to notify Gilead of any 
change in reportable interests during the study and for 1 year following completion of the study. 
Study completion is defined as the date when the last patient completes the protocol-defined 
activities.
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval
The investigator (or Gilead as appropriate according to local regulations) will submit this 
protocol, informed consent form, and any accompanying material to be provided to the patient 
(such as advertisements, patient information sheets, or descriptions of the study used to obtain 
informed consent) to an IRB/IEC. The investigator will not begin any study patient activities 
until approval from the IRB/IEC has been documented and provided as a letter to the 
investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC any modifications made to the protocol or any accompanying material to be 
provided to the patient after initial IRB/IEC approval, with the exception of those necessary to 
reduce immediate risk to study patients.
9.1.4.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study before undertaking any study-related procedures. The investigator 
must use the most current IRB/IEC-approved informed consent form for documenting written 
informed consent. Each informed consent form (or assent as applicable) will be appropriately 
signed and dated by the patient or the patient’s legally authorized representative, the person 
conducting the consent discussion, and an impartial witness (if required by IRB/IEC or local 
requirements). 


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The informed consent form will inform patients about genomic testing and/or planned sample 
retention. In addition to the study-specific informed consent form to be signed by each patient 
participating in the study, patients will be required to document additional consent to provide 
additional samples and/or to allow the use of the remainder of their already-collected specimens 
for optional future research, in accordance with applicable regulations. The results of the tests 
performed on the samples will not be given to the patient or the investigator. The stored 
biological samples will be destroyed no later than 15 years after the end of study or per country 
requirements, but patients may at any time request that their stored samples be destroyed.
9.1.5.
Confidentiality
The investigator must ensure that patients’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only an identification code and any other 
unique identifier(s) as allowed by local law (such as year of birth) will be recorded on any form 
or biological sample submitted to Gilead, IRB/IEC, or the laboratory. Laboratory specimens 
must be labeled in such a way as to protect patient identity while allowing the results to be 
recorded to the proper patient. Refer to specific laboratory instructions. Note: the investigator 
must keep a screening log with details for all patients screened and enrolled in the study, in 
accordance with the site procedures and regulations. Patient data will be processed in accordance 
with all applicable regulations.
The investigator agrees that all information received from Gilead, including but not limited to the 
IB, this protocol, eCRFs, study drug information, and any other study information, remains the 
sole and exclusive property of Gilead during the conduct of the study and thereafter. This 
information is not to be disclosed to any third party (except employees or agents directly 
involved in the conduct of the study or as required by law) without prior written consent from 
Gilead. The investigator further agrees to take all reasonable precautions to prevent the 
disclosure by any employee or agent of the investigational site to any third party or otherwise 
into the public domain.
9.1.6.
Study Files and Retention of Records
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following 2 categories: (1) investigator’s study file and (2) patient 
clinical source documents.
The investigator’s study file will contain the protocol/amendments, eCRFs, IRB/IEC, and 
governmental approval with correspondence, the informed consent form(s), drug records, staff 
curriculum vitae and authorization forms, and other appropriate documents and correspondence.
The required source data should include sequential notes containing at least the following 
information for each patient:
•
Patient identification
•
Documentation that the patient meets eligibility criteria (ie, medical history, physical 
examination, and confirmation of diagnosis [to support inclusion and exclusion criteria])


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•
Documentation of the reason(s) a consented patient is not enrolled
•
Participation in study (including study number)
•
Study discussed and date of informed consent
•
Dates of all visits
•
Documentation that protocol-specific procedures were performed
•
Results of efficacy parameters, as required by the protocol
•
Start and end date (including dose regimen) of study drug, including dates of dispensing and 
return
•
Record of all AEs and other safety parameters (start and end date; causality and severity) and 
documentation that adequate medical care has been provided for any AE
•
Concomitant medication (start and end date; dose if relevant; dose changes)
•
Date of study completion and reason for early discontinuation, if it occurs
All clinical study documents must be retained by the investigator for at least 2 years or according 
to local laws, whichever is longer, after the last approval of a marketing application in an ICH 
region (ie, the US, Europe, or Japan) and until there are no pending or planned marketing 
applications in an ICH region; or, if no application is filed or if the application is not approved 
for such indication, for 2 years after the investigation is discontinued and regulatory authorities 
have been notified. Investigators may be required to retain documents longer if specified by 
regulatory requirements, by local regulations, or by an agreement with Gilead. The investigator 
must notify Gilead before destroying any clinical study records.
Should the investigator wish to assign the study records to another party or move them to another 
location, Gilead must be notified in advance.
If the investigator cannot provide for this archiving requirement at the investigational site for any 
or all of the documents, special arrangements must be made between the investigator and Gilead 
to store these records securely away from the site so that they can be returned sealed to the 
investigator in case of an inspection. When source documents are required for the continued care 
of the patient, appropriate copies should be made for storage away from the site.
9.1.7.
Case Report Forms
An eCRF casebook will be completed by an authorized study personnel member whose training 
for this function is completed in the EDC system unless otherwise directed. The eCRF casebook 
will only capture the data required per the protocol schedule of events and procedures, unless 
collected by a non-EDC vendor system (eg, central laboratory). The Inclusion/Exclusion Criteria 
and Enrollment eCRFs should be completed only after all data related to eligibility are available. 
Data entry should be performed in accordance with the case report form Completion Guidelines 


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provided by the sponsor. Subsequent to data entry, a study monitor may perform source data 
verification. System-generated or manual queries will be issued in the EDC system as data 
discrepancies are identified by the study monitor or Gilead personnel who routinely review the 
data for completeness, correctness, and consistency. The site investigator, site coordinator, or 
other designee is responsible for responding to the queries in a timely manner, within the system, 
either by confirming the data as correct or updating the original entry, and providing the reason 
for the update (eg, data entry error). Original entries as well as any changes to data fields will be 
stored in the audit trail of the system. Regular oversight by the principal investigator of the data 
entered into the EDC system is expected to occur on an ongoing basis throughout the study to 
ensure quality and completeness. At a minimum, before any interim, final, or other time points 
(as instructed by Gilead), the investigator apply his/her electronic signature to confirm that the 
forms have been reviewed and that the entries accurately reflect the information in the source 
documents. At the conclusion of the study, Gilead will provide the site investigator with a read-
only archive copy of the data entered. This archive must be stored in accordance with the records 
retention requirements outlined in Section 9.1.6.
9.1.8.
Investigator Inspections
The investigator will make available all source documents and other records for this study to 
Gilead’s appointed study monitors, to IRB/IEC, or to regulatory authority or health authority 
inspectors.
9.1.9.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.
9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications, except those intended to reduce immediate risk to study patients, may be 
made only by Gilead. The investigator must submit all protocol modifications to the IRB/IEC in 
accordance with local requirements and receive documented IRB/IEC approval before 
modifications can be implemented.
9.2.2.
Study Reports and Publications
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies) when 
applicable and in accordance with local regulatory requirements. Gilead will ensure that the 
report meets the standards set out in the ICH Guideline for Structure and Content of Clinical 
Study Reports (ICH E3). Note that an abbreviated report may be prepared in certain cases. For 
studies with sites in countries following the EU Regulation No. 536/2014, a CSR will be 
submitted within 1 year (6 months for pediatric studies, in accordance with Regulation 
[European Commission] No. 1901/2006) after the global end of study (as defined in 
Section 3.5.2).


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Investigators in this study may communicate, orally present, or publish study data in scientific 
journals or other scholarly media in accordance with the Gilead clinical trial agreement.
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study personnel may be asked to provide services performed under this 
protocol (eg, attendance at investigator meetings). If required under the applicable statutory and 
regulatory requirements, Gilead will capture and disclose to federal and state agencies any 
expenses paid or reimbursed for such services, including any clinical study payments, meal 
and/or travel expenses or reimbursements, consulting fees, and any other transfer of value.
9.3.2.
Access to Information for Monitoring
In accordance with regulations and guidelines, the study monitor must have direct access to the 
investigator’s source documentation and any patient records in order to verify the adherence to 
the protocol and the accuracy of the data recorded in the eCRF. The study monitor is responsible 
for routine review of the case report form/eCRF form at regular intervals throughout the study to 
verify adherence to the protocol and the completeness, consistency, and accuracy of the data 
being entered on them. The investigator agrees to cooperate with the study monitor to ensure that 
any problems detected through any type of monitoring (central, off-site, on-site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or Gilead may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority, the 
investigator agrees to notify the Gilead study monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
Study Discontinuation
Both Gilead and the investigator reserve the right to terminate the study at any time. Should this 
be necessary, both parties will arrange discontinuation procedures and notify the patients, 
appropriate regulatory authority(ies), and IRB/IEC. In terminating the study, Gilead and the 
investigator will ensure that adequate consideration is given to the protection of the patients’ 
interests.


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10.
REFERENCES
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Allegra CJ, Jessup JM, Somerfield MR, Hamilton SR, Hammond EH, Hayes DF, et al. American 
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Bennouna J, Sastre J, Arnold D, Osterlund P, Greil R, Van Cutsem E, et al. Continuation of 
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Brahmer J, Lacchetti C, Schneider B, Atkins M, Brassil K, Caterino J, et al. Management of 
Immune-Related Adverse Events in Patients Treated With Immune Checkpoint 
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Guideline. Journal of clinical Oncology 2018;36 (17).
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: 
GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 
185 countries. CA Cancer J Clin 2018;68 (6):394-424.
CAMPTOSAR, Pharmacia and Upjohn Co. CAMPTOSAR® (irinotecan) injection, for 
intravenous use. U.S. Prescribing Information. NY, NY. Revised January.  2020:
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developing cancer. Nat Rev Cancer. 2012;12 (1):58-67.
Chen JY, McKenna KM, Choi TS, Duan J, Brown L, Stewart JJ, et al. RBC-Specific CD47 
Pruning Confers Protection and Underlies the Transient Anemia in Patients 
Treated with Anti-CD47 Antibody 5F9 [Abstract]. Blood (ASH Annual Meeting 
Abstracts) 2018;132 (Suppl 1):2327.
Colwell H, Mathias S, Turner M, Lu J, Wright N, Peeters M, et al. Psychometric Evaluation of 
the FACT Colorectal Cancer Symptom Index (FCSI-9): Reliability, Validity, 
Responsiveness, and Clinical Meaningfulness. The Oncologist 2010.
Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet 2019;394 
(10207):1467-80.


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Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New Response 
Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (Version 1.1). 
Eur J Cancer 2009;45 (2):228-47.
Erber R, Thurnher A, Katsen AD, Groth G, Kerger H, Hammes HP, et al. Combined inhibition 
of VEGF and PDGF signaling enforces tumor vessel regression by interfering 
with pericyte-mediated endothelial cell survival mechanisms. FASEB J 2004;18 
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instruments/eq-5d-5l-about/. Accessed: 10 August 2020. Last Updated: 18 April.  
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Fayers PM. Interpreting quality of life data: population-based reference data for the EORTC 
QLQ-C30. Eur J Cancer 2001;37 (11):1331-4.
Ferrara N. Vascular endothelial growth factor: basic science and clinical progress. Endocrine 
reviews 2004;25 (4):581-611.
FLUOROURACIL, Spectrum Pharmaceuticals I. FLUOROURACIL injection, for intravenous 
use. U.S Prescribing Information. Irvine, CA. Revised July.  2016:
Gerber HP, Ferrara N. Pharmacology and pharmacodynamics of bevacizumab as monotherapy or 
in combination with cytotoxic therapy in preclinical studies. Cancer Res 2005;65 
(3):671-80.
Giantonio BJ, Catalano PJ, Meropol NJ, O'Dwyer PJ, Mitchell EP, Alberts SR, et al. 
Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin 
(FOLFOX4) for previously treated metastatic colorectal cancer: results from the 
Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007;25 
(12):1539-44.
Grothey A, Sargent D, Goldberg RM, Schmoll HJ. Survival of patients with advanced colorectal 
cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and 
oxaliplatin in the course of treatment. J Clin Oncol 2004;22 (7):1209-14.
Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, et al. 
Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic 
colorectal cancer. N Engl J Med 2004;350 (23):2335-42.
Ivanova A, Qaqish BF, Schell MJ. Continuous toxicity monitoring in phase II trials in oncology. 
Biometrics 2005;61 (2):540-5.
Jaiswal S, Jamieson CH, Pang WW, Park CY, Chao MP, Majeti R, et al. CD47 Is Up-Regulated 
on Circulating Hematopoietic Stem Cells and Leukemia Cells to Avoid 
Phagocytosis. Cell 2009;138 (2):271-85.


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Le DT, Uram JN, Wang H, Bartlett BR, Kemberling H, Eyring AD, et al. PD-1 Blockade in 
Tumors with Mismatch-Repair Deficiency. N Engl J Med 2015;372 (26):2509-20.
Lee MS, Kopetz S. Current and Future Approaches to Target the Epidermal Growth Factor 
Receptor and Its Downstream Signaling in Metastatic Colorectal Cancer. Clin 
Colorectal Cancer 2015;14 (4):203-18.
LEUCOVORIN, Ben Venue Laboratories I. Leucovorin Calcium Injection USP Leucovorin 
Calcium for Injection. U.S. Prescribing Information. Revised November.  2011:
LEVOLEUCOVORIN, Actavis Pharma I. LEVOLEUCOVORIN for injection, for intravenous 
use. U.S. Prescribing Information. Italy. Revised September.  2016:
Liu J, Wang L, Zhao F, Tseng S, Narayanan C, Shura L, et al. Pre-Clinical Development of a 
Humanized Anti-CD47 Antibody with Anti-Cancer Therapeutic Potential. PLoS 
One. 2015;10 (9):e0137345.
Majeti R, Chao MP, Alizadeh AA, Pang WW, Jaiswal S, Gibbs KD, Jr., et al. CD47 Is an 
Adverse Prognostic Factor and Therapeutic Antibody Target on Human Acute 
Myeloid Leukemia Stem Cells. Cell 2009;138 (2):286-99.
Masi G, Loupakis F, Salvatore L, Cremolini L, Fornaro L, Schirripa M, et al. A randomized 
phase III study evaluating the continuation of bevacizumab (BV) beyond 
progression in metastatic colorectal cancer (MCRC) patients (PTS) who received 
bv as part of first-line treatment: results of the bebyp trial by the gruppo 
oncologico nord ovest (GONO) [Abstract LBA17].  Annals of Oncology  2012:
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and 
response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 
1982;5 (6):649-55.
Overman MJ, Kopetz S, McDermott RS, Leach J, Lonardi S, Lenz HJ, et al. Nivolumab ± 
ipilimumab in treatment (tx) of patients (pts) with metastatic colorectal cancer 
(mCRC) with and without high microsatellite instability (MSIH): CheckMate-142 
interim results [Abstract 3501]. American Society of Clinical Oncology (ASCO) 
Annual Meeting; 2016 03-07 June; Chicago, Illinois. 
Pozzi C, Cuomo A, Spadoni I, Magni E, Silvola A, Conte A, et al. The EGFR-specific antibody 
cetuximab combined with chemotherapy triggers immunogenic cell death. Nat 
Med 2016;22 (6):624-31.
Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, et al. Bevacizumab in 
Combination With Oxaliplatin-Based Chemotherapy As First-Line Therapy in 
Metastatic Colorectal Cancer: A Randomized Phase III Study. J Clin Oncol 
2008;26 (12):2013-9.


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Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin 2018;68 (1):7-30.
Sikic BI, Lakhani N, Patnaik A, Shah SA, Chandana SR, Rasco D, et al. First-in-Human, First-
in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With 
Advanced Cancers. J Clin Oncol 2019;37 (12):946-53.
Cancer Stat Facts: Colorectal Cancer. Available at: 
https://seer.cancer.gov/statfacts/html/colorect.html. Accessed 29 June, 2021.
Tebbutt NC, Wilson K, Gebski VJ, Cummins MM, Zannino D, van Hazel GA, et al. 
Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic 
colorectal cancer: results of the Australasian Gastrointestinal Trials Group 
Randomized Phase III MAX Study. J Clin Oncol 2010;28 (19):3191-8.
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Followed by FOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer: 
A Randomized GERCOR Study. J Clin Oncol 2004;22 (2):229-37.
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Platelet Concentrate to Resolve Interference of Anti-CD47 in Serologic Testing 
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Monoclonal anti-CD47 interference in red cell and platelet testing. Transfusion 
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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Magrolimab Repriming Administration and Associated Assessment Schedule
Appendix 3.
Pandemic Risk Assessment and Mitigation Plan
Appendix 4.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements
Appendix 5.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities
Appendix 6.
Eastern Cooperative Oncology Group (ECOG) Performance Status
Appendix 7.
Response Evaluation Criteria in Solid Tumors (RECIST V1.1)
Appendix 8.
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire – Core Questionnaire (EORTC QLQ-C30)
Appendix 9.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
Appendix 10.
FACT Colorectal Symptom Index (FCSI)
Appendix 11.
Authorization Status of Study Interventions
Appendix 12.
Country-Specific Requirements
Appendix 13.
Amendment History
Appendix 14.
Sponsor Signature Page


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Appendix 1.
Investigator Signature Page
GILEAD SCIENCES, INC.
333 LAKESIDE DRIVE
FOSTER CITY, CA 94404
A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in 
Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously 
Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
GS-US-587-6156, Amendment 5, 31 October 2023
CLINICAL STUDY PROTOCOL ACKNOWLEDGMENT
INVESTIGATOR STATEMENT
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated.
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Gilead Sciences, Inc. I will discuss this material with them to ensure 
that they are fully informed about the drugs and the study.
Principal Investigator Name (Printed)
Signature
Date
Site Number


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Appendix 2. 
Magrolimab Repriming Administration and Associated Assessment Schedule 
Appendix Table 1. 
Magrolimab Repriming Administration and Associated Assessment Schedule 
Visit Window (Days)• 
Cycle Dayb 
Safety 
CBC with differential, platelets, reticulocytesc, d 
Chemistry" 
Vital signs and weigh~ 
Symptom-directed physical examination° 
Pregnancy testf 
Adverse eventsg 
Concomitant medicationsg 
Magrolimab Administration 
Premedicationh 
Magrolimabi 
a I' 
I 
I 
I 
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h
Premedication for magrolimab is required prior to the administration of the first 4 doses of study treatment in case of reintroduction with repriming. Premedication after the 
first 4 doses may be continued based on the treating physician’s clinical judgment and the presence/severity of prior infusion-related reactions. In the case of a Grade 3 
infusion-related reaction, a premedication regimen for subsequent doses is required (Section 5.5.3).
i
Magrolimab should not be given on consecutive days. The duration of infusion including flush will be 3 hours (± 30 minutes) for the first dose of magrolimab, and then 
2 hours (± 30 minutes) for subsequent infusions. Monitor patients for 1 hour postinfusion, during first 4 weeks for repriming. For magrolimab dosing, please refer to Table 6. 
If repriming occurs at Cycle 3 onwards, Q2W dosing will begin at this time point.


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Appendix 3.
Pandemic Risk Assessment and Mitigation Plan
During an ongoing pandemic, potential risks associated with patients being unable to attend 
study visits have been identified for this study. 
These potential risks and mitigation plans can be summarized as follows:
1) Schedule of assessments:
a) Physical examination:
i)
In order to limit a patient’s time in the clinic, a virtual visit may be conducted for the 
physical examination assessment. Vital signs may be omitted for virtual visits. 
However, dosing and biological sample collection should occur per protocol in the 
clinic.
b) Dosing:
i)
Patients may be unable to return to the site for a number of visits to receive the study 
drug, or the site may be unable to accept any patient visits. Without study drugs, the 
patient would not be able to stay on the study drug as planned per protocol.
Mitigation plan: If permitted by local ethics committee/institutional review boards 
noninvestigational product as determined by sponsor (ie, docetaxel) can be administered 
at a clinic closer to the patient, under the supervision of a licensed physician. If 
necessary, a dosing delay for magrolimab must be discussed with the sponsor in this 
instance. A virtual study visit, via phone or video conferencing, must be performed prior 
to remote dosing. At the earliest opportunity, the site will schedule in-person patient 
visits and return to the protocol’s regular schedule of assessments. A qualified courier 
may be considered to ship the drug from sites to the alternate clinic.
c) General patient selection guidance:
i)
To minimize patients receiving red blood cell transfusions, we recommend selecting 
patients with higher hemoglobin thresholds at baseline and use intravenous iron 
and/or erythropoietin where clinically indicated.
2) Study drug supplies to patients and sites:
a) Shipments of study drug from the sponsor to the investigational site could be delayed 
because of transportation issues. Without study drug, the patient would not be able to stay 
on the study drug as planned per protocol.
Mitigation plan: The sites’ study drug inventory should be closely monitored. Site staff 
should notify the sponsor or delegate if they foresee shortage in study drug inventory or if 
there is any interruption in local shipping service. The sponsor will continue to monitor 
inventory at the study drug depot and study sites. Manual shipments will be triggered as 
necessary.


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3) Patient safety monitoring and follow-up:
a) Patients may be unable or unwilling to come to the study site for their scheduled study 
visits as required per protocol.
Mitigation plan: For patients who may be unable or unwilling to visit the study site for 
their scheduled study visits as required per protocol, the principal investigator or 
qualified delegate will conduct a virtual study visit, via phone or video conferencing, to 
assess the patient within the target visit window date whenever possible. During the 
virtual study visit, the following information at minimum will be reviewed:
i)
Confirm if patient has experienced any adverse events (AEs)/serious adverse events 
(SAEs)/special situations (including pregnancy) and follow-up on any unresolved 
AE/SAEs
ii) Review current list of concomitant medications and document any new concomitant 
medications
iii) If applicable, confirm that patient-reported outcomes have been completed and 
transmitted where possible
b) Patients may be unable or unwilling to travel to the site for planned assessments (eg, 
safety blood draws); hence, samples may not be analyzed at the site laboratory and/or 
sent for central laboratory analyses.
Mitigation plan: Accredited local laboratories that are not affiliated with the site may be 
utilized as appropriate to monitor patient safety until the patient can return to the site for 
their regular follow-up per protocol. Any laboratory assessments conducted at a local 
laboratory due to the pandemic will be documented accordingly. Pregnancy testing may 
be performed using a home urine pregnancy test if local laboratory pregnancy testing is 
not feasible. Alternative sample handling and storage may be possible for samples 
routinely sent to the central laboratory, sites should refer to the study laboratory manual 
and discuss with the sponsor for further guidance.
c) Patients may be unable or unwilling to attend the study visit to sign an updated informed 
consent form version if there is an update.
Mitigation plan: The site staff will follow their approved consent process and remain in 
compliance with local independent ethics committee (IEC)/institutional review board 
(IRB) and national laws and regulations. Remote consent will be allowed if it has been 
approved by the local IEC/IRB. The consent process will be documented and confirmed 
by normal consent procedure at the earliest opportunity.
d) The safety of study patients is important and testing of coronavirus disease 2019 
(COVID-19) infection will be based on local clinical guidelines for testing based on 
signs/symptoms and or suspected exposure to COVID-19.


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Mitigation plan: If patient has a diagnosis of COVID-19 while on this clinical study, 
study drugs may be held until clinical improvement or resolution in accordance with the 
treating physician’s judgment and general magrolimab dose delay guidance in the 
protocol. Additional supportive care and treatment measures for COVID-19 infection on 
the study will be performed in accordance with local institutional guidelines. Patients 
with a COVID-19 infection while participating in the clinical study will have this event 
documented as an AE in the clinical database.
4) Protocol and monitoring compliance:
a) Protocol deviations may occur, in case scheduled visits cannot occur as planned per 
protocol.
Mitigation plan: If it is not possible to complete a required procedure, an unscheduled 
visit should be conducted as soon as possible when conditions allow. The situation should 
be recorded and explained as a protocol deviation. Any missed patient visits or deviation 
to the protocol due to the pandemic must be reported in the electronic case report form 
and described in the CSR. Any virtual study visits that are conducted in lieu of clinic 
visits due to the pandemic will be documented as a protocol deviation related to the 
pandemic.
b) Monitors may be unable to carry out source data review, source data verification, or study 
drug accountability or assess protocol and Good Clinical Practice compliance. This may 
lead to delays in source data verification, an increase in protocol deviations, or under 
reporting of AEs.
Mitigation plan: The study monitor is to remain in close communication with the site to 
ensure data entry and query resolution. The study monitor is to reference the Study 
Monitoring Plan for guidance on how to conduct a remote monitoring visit. The study 
staff is to save and document all relevant communication in the study files. The status of 
sites that cannot accept monitoring visits and/or patients on site must be tracked centrally 
and updated on a regular basis.
5) Missing data and data integrity:
a) There may be an increased amount of missing data due to patients missing 
visits/assessments. This could have an impact on the analysis and the interpretation of 
clinical study data.
Mitigation plan: Implications of a pandemic on methodological aspects for the study will 
be thoroughly assessed and documented, and relevant actions will be taken as appropriate 
(ie, modification of the statistical analysis plan) and in compliance with regulatory 
authorities’ guidance. Overall, the clinical study report will describe the impact of the 
pandemic on the interpretability of study data.


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Risks will be assessed continuously, and temporary measures will be implemented to mitigate 
these risks as part of a mitigation plan, as described above. These measures will be 
communicated to the relevant stakeholders as appropriate and are intended to provide alternative 
methods that will ensure the evaluation and assessment of the safety of patients who are enrolled 
in this study.
Since these potential risks are considered mitigated with the implementation of these measures, 
the expected benefit-risk assessment of magrolimab in study patients remains unchanged. In case 
of an increase in these potential risks, which cannot be mitigated due to the escalation of a 
pandemic, enrollment of new patients will be placed on hold until the pandemic outbreak is 
under control by following local regulatory guidelines.


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Appendix 4.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1)
Definitions
a.
Definition of Childbearing Potential
For the purposes of this study, a female-born patient is considered of childbearing potential 
following the initiation of puberty (Tanner stage 2) until becoming postmenopausal unless the 
patient is permanently sterile or has medically documented ovarian failure.
Women are considered to be in a postmenopausal state when they are at least 54 years of age 
with cessation of previously occurring menses for at least 12 months without an alternative 
cause. In addition, women younger than 54 years with amenorrhea of at least 12 months also 
may be considered postmenopausal if their follicle-stimulating hormone level is in the 
postmenopausal range and they are not using hormonal contraception or hormonal replacement 
therapy. 
Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy in a female patient of any age.
b.
Definition of Male Fertility
For the purposes of this study, a male-born patient is considered fertile after the initiation of 
puberty unless the patient is permanently sterile by bilateral orchidectomy or medical 
documentation.
2)
Contraception Requirements for Female Patients
a.
Study Drug Effects on Pregnancy and Hormonal Contraception
Magrolimab is contraindicated in pregnancy as a higher incidence of total pregnancy loss has 
been observed in an embryo-fetal development toxicity study in cynomolgus monkeys and there 
is a strong suspicion of human fetotoxicity in early pregnancy based on the nonclinical data. For 
magrolimab, there is no anticipated pharmacokinetic interaction with progestin or other steroids 
based on the distinct clearance pathways.
Bevacizumab is contraindicated in pregnancy as it is anticipated to inhibit angiogenesis in the 
fetus, and thus is suspected to cause serious birth defects when administered during pregnancy. 
Advise women of the potential risk to a fetus. No contraindication to hormonal contraception is 
described in the bevacizumab prescribing information.
FOLFIRI is a therapeutic regimen consisting of 5-fluorouracil (5-FU), irinotecan, and 
leucovorin. Based on the mechanism of action, 5-FU can cause fetal harm when administered to 
a pregnant woman. In animal studies, administration of 5-FU at doses lower than a human dose 
caused teratogenicity. Based on the mechanism of action, irinotecan can cause fetal harm when 
administered to a pregnant woman. In animal studies, irinotecan has been shown to be 


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embryotoxic and teratogenic. The patient should be apprised of the potential hazard to a fetus. 
No contraindication to hormonal contraception is described in the prescribing information of any 
of the components of FOLFIRI.
b.
Contraception Requirements for Female Patients of Childbearing Potential
The inclusion of female patients of childbearing potential requires the use of highly effective 
contraceptive measures with a failure rate of less than 1% per year. They must have a negative 
serum pregnancy test at screening and a negative pregnancy test is required prior to study 
treatment administration on Cycle 1 Day 1. The Cycle 1 Day 1 pregnancy test does not need to 
be repeated if the screening pregnancy test was performed within 3 days before study treatment 
administration. Pregnancy tests will also be performed at the beginning of each cycle thereafter 
(as described in the protocol), and continue monthly up to 6 months after the end of treatment per 
the duration of required contraception.
Duration of required contraception for female patients in this clinical study should start from the 
screening visit until 6 months after last dose of the latest administered study drug.
Female patients must agree to one of the following contraceptive methods:
•
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the patient’s preferred and usual 
lifestyle. 
Or
•
Consistent and correct use of 1 of the following methods of birth control listed below: 
Nonhormonal intrauterine device (IUD) 
Hormonal IUD (must be used in conjunction with a barrier method)
Bilateral tubal occlusion (upon medical assessment of surgical success)
Vasectomy in the male partner (upon medical assessment of surgical success)
Or 
Female patients who wish to use a hormonally based method must use it in conjunction with a 
barrier method, preferably a male condom. Hormonal methods are restricted to those associated 
with the inhibition of ovulation. Hormonally based contraceptives and barrier methods permitted 
for use in this protocol are as follows:
•
Hormonal methods (each method must be used with a barrier method, preferably male 
condom)
Oral contraceptives (either combined or progesterone only)
Injectable progesterone


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Transdermal contraceptive patch
Contraceptive vaginal ring
Subdermal contraceptive implant
•
Barrier methods (each method must be used with a hormonal method)
Male condom (with or without spermicide)
Female condom (with or without spermicide)
Diaphragm with spermicide
Cervical cap with spermicide
Sponge with spermicide
Inclusion of methods of contraception in this list of permitted methods does not imply that the 
method is approved in any country or region. Methods should only be used if locally approved. 
Female patients must also refrain from egg donation, cryopreservation of cells, and in vitro 
fertilization during treatment and until the end of contraception requirement. If needed, female 
patients should be advised to seek advice about egg donation and cryopreservation prior to 
treatment.
3)
Contraception Requirements for Male Patients
It is theoretically possible that a relevant systemic concentration of study drug may be achieved 
in a female partner from exposure to the patient’s seminal fluid and pose a potential risk to an 
embryo/fetus. Male patients with female partners of childbearing potential must use condoms 
during treatment until 6 months after last dose of the latest administered study drug. If the female 
partner of childbearing potential is not pregnant, use of any locally approved contraceptive 
measure should also be considered.
Male patients must also refrain from sperm donation and cryopreservation of cells during 
treatment and until the end of contraception requirement. If needed, male patients should be 
advised to seek advice about sperm donation and cryopreservation prior to treatment.
4)
Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method. A female condom and a male condom should not be used 
together.


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5)
Procedures to be Followed in the Event of Pregnancy
Female patients will be instructed to notify the investigator if they become pregnant or suspect 
they are pregnant at any time from start of the study to 6 months after the last study drug dose. 
Study drug must be discontinued immediately.
Male patients whose partner has become pregnant or suspects she is pregnant from start of study 
to 6 months after the last the study drug dose must also report the information to the investigator. 
Partner pregnancy information will not be collected in this study; however, the investigator 
should reinforce proper contraception use with the study patient if a partner pregnancy is 
reported. Instructions for reporting pregnancy and pregnancy outcome are outlined in 
Section 7.4.2.3.


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Appendix 5.
Toxicity Grading Scale for Severity of Adverse Events and 
Laboratory Abnormalities
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_R
eference_8.5x11.pdf


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Appendix 6.
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade
Description
0
Fully active, able to carry on all predisease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light 
or sedentary nature (eg, light house work, office work)
2
Ambulatory and capable of all self-care but unable to carry out any work activities.
Up and about more than 50% of waking hours
3
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5
Dead
{Oken 1982}


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Appendix 7.
Response Evaluation Criteria in Solid Tumors (RECIST V1.1)
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response 
evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 
2009;45:228-247.


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Appendix 8.
European Organisation for Research and Treatment of Cancer 
Quality of Life Questionnaire – Core Questionnaire 
(EORTC QLQ-C30)
ENG.LISH 
EORTC QLQ-C 3 0 (nl' ion 3) 
We are interested in some lbings about you and your he.alth. !'lease answer all of the questions yourself by circling the 
number tbai best applies to you. There are 1,0 "right" or ",vron,g ' arnswers. Tile info=
.tim, that you prm'!ic!e will 
renmn s!ricily conf'ic!enlial. 
P ease 
in your initials: 
Your birlhdate (Da,y, Monlh, Year): 
Todacy's dat!e {Day, Month, Y eat} 
31 
Do you have any lroub e doing: slrenuous aefa'!iti.e:s, 
lil.-e carrying a hea,-y ~ opping bag or a suitcase? 
2. 
Do you have any lroub e hling a lon.e: wal.k? 
3. 
Do you have any troub e hling a sh.ott walk outside of ilie house. 
4. 
Do you need to stay in bed or a ,charr during the day? 
5. 
Do you need help with ea.ling, dres.smg, wasbigg 
yourself or using dice toilet? 
Du1in.g the pa.st week: 
6. 
8. 
9. 
0. 
1. 
n 
B. H ;n.,-e you lacked appetite? 
]4. H ;n.,-e you felt ll>auseated? 
]5. H ;n.,-e you •.-omited. 
6. H;n.,-e you beeill eoi,stipated? 
Please ~o on to the ll:ext page 
. fac-h 
4 
4 
3 
4 
3 
4 
2 
3 
4 
i'iotat 
A 
Quile 
Yery 
All 
Little 
a Bit 
l\fac-h 
2 
3 
4 
2 
3 
4 
2 
3 
4 
3 
4 
3 
4 
2 
3 
4 
3 
4 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 


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Du!l.ing the pa,st eek: 
7. H;;iveyou had dianhea: . 
8. \Ve-re you tired . 
9.. Did pam mteri'ere "'ri.th your ,daily c:cti.i.ties. 
21_ Ha-.re ·you had. difficulty in concentro1!in,g ,cm things, 
.like i,ea,ding a newspaper ,or Ti'iroltcbin,g tele.,--is.-ion? 
2 L D.id you feel tense? 
23-. Did )"O.U feel iiribb..e? 
24. Did yo.a feel depressed?' 
25. Ha""--e you ha.d difficulty reme:mberin,g things.? 
26. H;;,s your pl\.ysica:l condmon ar medic.al b:ea:ttnen 
interfered with your family life . 
2 .. H;;,s. your :pl\.ysica:l condmon ar medic.al!JJ1htl~l!l.t 
:interfered with your social c:cfu..i.ties 
28. H;;,s. your :pl\.ysica:l condmon ar medicill lrea:mient 
,caused ·you financial diffi.cw 
-· 
Fm· tlhe foDowm 
best applies to 
29 .. 
4 
5 
6 
30. 
rate }'Olll. ,o,·e:rall quality of life during the past week . 
3 
4 
5 
6 
V ery poor 
O Cop:,-"li;_:;11199':l ilO:il.TC Qnzlity<1fli:6, Group ... '\ll .. cghtu;,;;on-..1. 'Vimi<oi 3.0 
I'iot :d 
A 
Quite 
Yery 
Al!I 
Uttle 
:1 Bit 
Mu~h 
2 
3 
4 
3 
4 
3 
4 
4 
4 
4 
4 
3 
4 
3 
4 
3 
4 
3 
4 
3 
4 
7 
Ex.cellecl" 
7 
Ex.celleci" 


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Appendix 9.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
Health Questionnaire 
English version for the UK 
UK (Er(Jlish) © 2009 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group 


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Under each heading, please tick the ONE box that best describes your health TODAY. 
MOBILITY 
I have no problems in walking about 
I have slight problems in walking about 
I have moderate problems in walking about 
I have severe problems in walking about 
I am unable to walk about 
SELF-CARE 
I have no problems washing or dressing myself 
I have slight problems washing or dressing myself 
I have moderate problems washing or dressing myself 
I have severe problems washing or dressing myself 
I am unable to wash or dress myself 
USUAL ACTIVITIES (e.g. work, study, housework, family or 
leisure activities) 
I have no problems doing my usual activities 
I have slight problems doing my usual activities 
I have moderate problems doing my usual activities 
I have severe problems doing my usual activities 
I am unable to do my usual activities 
PAIN / DISCOMFORT 
I have no pain or discomfort 
I have slight pain or discomfort 
I have moderate pain or discomfort 
I have severe pain or discomfort 
I have extreme pain or discomfort 
ANXIETY/ DEPRESSION 
I am not anxious or depressed 
I am slightly anxious or depressed 
I am moderately anxious or depressed 
I am severely anxious or depressed 
I am extremely anxious or depressed 
2 
UK (English) © 2009 EuroQof Group EQ-5O™ is a trade mark of the EuroQof Group 


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• 
We would like to know how good or bad your health is TODAY. 
• 
This scale is numbered from Oto 100. 
• 
100 means the best health you can imagine. 
0 means the worst health you can imagine. 
• 
Mark an X on the scale to indicate how your health is TODAY. 
• 
Now, please write the number you marked on the scale in the box 
below. 
YOURHEALTHTODAY= D 
3 
UK (English) © 2009 EuroQol Group EQ-5O™ is a trade mark of the EuroQol Group 
The best health 
you can imagine 
100 
The worst health 
you can imagine 
95 
90 
85 
80 
75 
70 
65 
60 
55 
50 
45 
40 
35 
30 
25 
20 
15 
10 
5 
0 


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Gilead Sciences, Inc. 
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Appendix 10.
FACT Colorectal Symptom Index (FCSI)
Below is a list of statements that other people with your illness have said are important. Please 
circle or mark one number per line to indicate your response as it applies to the past 
7 days.
Not at 
all
A little 
bit
Some-
what
Quite
a bit
Very 
much
GP1
I have a lack of energy
0
1
2
3
4
GP4
I have pain
0
1
2
3
4
C2
I am losing weight
0
1
2
3
4
C5
I have diarrhea (diarrhoea)
0
1
2
3
4
GP2
I have nausea
0
1
2
3
4
C1
I have swelling or cramps in my stomach area
0
1
2
3
4
C6
I have a good appetite
0
1
2
3
4
GF3
I am able to enjoy life
0
1
2
3
4
GF7
I am content with the quality of my life right 
now
0
1
2
3
4


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Appendix 11.
Authorization Status of Study Interventions
Study Intervention Name
Category
Authorized in at Least 
1 Country Following EU 
Regulation No. 536/2014
To Be Used per Label 
(Marketed Products Only)
Magrolimab
Study Drug
No
NA
Bevacizumab
Study Drug 
Yesa
Yes
Leucovorin Calcium
Study Drug 
Yesa
Yes
Levoleucovorin Calcium
Study Drug
Yesa
Yes
Fluorouracil
Study Drug 
Yesa
Yes
Irinotecan Hydrochloride
Study Drug 
Yesa
Yes
Acetaminophen
AxMP
Yesa
Yes
Diphenhydramine
AxMP
Yesa
Yes
Dexamethasone
AxMP
Yesa
Yes
AxMP = auxiliary medicinal product; EU = European Union; NA = not applicable
a
Rationale described in Sections 1.3 and 1.3.3.


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Appendix 12.
Country-Specific Requirements
Not applicable.


Magrolimab 
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Amendment 5 
Appendix 13. 
Amendment History 
High-level summaries of the histo1y of this study's amendments are provided in tabular f01m in 
the subsection below (from most recent amendment to oldest), with changes listed in order of 
impo1tance. Minor changes such as the con ection of typographic enors, grammar, or fo1m atting 
are not detailed. 
Separate summaiy of change documents for earlier amendments ai·e available upon request 
A sepai·ate tracked change (red-lined) document compai·ing Amendment 4 to this amendment 
will be made available upon the publication of this protocol. 
Amendment 5 (31 October 2023) 
Rationale fo1· Key Changes Included in Amendment 5 
Clarified that all the safety laborato1y assessments should be conducted at the 
central laborat01y unless local laborat01y testing is specified. 
Updated to inco1porate co1ticosteroids as auxilia1y medicinal products for this 
clinical study. 
Amended to include overlapping toxicities reported in Version 12 of the IB. 
Clarified the efficacy assessments regarding confinnation of disease progression. 
Changed the grade for peripheral neuropathy from more than 1 to more than 2 in 
exclusion criterion No. 9. 
Affected Sections 
Tables 2 and 9 
Section 1.3.3 and 
Appendix 11 
Section 1.6 
Table 2 and Sections 3 .4.1 
and 6.3.10 
Section 4.3 
Section 4.3 
Section 4.3 
Removed the requirement of sponsor's approval for withholding magrolimab in 
Section 5.5.2 
case of treatment-emergent and/or related adverse events. 
Updated to inco1porate guidance for the use of corticosteroids as premedication 
Section 5.5.3 
for the first few infusions of magrolimab. 
Updated to add clarifications for dose administration. 
Tables 5 and 6 
Updated to allow flexibility in bevacizumab and FOLFIRI infusion times per local 
Section 5.6 
practice. 
Specified the computed tomography (CT) and magnetic resonance imaging (MRI) 
Section 6.3. 10 
scan sites and clarified the requirement for scans at end of treatment. 
Text regarding patients with low baseline hemoglobin level moved from Section 
Section 7 .8.1 
7.8.1.3.1 to Section 7.8.1.2 to better align the infonnation with the section 
headers. 
Replaced "blood" with "extended RBC" to align with the updated investigator's 
Section 7 .8. 1.1 
brochure. 
Updated the Management of Infusion-Related Reactions info1mation 
Section 7 .8.1.4 
CONFIDENTIAL 
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Rationale for Key Changes Included in Amendment 5
Affected Sections
Added 2 new sections “Severe Neutropenia” and “Serious Infections” to the 
Toxicity Management section, to provide guidelines for dose delay and 
discontinuation in case of severe neutropenia and serious infections.
Sections 7.8.1.7 and 7.8.1.8
Incorporated changes from Administrative Amendment 4.0.1.
Sections 7.8.1.1 and 7.8.1.3, 
and Appendix Table 1
Incorporated changes from Administrative Amendment 4.0.2.
Table 2, Section 5.5.2, and 
Appendix Table 1
Specified the version of RECIST as 1.1.
Throughout, as needed
Minor changes to correct typographic errors and provide clarification.
Throughout, as needed
Amendment 4 (21 June 2023)
Rationale for Key Changes Included in Amendment 4
Affected Sections
Added a Gilead Data Review Committee to monitor safety data at prescribed 
intervals and provided stopping rules based on Grade 4 or 5 treatment-related 
adverse events. 
Sections 3.1.2.1 and 8.12
Required therapy for inclusion updated to allow prior capecitabine combined with 
oxaliplatin.
Synopsis, Sections 4.2 and 
4.3
Optional prescreening consent added for sample collection.
Table 1, Section 6.2.1
Added further laboratory testing.
Tables 2 and 10, 
Sections 6.3.9 and 7.8.1.3
Timing of doses for combination therapy updated to providing flexibility of 
dosing over 2 days.
Sections 5.5 and 5.6
Effects of magrolimab on pregnancy and hormonal contraception updated based 
on current data.
Appendix 4
Clarification of adverse event screening assessment.
Table 1
Clarification of standard of care procedure language.
Section 6.2
Clarification of screening procedure language.
Section 6.3.10
Clarification added that leucovorin dose may be adjusted based on local 
guidelines.
Section 5.5
Clarification added that patient-reported outcome assessments can be waived if 
there is a barrier to completion.
Table 2 and Section 6.3.14 
Option for local sourcing of bevacizumab and FOLFIRI added.
Sections 5.3.2 and 5.4.2
Guidance for reporting temperature excursions during magrolimab storage added.
Section 5.2.3
Introduction updated based on current clinical practice.
Section 1.3.1
Minor changes to correct typographic errors.
Throughout, as needed


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Appendix 14.
Sponsor Signature Page
GILEAD SCIENCES, INC.
333 LAKESIDE DRIVE
FOSTER CITY, CA 94404
USA
A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in 
Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously 
Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
GS-US-587-6156, Amendment 5, 31 October 2023
APPROVAL OF CLINICAL STUDY PROTOCOL
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval. 
[See appended electronic signature]
Primary Medical Monitor
Signature
[See appended electronic signature]
Date
PPD


Prot GS-US-587-6156 amd-5
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
01-Nov-2023
06:50:28
PPD

SAP_001.pdf: 
(r) GILEAU 
STATISTICAL ANALYSIS PLAN 
Study Title: 
A Phase 2, Randomized, Open-Label Study Evaluating the 
Safety and Efficacy ofMagrolimab in Combination With 
Bevacizumab and FOLFIRI Versus Bevacizumab and 
FOLFIRI in Previously Treated Advanced Inoperable 
Metastatic Colorectal Cancer (mCRC) 
Name of Test Drug: 
Magrolimab in Combination With Bevacizumab and 
FOLFIRI 
Study Number: 
GS-US-587-6156 
Protocol Version (Date): 
Amendment 5 (31 October 2023) 
Analysis Plan Version: 
1.0 
Analysis Plan Date: 
16 July 2024 
Analysis Plan Author(s): 
PPD 
------
CONFIDENTIAL AND PROPRIETARY INFORMATION 


Magrolimab
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Statistical Analysis Plan
Version 1.0
CONFIDENTIAL
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16 July 2024
TABLE OF CONTENTS
STATISTICAL ANALYSIS PLAN ...............................................................................................................................1
TABLE OF CONTENTS................................................................................................................................................2
LIST OF IN-TEXT TABLES .........................................................................................................................................4
LIST OF IN-TEXT FIGURES........................................................................................................................................4
LIST OF ABBREVIATIONS.........................................................................................................................................5
1.
INTRODUCTION..................................................................................................................................................7
1.1.
Study Objectives and Endpoints................................................................................................................7
1.2.
Study Design .............................................................................................................................................8
1.2.1.
Study Design Overview...........................................................................................................8
1.2.2.
Safety Run-in Cohort...............................................................................................................9
1.2.3.
Randomized Cohort.................................................................................................................9
1.2.4.
Dosage and Administration of Study Treatment...................................................................10
1.3.
Sample Size and Power ...........................................................................................................................11
2.
TYPE OF ANALYSIS .........................................................................................................................................12
2.1.
Dose Determination Analysis..................................................................................................................12
2.2.
Treatment-related Toxicity Monitoring Analysis....................................................................................12
2.3.
Final Analysis..........................................................................................................................................12
3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES.............................................................................13
3.1.
Analysis Sets ...........................................................................................................................................13
3.1.1.
All Enrolled Analysis Set ......................................................................................................13
3.1.2.
Intent-to-Treat (ITT) Analysis Set.........................................................................................13
3.1.3.
Modified ITT (mITT) Analysis Set.......................................................................................13
3.1.4.
Safety Analysis Set................................................................................................................13
3.1.5.
Dose-Limiting Toxicity (DLT) Analysis Set ........................................................................13
3.1.6.
Pharmacokinetic Analysis Set ...............................................................................................14
3.1.7.
Immunogenicity Analysis Set................................................................................................14
3.2.
Subject Grouping.....................................................................................................................................14
3.3.
Strata and Covariates...............................................................................................................................14
3.4.
Examination of Subject Subgroups .........................................................................................................15
3.5.
Adjustment for Multiplicity.....................................................................................................................15
3.6.
Missing Data and Outliers.......................................................................................................................15
3.6.1.
Missing Data..........................................................................................................................15
3.6.2.
Outliers ..................................................................................................................................15
3.7.
Data Handling Conventions and Transformations ..................................................................................15
3.8.
Analysis Visit Windows..........................................................................................................................17
3.8.1.
Definition of Study Day ........................................................................................................17
3.8.2.
Analysis Visit Windows........................................................................................................17
3.8.3.
Selection of Data in the Event of Multiple Records in the Same Visit .................................18
3.9.
Assessment of COVID-19 Impact...........................................................................................................18
4.
PROTOCOL DEVIATIONS................................................................................................................................19
5.
SUBJECT INFORMATION ................................................................................................................................20
5.1.
Patient Enrollment and Disposition.........................................................................................................20
5.2.
Extent of Study Treatment Exposure ......................................................................................................21
5.2.1.
Duration of Exposure to Study Drug.....................................................................................21
5.2.2.
Relative Dose Intensity..........................................................................................................21
CCI-


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5.3. 
Demographics and Baseline characteristics ............................................................................................ 21 
5.4. 
Prior Anti-cancer Therapy ....................................................................................................................... 22 
5.5. 
Prior and On Study Radiation Therapy ................................................................................................... 22 
5.6. 
Prior and On Study Sw-geries and Procedw-es ........................................................................................ 22 
5.7. 
Medical Histo1y ....................................................................................................................................... 22 
5.8. 
Prior and Concoinitant Medications ........................................................................................................ 22 
5.9. 
On Study Treatment and Post Study Treatment Anti-cancer Therapies ................................................. 22 
6. 
EFFICACY ANALYSES ..................................................................................................................................... 23 
6.1. 
Pri1nruy Efficacy Endpoints .................................................................................................................... 23 
6.1.1. 
Definition of the Prima1y Efficacy Endpoints ....................................................................... 23 
6.1.2. 
Analysis of the Prima1y Efficacy Endpoint ........................................................................... 23 
6.1.3. 
Sensitivity Analysis of the Primruy Efficacy Endpoint.. ....................................................... 24 
6.2. 
Secondruy Efficacy Endpoints ................................................................................................................ 24 
6.2.1. 
Definition of Seconda1y Efficacy Endpoints ......................................................................... 24 
6.2.2. 
Anal sis Methods for Secondru Efficac End oints ........................................................... 26 
6.4. 
Changes From Protocol-Specified Efficacy Analyses ............................................................................ 28 
7. 
SAFETY ANALYSES ......................................................................................................................................... 29 
7.1. 
Adverse Events and Deaths ..................................................................................................................... 29 
7.1.1. 
Adverse Event Dictiona1y ..................................................................................................... 29 
7.1.2. 
Adverse Event Severity ......................................................................................................... 29 
7.1.3. 
Relationship of Adverse Events to Study Treatment ............................................................ 29 
7.1.4. 
Serious Adverse Events ......................................................................................................... 29 
7.1.5. 
Treatinent-Emergent Adverse Events .................................................................................... 29 
7.1.6. 
SW'lllllaries of Adverse Events and Deaths ............................................................................ 30 
7.1.7. 
Additional Analysis of Adverse Events ................................................................................ 32 
7.2. 
Laborato1y Evaluations ........................................................................................................................... 33 
7.2.1. 
SW'lllllaries ofNl.lllleric Laborat01y Results .......................................................................... 33 
7.2.2. 
Graded Laborato1y Values .................................................................................................... 33 
7.2.3. 
Liver-related Laborat01y Evaluations .................................................................................... 34 
7.3. 
Pregnancy Test ........................................................................................................................................ 35 
7.4. 
Changes From Protocol-Specified Safety Analyses ................................................................................ 35 
8. 
CHANGES FROM PROTOCOL-SPECIFIED ANALYSES .............................................................................. 36 
9. 
PHARMACOKINETIC (PK) AND IMMUNOGENICITY ANALYSES .......................................................... 37 
9.1. 
PK Analyses ............................................................................................................................................ 37 
9.2. 
Irmnunogenicity analysis ......................................................................................................................... 37 
10. BIOMARKERANALYSIS ................................................................................................................................. 39 
11. REFERENCES .................................................................................................................................................... .40 
12. SOFTWARE ........................................................................................................................................................ .41 
13. APPENDICES ..................................................................................................................................................... .42 
Appendix 1. 
Appendix 2. 
Appendix 3. 
Appendix 4. 
CONFIDENTIAL 
RECIST 1.1-based Assessments - Overall visit response ...................................................... .42 
Overview ofEORTC QLQ-C30 and Questionnaire ............................................................... .43 
5-Level Ew-oQol 5 Dimensions Questionnaire (EQ-5D-5L) .................................................. .46 
FACT Colorectal Symptom Index (FCSI) .............................................................................. .49 
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LIST OF IN-TEXT TABLES
Table 1-1.
Safety Run-in Cohort Dosing and Dose De-escalation Regimen............................................10
Table 1-2.
Randomized Cohort Dosing Regimen.....................................................................................11
Table 2-1.
Stopping Boundary Due to Toxicity (Phase 2 Randomized Cohort Arm A) ..........................12
Table 3-1.
Analysis Visit Windows for Lab By-visit Summaries ............................................................17
Table 6-1.
Censoring rule for primary and sensitivity analysis of PFS ....................................................23
LIST OF IN-TEXT FIGURES
Figure 1-1.
Study Schema ............................................................................................................................9


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LIST OF ABBREVIATIONS
ADA
anti-drug antibody
AE
adverse event
AECI
adverse events of clinical importance
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AST
aspartate transaminase
ATC
Anatomical Therapeutic Chemical
BMI
body mass index
BOR
best overall response
BSA
body surface area
CBR
clinical benefit rate
CI
confidence interval
CR
complete response
CRF
case report form
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
DOR
duration of response
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
EOT
end of treatment
KM
Kaplan-Meier
MedDRA
Medical Dictionary for Regulatory Activities
mITT
Modified intent to treat
NA
not applicable
NCI
National Cancer Institute
NE
not evaluable
NTLs
non-target lesions
ORR
objective response rate
OS
overall survival
PD
disease progression
PFS
progression-free survival
PK
pharmacokinetics
PR
partial response
PT
preferred term
Q1, Q3
first quartile, third quartile
RECIST
Response Evaluation Criteria in Solid Tumors (version 1.1)
SAE
serious adverse event
SAP
statistical analysis plan


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SD
stable disease
SE
standard error
SMQ
Standard MedDRA Query
StD
standard deviation
SOC
system organ class
TLs
target lesions
ULN
upper limit of normal
WHO
World Health Organization


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1.
INTRODUCTION
This statistical analysis plan (SAP) describes the statistical analysis methods and defines key 
elements including variable definitions for the final analysis of data of Study GS-US-587-6156 
in support of the clinical study report (CSR). This SAP is based on the study protocol 
Amendment 5 dated 31 October 2023. Any changes made after the finalization of the SAP will 
be documented in the CSR.
Analysis methods specified in this document take precedence over those described in protocol 
should there be any difference.
1.1.
Study Objectives and Endpoints
Primary Objectives
Primary Endpoints
Safety Run-in Cohort:
•
To evaluate the safety, tolerability, and 
recommended Phase 2 dose (RP2D) of 
magrolimab in combination with 
bevacizumab and FOLFIRI in previously 
treated patients with advanced inoperable 
mCRC
Randomized Cohort:
•
To evaluate the efficacy of magrolimab in 
combination with bevacizumab and FOLFIRI 
in mCRC as determined by PFS by 
investigator assessment
Safety Run-in Cohort:
•
Incidence of dose-limiting toxicities (DLTs), adverse 
events (AEs), and laboratory abnormalities according 
to National Cancer Institute (NCI) Common 
Terminology Criteria for Adverse Events (CTCAE), 
Version 5.0 
Randomized Cohort:
•
PFS, defined as the time from the date of 
randomization until the earliest date of documented 
disease progression as determined by investigator 
assessment using Response Evaluation Criteria in Solid 
Tumors Version 1.1 (RECIST V1.1), or death from 
any cause, whichever occurs first
Secondary Objectives
Secondary Endpoints
Randomized Cohort:
•
To evaluate objective response rate (ORR) by 
investigator assessment 
•
To evaluate additional measures of efficacy of 
magrolimab in combination with 
bevacizumab and FOLFIRI, including 
duration of response (DOR) and OS
•
To evaluate patient-reported outcomes 
(PRO)/quality-of-life measures for the 
Randomized Cohort in mCRC with 
magrolimab in combination with 
bevacizumab and FOLFIRI
Safety Run-in and Randomized Cohort: 
•
To evaluate the PK and immunogenicity of 
magrolimab in combination with 
bevacizumab and FOLFIRI
Randomized Cohort:
•
Confirmed ORR, defined as the proportion of patients 
with complete response (CR) or partial response (PR) 
on 2 assessments, at least 28 days apart, as determined 
by investigator assessment using RECIST V1.1 
•
DOR, defined as time from first documentation of CR 
or PR to the earliest date of documented disease 
progression as determined by investigator assessment, 
per RECIST V1.1, or death from any cause, whichever 
occurs first 
•
OS, defined as time from date of randomization to 
death from any cause
•
PRO assessments (European Organisation for Research 
and Treatment of Cancer Quality of Life Questionnaire 
– Core Questionnaire [EORTC-QLQ-C30], the 5-level 
EuroQol 5 dimensions questionnaire [EQ-5D-5L]) 
scores, and Functional Assessment of Cancer Therapy 
[FACT] Colorectal Symptom Index [FCSI] 


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Safety Run-in and Randomized Cohorts: 
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• 
Magrolimab concentration versus time and anti.chug 
antibodies (ADA) to magrolimab 
1.2. 
Study Design 
1.2.1. 
Study Design Overview 
This is a Phase 2, randomized, open-label, multicenter study to evaluate magrolimab in 
combination with bevacizumab and FOLFIRI in reviousl treated atients with advanced 
This study will consist of the following 2 coho1is: 
• 
Safety Run-in Cohort: magrolimab in combination with bevacizumab and FOLFIRI in 
previously treated patients with advanced inoperable mCRC 
After completion of the Safety Run-in Coho1i, the Randomized Cohort will be open to 
emollment. 
• 
Randomized Cohort: magrolimab in combination with bevacizumab and FOLFIRI 
(Experimental Alm A) versus bevacizumab and FOLFIRI (Control Alm B) in previously 
treated patients with advanced inoperable mCRC. 
Approximately 135 patients may be emolled in the study, with approximately 6 to 18 patients in 
Safety Run-in Coho1i (additional patients could be emolled in this coho1i or in dose de-escalation 
coho1is) and approximately 117 patients in the Randomized Coho1i Alms A and B. 
The study schema is presented in Figure 1-1. 
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Figure 1-1. 
Study Schema 
Previously-treated 
inoperable met~~tatk 
CRC patients who: 
Progressed on or after 
one prior systemic 
therapy 
Ineligible for 
checkpoint inhibitor 
therapy 
N=135 
Safety Run-in 
Magrolunab , 
£lPVclCI/Ufflc1b t f()( flRI ) 
N =6to18' 
Safety evaluat;on 
_. 
&RP20 
_. 
Randomized Phase 2 
Arm A: Magrohmab (up to 30 mg/kg) , 
Bevacizumab + FOLFIRI 
N = 78 
Arm R· Revacimmab + FOi FIRI 
N= 39 
5-FU = 5-fluorotu·acil; CRC = colorectal cancer; FOLFIRI = 5-fluorotu·acil, irinotecan, and leucovorin----
; RP2D = rec~
dose; 
a 
: 111notecan 180 mg/rn2, leucovorin 400 mg/rn2, fluorotu·acil 400 mg/m2 
b 
Additional patients may be enrolled in the safety nm-in or in dose de-escalation cohorts 
1.2.2. 
Safety Run-in Cohort 
Initially, approximately 6 patients will be emolled in the Safety Run-in Coho1i at a sta1iing dose 
level. A DLT assessment period of28 days will occur. 
Although no dose-dependent toxicities have been observed with magrolimab, in order to 
preserve the efficacious doses of the combination pa1iner dmgs, dose de-escalation will take 
place for magrolimab as follows: 
• 
I 
1.2.3. 
Randomized Cohort 
Once the Safety Run-in Coho1i is completed and the RP2D for magrolimab in combination with 
bevacizumab and FOLFIRI is determined, the sponsor will open the Randomized Cohort. 
In this open-label, randomized, 2-aim study, patients with mCRC will be randomized in a 
2:1 ratio to receive either magrolimab in combination with bevacizumab and FOLFIRI 
(Experimental Alm A) or bevacizumab and FOLFIRI (Control Alm B). 
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1.2.4. 
Dosage and Administration of Study Treatment 
The study ti·eatment dosing regimen for the safety nm-in and randomized cohorts is presented in 
Table 1-1 and Table 1-2. 
Table 1-1. 
Safety Run-in Cohort Dosing and Dose De-escalation Regimen 
Dose Schedule (Day per 28-Day Cycle) 
Drug/Dose/Route 
Cycle 1 
Cycle 2 
Cycle3+ 
Bevacizumab 
Days 1, 15 
Days 1, 15 
Days 1, 15 
5 mg/kg IV eve1y 2 weeks• 
FOLFIRIIVb 
Days 1, 15 
Days 1, 15 
Days 1, 15 
Irinotecan 180 mg/m2 over 30-90 minutes on first 
day of dose administration 
Leucovorin 400 mg/m2 over 2 hours on first day 
of dose administrationc 
Fluorouracil 400 mg/m2 bolus on first day of dose 
administration, followed by 2400 mg/m2 over 
46 hours, continuous infusion 
Magrolimab Administration 
Magrolimab 
1 mg/kg IV (3 hours ± 30 min) 
Magrolimab sta1ting dose level 
30 mg/kg IV (2 hours ± 30 min) 
Magrolimab 
30 mg/kg IV (2 hours ± 30 min) 
Magrolimab de-escalation Level - 1 
20 mg/kg IV (2 hours ± 30 min) 
Magrolimab de-escalation Level - 2 
15 mg/kg IV (2 hours ± 30 min) 
Day 1 
QW beginning at Day 8 visit and the next 6 doses 
(Cycle 1 Days 8, 15, and 22, Cycle 2 Days 1, 8, 15, and 22) 
Q2W beginning 1 week after the last weekly 30 mg/kg dose 
(sta1t ing Cycle 3 Day 1 onward) 
QW beginning at Day 8 visit and the next 6 doses 
(Cycle 1 Days 8, 15, and 22, Cycle 2 Days 1, 8, 15, and 22) 
Q2W beginning 1 week after the last weekly 20 mg/kg dose 
(starting Cycle 3 Day 1 onward) 
QW beginning at Day 8 and the next 6 doses 
(Cycle 1 Days 8, 15, and 22, Cycle 2 Days 1, 8, 15, and 22) 
Q2W beginning 1 week after the last weekly 15 mg/kg dose 
(starting Cycle 3 Day 1 onward) 
FOLFIRI = 5-fluorotu·acil, itinotecan, and leucovorin; IV = intravenous; QW = eve1y week; 2W = eve1 
a 
Bevacizumab should be administered er standard of care and/or institutional 
idelines. 
b 
c 
Levo eucovonn 200 m m may e used ifleucovorin is unavailable. Generics for leucovorin or levoleucovorin are also 
pemiitted. Leucovo1in and levoleucovo1in should be administered per standard of care and/or institutional guidelines. 
Recommendations include administering the first dose over 2 hotu·s. Different leucovorin doses may be used if 
recommended by regional or institutional guidelines. 
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Table 1-2. 
Randomized Cohort Dosing Regimen 
Dose Schedule (Day per 28-Day Cycle) 
Drug/Dose/Route 
Cycle 1 
Cycle 2 
Cycle 3+ 
Bevacizumab 
Days 1, 15 
Days 1, 15 
Days 1, 15 
5 mg/kg IV eve1y 2 weeks• 
FOLFIRIIV1> 
Days 1, 15 
Days 1, 15 
Days 1, 15 
Irinotecan 180 mg/m2 over 30-90 minutes on first 
day of dose administration 
Leucovorin 400 mg/m2 over 2 hours on first day 
of dose administra.tionc 
Fluoroura.cil 400 mg/m2 bolus on first day of dose 
administration, followed by 2400 mg/m2 over 
46 hours, continuous infusion 
Magrolimab Administration 
Magrolimab 
1 mg/kg IV (3 hours ± 30 min) 
Magrolimab 
RP2D IV (2 hours ± 30 min) 
Magrolimab 
RP2D IV (2 hours ± 30 min) 
Day 1 
QW beginning at Day 8 visit and the next 6 doses 
(Cycle 1 Days 8, 15, and 22, Cycle 2 Days 1, 8, 15, and 22) 
Q2W beginning 1 week after the last weekly RP2D 
(starting Cycle 3 Day 1 onward) 
FOLFIRI = 5-fluorouracil irinotecan, and leucovorin; IV = intravenous; QW = eve1y week; Q2W = eve1y 2 weeks; 
b 
c 
eve eucovonn 
m m may e used ifleucovorin is unavailable. Generics for leucovorin or levoleucovorin are also 
pemiitted. Leucovorin and levoleucovorin should be administered per standard of care and/or institutional guidelines. 
Recommendations include administering the first dose over 2 hotu·s. Different leucovorin doses may be used if 
recommended by regional or institutional guidelines. 
1.3. 
Sample Size and Power 
Gilead had decided to tenninate the study. By the time Gilead made the decision, 67 patients had 
been randomized to phase 2 randomized coho1i, which is less than the planned sample size of 
117 patients. 
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Statistical Analysis Plan 
2_ 
TYPE OF ANALYSIS 
2.1. 
Dose Determination Analysis 
2.2. 
Treatment-related Toxicity Monitoring Analysis 
Version 1.0 
Treatment-related toxicity will be monitored by a Gilead Data Review Committee (GDRC) at a 
preset frequency with the stopping boundaiy shown in Table 2-1 after the first 15 patients from 
Ann A ai·e treated at the dose level for the Randomized Phase 2 Coho1i with at least 1 cycle of 
follow up, and thereafter when safety data from 40 Ann A patients, from the first 3 cycles 
become available. The frequency of GDRC review will be outlined in the GDRC chaiier. This is 
a Pocock-type boundaiy {Ivanova 2005} that yields the probability of crossing the boundaiy of 
at most 80% when the rate of Grade 4 or higher treatment-related AEs is 33%, or the rate of 
treatment-related deaths is 15%. 
Table 2-1. 
Stopping Boundary Due to Toxicity (Phase 2 Randomized Cohort 
Arm A) 
N=lS 
N=40 
Grade 4/5 treatment-related TEAEs 
c:: 6 
c:: 15 
Treatment-related deaths 
:::: 3 
c::7 
TEAE = treatment-emergent adverse event 
2.3. 
Final Analysis 
The final analysis will be perfonned after all patients have completed the study or discontinued 
early, outstanding data queries have been resolved or adjudicated as unresolvable, and the data. 
have been cleaned and finalized. 
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3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES
Analysis results will be presented using descriptive statistics. For categorical variables, the 
number and percentage of patients in each category will be presented; for continuous variables, 
the number of patients (n), mean, standard deviation (StD) or standard error (SE), median, first 
quartile (Q1), third quartile (Q3), minimum, and maximum will be presented.
All statistical tests will be 2-sided and performed at the 5% significance level unless otherwise 
specified.
3.1.
Analysis Sets
For each analysis set, the number and percentage of patients eligible for inclusion will be 
summarized by treatment group and cohorts.
A listing of reasons for exclusion from analysis sets will be provided by patient.
3.1.1.
All Enrolled Analysis Set
All Enrolled Analysis Set includes all patients who received a study subject identification 
number in the study after screening. 
3.1.2.
Intent-to-Treat (ITT) Analysis Set
Intent-to-treat (ITT) Analysis Set includes all patients who were randomized in the study. This is 
the primary analysis set for efficacy analsyis for Randomized Phase 2 Cohort.
3.1.3.
Modified ITT (mITT) Analysis Set
The mITT Analysis Set includes all enrolled patients who took at least 1 dose of any study drug. 
3.1.4.
Safety Analysis Set
The Safety Analysis Set includes all patients who took at least 1 dose of any study drug. This is 
the primary analysis set for safety analyses, except for DLT analysis.
3.1.5.
Dose-Limiting Toxicity (DLT) Analysis Set
For the Safety Run-in Cohort, the primary analysis set for the DLT analysis is the 
DLT-Evaluable Analysis Set, defined as all patients who meet one of the following criteria in the 
DLT-evaluable period (defined as the first 28 days): 
•
Patient experienced a DLT at any time after initiation of the first infusion of magrolimab.
•
Patient did not experience a DLT and completes at least 3 infusions of magrolimab and at 
least 2 doses of bevacizumab and FOLFIRI in the Safety Run-in Cohort.


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If a patient experiences a DLT during the DLT-assessment period, the patient will discontinue 
treatment. Patients who are not evaluable for DLT assessment in the Safety Run-in Coho1i will 
be replaced. 
3.1.6. 
Pharmacokinetic Analysis Set 
The PK Analysis Set, defined as all patients who received any amount of magrolimab and have 
at least 1 measurable posttreatment sennn concentration of magrolimab.This is the prima1y 
analysis set for all PK analyses. 
3.1.7. 
Immunogenicity Analysis Set 
Immunogenicity Analysis Set will include all patients who received any amount of magrolimab 
and have at least 1 evaluable anti-dmg antibody test result. 
-
3.2. 
Subject Grouping 
For efficacy analyses based on the ITT Analysis Set, patients will be grouped according to the 
treatment to which they were randomized. For analyses based on the Safety Analysis Set, 
patients will be grouped according to the coho1i they were emolled in and the actual treatment 
received as follows: 
• 
Safety Run-in coho1i 
• 
Phase 2 Randomized Cohort Ann A 
• 
Phase 2 Randomized Coho1i Ann B 
• 
Safety Run-in coho1i + Phase 2 Randomized Coho1i Alm A 
The actual treatment received will differ from the randomized or planned treatment only when 
their actual treatment differs from randomized or planned treatment for the entire treatment 
duration. 
For the PK Analysis Set, patients will be grouped according to the actual treatment they 
received. The same applies to the Immunogenicity Analysis Set. 
3.3. 
Strata and Covariates 
Due to the early tennination of the program, efficacy endpoints will not be evaluated using 
stratification factors as covariates or stratification variables for analyses. 
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3.4.
Examination of Subject Subgroups
There are no prespecified patient subgroupings for efficacy or safety analyses.
3.5.
Adjustment for Multiplicity
This study is exploratory/proof-of-concept in nature and therefore no formal adjustments for 
multiplicity were made.
3.6.
Missing Data and Outliers
3.6.1.
Missing Data
In general, missing data will not be imputed unless methods for handling missing data are 
specified. 
3.6.2.
Outliers
Outliers will be identified during the data management and data analysis process, but no 
sensitivity analyses will be conducted. All data will be included in the data analysis.
3.7.
Data Handling Conventions and Transformations
The following conventions will be used for the imputation of date of birth when it is partially 
missing or not collected:
•
If only year of birth is collected, then “01 July” will be imputed as the day and month of birth
•
If year of birth is missing, then date of birth will not be imputed
In general, age collected at the Study Day 1 (in years) will be used for analyses and presented in 
listings. If age at Day 1 is not available for a subject, then age derived based on date of birth and 
the date of Study Day 1 will be used instead. For screen failures or patients who are not enrolled 
or randomized, the date the first informed consent was signed will be used for the age derivation. 
Age required for longitudinal and temporal calculations and analyses (eg, estimates of creatinine 
clearance, age at date of AE) will be based on age derived from date of birth and the date of the 
measurement or event, unless otherwise specified.
Non-PK data that are continuous in nature but are less than the lower limit of quantitation (LOQ) 
or above the upper LOQ will be imputed as follows:
•
A value that is 1 unit less than the LOQ will be used to calculate descriptive statistics if the 
datum is reported in the form of “< x” (where x is considered the LOQ). For example, if the 
values are reported as < 50 and < 5.0, values of 49 and 4.9, respectively, will be used to 
calculate summary statistics. An exception to this rule is any value reported as < 1 or 
< 0.1,etc. For values reported as < 1 or < 0.1, a value of 0.9 or 0.09, respectively, will be used 
to calculate summary statistics.


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•
A value that is 1 unit above the LOQ will be used to calculate descriptive statistics if the 
datum is reported in the form of “> x” (where x is considered the LOQ). Values with decimal 
points will follow the same logic as above.
•
The LOQ will be used to calculate descriptive statistics if the datum is reported in the form 
of“≤ x” or “x” (where x is considered the LOQ).
If methods based on the assumption that the data are normally distributed are not adequate, 
analyses may be performed on transformed data or nonparametric analysis methods may be used, 
as appropriate.
PK Data Handling
Natural logarithmic transformation will be used for analyzing non-BLQ concentrations and PK 
parameters. Concentration values that are below the limit of quantitation (BLQ) will be presented 
as “BLQ” in the concentration data listing. Values that are BLQ will be treated as 0 at predose 
and postdose time points for summary purposes. The number of samples will be summarized to 
reflect the actual number of samples assessed at that time point.
At predose, if all concentration values are BLQ, then the mean, and order statistics (minimum, 
Q1, median, Q3, and maximum) will be displayed as 0 and the rest of the summary statistics 
(ie, SD and CV) will be missing. If any values are non-BLQ, then the number of samples, order 
statistics, and all summary statistics will be displayed. 
At any given postdose time point, if more than one-third of the participants have a concentration 
value of BLQ, then only the number of samples and order statistics will be displayed; otherwise, 
order statistics and summary statistics will be displayed.
The following conventions will be used for the presentation of order statistics for postdose time 
points: 
•
If at least 1 participant has a concentration value of BLQ for the time point, the minimum 
value will be displayed as “BLQ.”
•
If more than 25% of the participants have a concentration data value of BLQ for a given time 
point, the minimum and Q1 values will be displayed as “BLQ.” 
•
If more than 50% of the participants have a concentration data value of BLQ for a given time 
point, the minimum, Q1, and median values will be displayed as “BLQ.” 
•
If more than 75% of the participants have a concentration data value of BLQ for a given time 
point, the minimum, Q1, median, and Q3 values will be displayed as “BLQ.” 
•
If all participants have concentration data values of BLQ for a given time point, all order 
statistics (minimum, Q1, median, Q3, and maximum) will be displayed as “BLQ.”
PK parameters that are BLQ will be excluded before log transformation or statistical model 
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3.8.
Analysis Visit Windows
3.8.1.
Definition of Study Day
Study day will be calculated from the first dosing date of any study drug, which is the date of the 
first dose of magrolimab or the combination drug, whichever occurs first and derived as follows:
•
For postdose study days: Assessment Date – First Dosing Date + 1
•
For days prior to the first dose: Assessment Date – First Dosing Date
Therefore, Study Day 1 is the date of first dosing of any study drug. If the subject is enrolled or 
randomized but not dosed, the enrollment or randomization date will be Study Day 1.
3.8.2.
Analysis Visit Windows
Subject visits might not occur on protocol-specified days. Therefore, for the purpose of analysis, 
observations will be assigned to analysis windows.
The analysis windows for lab assessments are provided in Table 3-1. Post-infusion lab 
assessments for hemoglobin and hematocrit will use nonimal visit and will be excluded when 
applying Table 3-1.
Table 3-1.
Analysis Visit Windows for Lab By-visit Summaries
Visit Window Study Day
Analysis Visit
Nominal Study Day
Lower Limit
Upper Limit
Baseline
(none)
1a
Day 2b
2
1c
2
Week 1
8
3
11
Week 2
15
12
18
Week 3
22
19
25
Week 4
29
26
32
Week 5
36
33
39
Week 6
43
40
46
Week 7
50
47
53
Week 8
57
54
63
Week 10
71
64
77
Week xxd
(xx)*7 + 1
(xx)*7 - 6
(xx)*7 + 7
a
Prior to first dose date time
b
Day 2 visit not applicable to chemistry lab assessments. Chemistry labs assessed post first dose date time through study 
day 2 will be assigned to “Week 1” visit
c
Post first dose date time
d
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PRO will use nonimal visit for by-visit summaries of PRO assessments.
3.8.3.
Selection of Data in the Event of Multiple Records in the Same Visit
If multiple valid, nonmissing measurements exist in the same visit, records will be chosen based 
on the following rules if a single value is needed:
•
For baseline, the last nonmissing value on or prior to the first dosing date of study drug (and 
prior to first dosing time) will be selected, unless specified differently. If there are multiple 
records with the same time or no time recorded on the same day, the baseline value will be 
the average of the measurements for continuous data, or the measurement with the best 
severity for categorical data.
•
For postbaseline values:
The record closest to the nominal study day for that visit will be selected.
If there are 2 records that are equidistant from the nominal day, the later record will be 
selected.
If there is more than 1 record on the selected day, the average will be taken for 
continuous data and the worst severity will be taken for categorical data, unless otherwise 
specified.
3.9.
Assessment of COVID-19 Impact
This study was ongoing during the novel coronavirus (COVID-19) pandemic which has an 
impact on the study conduct. Some patients were unable to attend onsite visits due to shelter in 
place guidelines, site closures, or other reasons. The following special situations due to 
COVID-19 will be handled in the analysis:
•
Study treatment or study discontinuation due to COVID-19
•
Protocol deviations due to COVID-19
•
Missed and Virtual Visits due to COVID-19
•
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4.
PROTOCOL DEVIATIONS 
Patients who did not meet at least one eligibility criterion for study entry, but enrolled in the 
study will be summarized by treatment group and cohorts regardless of whether they were 
exempted by the sponsor or not, based on All Enrolled Analysis Set. The summary will also 
present the number and percentage of patients who did not meet specific criteria. 
Protocol deviations occurring after patients entered the study are documented during routine 
monitoring. The number and percentage of patients with important protocol deviations by 
deviation reason (e.g., eligibility criteria, informed consent) will be summarized by treatment 
group and cohorts based on All Enrolled Analysis Set. A by-subject listing will be provided for 
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5.
SUBJECT INFORMATION
Generally, disposition tables and all listings will be based on All Enrolled Analysis Set. Safety 
Analysis Set will be used for the summary of treatment exposure, unless otherwise specified. 
5.1.
Patient Enrollment and Disposition
Key study dates, including first patient screened, first patient enrolled, last patient enrolled, last 
patient last visit for the primary endpoint, and last patient last visit for the clinical study report 
will be provided.
A summary of patient enrollment will be provided by cohort and treatment, for each country, 
investigator and overall.
A similar enrollment table will be provided by randomization stratification group for Phase 2 
Randomized Cohort only. 
A summary of patient disposition will be provided by cohort and treatment. This summary will 
present the number of patients enrolled or randomized, the number of patients enrolled or 
randomized but not dosed, and the number of patients in each of the categories listed below:
•
Intent-to Treat (ITT) Analysis Set
•
Modified ITT (mITT) Analysis Set
•
Safety Analysis Set 
•
Discontinued each study drug (magrolimab, bevacizumab and FOLFIRI) with reasons for 
treatment discontinuation for the correscponding drug
•
Discontinued the study with reasons for discontinuation of study
For the status of study drug and study completion and reasons for discontinuation, the number 
and percentage of patients in each category will be provided. The denominator for the percentage 
calculation will be the total number of patients in the All Enrolled Analyses Set corresponding to 
that column. 
In addition, the following by-subject listings will be provided:
•
Reasons for study drug discontinuation
•
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5.2.
Extent of Study Treatment Exposure 
Extent of exposure to study treatment will be summarized using descriptive statistics for total 
duration of exposure to each study drug (magrolimab, bevacizumab and FOLFIRI), total number 
of infusions for each study drug, total number of cycles received for each study drug for each 
study drug, relative dose intensity (%) of Magrolimab, and number (%) of patients with dose 
modifications (i.e. infusion interuption, dose delayed or not administered) and reasons by cohort 
and treatment.
5.2.1.
Duration of Exposure to Study Drug
Total duration of exposure to each study drug (magrolimab, bevacizumab and FOLFIRI) will be 
defined for a subject as last dosing date minus first dosing date plus 1 day, regardless of any 
temporary interruptions in study drug administration, and will be expressed in weeks using up to 
1 decimal place (eg, 4.5 weeks).
The total duration of exposure to each study drug will be summarized using descriptive statistics 
for continuous variables, as well as using the number (i.e., cumulative counts) and percentage of 
patients exposed for at least the following time periods: 1 day, 4 weeks, 8 weeks, 12 weeks, 
16 weeks, 20 weeks, and 24 weeks, etc.
5.2.2.
Relative Dose Intensity
Relative dose intensity is the percentage of the total amount of study drug administered relative 
to the total amount of study drug expected to be administered during a patient’s actual 
on-treatment period based on the study drug regimen. 
Relative dose intensity will be summarized by formulas below for magrolimab. 
𝑅𝑒𝑙𝑎𝑡𝑖𝑣𝑒 𝑑𝑜𝑠𝑒 𝑖𝑛𝑡𝑒𝑛𝑠𝑖𝑡𝑦 (%) =
𝐶𝑢𝑚𝑢𝑙𝑎𝑡𝑖𝑣𝑒 𝑑𝑜𝑠𝑎𝑔𝑒 𝑟𝑒𝑐𝑒𝑖𝑣𝑒𝑑 𝑚𝑔
𝑘𝑔
𝑇𝑜𝑡𝑎𝑙 𝑝𝑙𝑎𝑛𝑛𝑒𝑑 𝑑𝑜𝑠𝑎𝑔𝑒 𝑜𝑓 𝑠𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝑑𝑟𝑢𝑔𝑚𝑔
𝑘𝑔
× 100
Descriptive statistics for the relative dose intensity with the number and percentage of patients 
belonging to relative dose intensity categories (eg, < 75%, ≥ 75 to < 90%,≥ 90%) will be 
provided.
Listings of study drug exposure will be provided.
5.3.
Demographics and Baseline characteristics  
Patient demographics (i.e., age, sex at birth, race, ethnicity) and baseline characteristics 
including, but not limited to, body weight [in kg], height [in cm], body mass index [BMI; in 
kg/m2], Body Surface Area [BSA; in m2] will be summarized with descriptive statistics by cohort 
and treatment. The analysis will be performed for All Enrolled Analysis Set. 
( ___ 
(_/_)) 
( I ) 


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5.4.
Prior Anti-cancer Therapy
Prior anti-cancer therapy will be coded using the World Health Organization (WHO) Drug
Dictionary.
A by-patient listing  prior anti-cancer therapy will be provided.
5.5.
Prior and On Study Radiation Therapy
A by-patient listing including information collected in eCRF and the flag for prior and on study 
radiation therapy will be provided.
5.6.
Prior and On Study Surgeries and Procedures
A by-patient listing including information collected in eCRF and the flag for prior and on study 
surgery and procedure will be provided.
5.7.
Medical History
General medical history data will be collected at screening. Medical history will be coded using 
the current version of Medical Dictionary for Regulatory Activities (MedDRA). 
A by-patient listing of medical history will be provided.
5.8.
Prior and Concomitant Medications
Medications collected at screening and during the study will be coded using the current version 
of the World Health Organization (WHO) Drug dictionary.
All prior and concomitant medications (other than per-protocol study drugs) will be provided in a 
by-patient listing.
5.9.
On Study Treatment and Post Study Treatment Anti-cancer Therapies
All on study treatment and post treatment anti-cancer therapies including flag for on-study 
treatment and post study treatment therapies will be provided in a by-patient listing. 
In case when the date of initiation of new anti-cancer therapy other than the study treatment is 
incomplete and needs to be imputed, the following algorithm will be followed:
If the day is missing but the month and year are available, then the imputed day will be first day 
of the month or the day of last dose +1 if the month and year of new anti-cancer therapy and the 
month and year of last dose are the same.
If the day and month are missing but year is available, then the imputed day and month will be 
01Jan or the date of last dose +1 if the year of new anti-cancer therapy and the year of last dose 
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6.
EFFICACY ANALYSES
Generally, summary of efficacy endpoints in this section will be based on ITT Analyses Set for 
Phase 2 Randomized Cohort, unless otherwise specified. Listings will be provided for All 
Enrolled Analysis Set. Safety run-in cohort 1 subjects will only be listed for efficacy related 
endpoints.
6.1.
Primary Efficacy Endpoints
6.1.1.
Definition of the Primary Efficacy Endpoints
For Phase 2 Randomized Cohort, the primary efficacy endpoint is progression-free survival 
(PFS) by investigator assessment, defined as the time from the date of randomization until the 
earliest date of documented disease progression as determined by investigator assessment, as 
determined based on response evaluation criteria in solid tumors (RECIST), Version 1.1, or 
death from any cause. 
6.1.2.
Analysis of the Primary Efficacy Endpoint
For Phase 2 Randomized Cohort, PFS by investigator assessment will be analyzed using Kaplan-
Meier (KM) methods. The KM estimate of the survival function will be computed, and the 
results will be presented using KM curves by treatment group. The median, Q1, Q3 will be 
provided along with the corresponding 95% CI calculated by the Brookmeyer and Crowley 
method with log-log transformation. A log-rank test will be used to compare treatment difference 
in PFS by investigator with 2-sided P-value provided. 
In addition, the treatment effect will be estimated by Hazard Ratio (HR) along with 
corresponding 2-sided 95% CI using the Cox proportional hazards regression model.
The censoring rules are summarized in Table 6-1.
Table 6-1.
Censoring rule for primary and sensitivity analysis of PFS
Situation
Primary Analysis
Alive and no disease assessment at 
baseline or post-baseline assessment*
Censored at date of randomization (or first dosing date for non-
randomized cohort)
Alive and progression-free
Censored at date of last evaluable disease assessment
Documented Progressive Disease (PD)
Progressed at date of earliest sign of PD
Death before first PD 
Progressed at date of death  
Death within 2 disease assessments 
window 
Progressed at date of death  
PD or death after ≥ 2 consecutively 
missed or not evaluable (NE) disease 
assessments
Censored at date of last evaluable assessment prior to missed or NE 
assessments, or date of randomization if there is no adequate post-
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Situation
Primary Analysis
No PD or death before or on initiation 
of subsequent anticancer therapy 
Censored at date of last evaluable assessment on or prior to subsequent 
anticancer therapy
*Baseline tumor assessment should be performed at screening visit before the start of study drug, unless otherwise specified in 
the protocol. 
Given the scheduled visit assessment scheme for randomized cohort is every 8 weeks (± 7 days) 
during the study, the definition of 2 missed visits are defined as 2 x (8 weeks + 7) days.
6.1.3.
Sensitivity Analysis of the Primary Efficacy Endpoint
There is no sensitivity analysis planned. 
6.2.
Secondary Efficacy Endpoints
6.2.1.
Definition of Secondary Efficacy Endpoints
Objective Response Rate (ORR): 
ORR is defined as the proportion of patients who achieve complete response or partial response 
that is confirmed at least 4 weeks after initial documentation of response, as determined by 
investigator assessment per RECIST, Version 1.1. 
Overall Survival (OS) 
The OS is measured from the date of randomization to the date of death from any cause. Those 
who are not observed to die during the study will be censored at their last known alive date.
Duration of response (DOR) 
DOR is defined as time from first documentation of complete response or partial response to the 
earliest date of documented disease progression as determined by investigator assessment, per 
RECIST Version 1.1, or death from any cause, whichever occurs first.
PRO endpoints measured by EORTC QLQ-C30
The EORTC QLQ-C30 consists of 30 items, which address 15 HRQoL domains: 5 functional 
scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and 
social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, 
and pain) and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and 
financial difficulties) (See details in Appendix 2). The recall period is 1 week (past week). It will 
take about 11 minutes to complete. 
According to the EORTC QLQ-C30 Scoring Manual, scores for each scale (or domain) should 
be calculated if responses are given to at least 50% of the items in that particular scale; 
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For all scales, the raw score (RS) is defined as the mean of the non-missing component items 
(Ii): RS = (I1 + I2 +…+In)/n.
Functional scales: 𝑆= (1 ―
𝑅𝑆― 1
𝑟𝑎𝑛𝑔𝑒) × 100
Symptomscales and Global health status/QoL: 𝑆= (
𝑅𝑆― 1
𝑟𝑎𝑛𝑔𝑒) × 100
All of the scales and single-item measures range in score from 0 to 100. A high scale score 
represents a higher response level. Thus a high score for a functional scale represents a high / 
healthy level of functioning, a high score for the global health status / QoL represents a high 
QoL, but a high score for a symptom scale / item represents a high level of symptomatology / 
problems.
PRO endpoints measured by EQ-5D-5L
The EQ-5D-5L is an instrument for use as a measure of health outcome {EuroQol Research 
Foundation 2017}. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the 
EQ visual analogue scale (EQ-VAS).
The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight 
problems, moderate problems, severe problems, and extreme problems. The patient is asked to 
indicate his/her health state by ticking the box next to the most appropriate statement in each of 
the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for 
that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that 
describes the patient’s health state.
The EQ-VAS records the patient’s self-rated health on a vertical VAS, where the end points are 
labeled “the best health you can imagine” and “the worst health you can imagine.” The EQ-VAS 
can be used as a quantitative measure of health outcome that reflects the patient’s own judgment.
PRO endpoints measured by FACT Colorectal Symptom Index
The FCSI is a well-validated PRO instrument as a set of brief, clinically relevant, colorectal 
cancer symptoms for assessing symptomatic response. It comprises the most important 
symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, 
swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. 
Its minimum important difference (MID) range from 1.5 to 3 has been published {Colwell 
2010}.
The FCSI questionnaire is provided in Appendix 4.


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6.2.2.
Analysis Methods for Secondary Efficacy Endpoints
Objective Response Rate (ORR)
Confirmed ORR by investigator assessment along with the 95% CI will be estimated based on 
the Clopper-Pearson method for Phase 2 Randomized Cohort. The chi-square test may be used to 
compare treatment difference in ORR. Odds ratios and corresponding 95% CIs will also be 
presented.
Overall Survival (OS)
The analysis of overall survival (OS) will be performed using the Kaplan-Meier method for 
Phase 2 Randomized Cohort in the ITT analysis set. Median, Q1, and Q3 of the DOR will be 
derived based on KM estimates along with the corresponding 95% CI by the Brookmeyer and 
Crowley method with log-log transformation. Kaplan-Meier curves will also be provided.
Duration of response (DOR)
The analysis of duration of response (DOR) will be performed using the Kaplan-Meier method 
for Phase 2 Randomized Cohort in the ITT analysis set. Median, Q1, and Q3 of the DOR will be 
derived based on KM estimates along with the corresponding 95% CI by the Brookmeyer and 
Crowley method with log-log transformation. Kaplan-Meier curves will also be provided.
Change from baseline in PRO endpoints 
The descriptive statistics will be used to summarize the observed scores at each scheduled visit 
and the change from baseline scores for each domain of EORTC QLQ-C30 at each post-baseline 
visit by treatment group in the ITT Analysis Set for Phase 2 Randomized Cohort and mITT 
Analysis Set for safety run-in cohort.
The descriptive statistics will be used to summarize the observed scores at each scheduled visit 
and the change from baseline scores for each dimension of EQ-5D-5L and EQ-VAS at each post-
baseline visit by treatment group in the ITT Analysis Set for Phase 2 Randomized Cohort and 
mITT Analysis Set for safety run-in cohort.
The descriptive statistics will be used to summarize the observed scores at each scheduled visit 
and the change from baseline scores for FCSI at each post-baseline visit by treatment group in 
the ITT Analysis Set for Phase 2 Randomized Cohort and mITT Analysis Set for safety run-in 
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6.4.
Changes From Protocol-Specified Efficacy Analyses
Due to the early termination of the program, efficacy endpoints will not be evaluated using 
stratification factors as covariates or stratification variables for stratified analysis model. For 
PRO endpoints, only descriptive statistics will be used to summarize the observed scores at each 
scheduled visit and the change from baseline scores.


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7.
SAFETY ANALYSES
Safety analysis will be performed in the Safety Analysis Set. Listing will be based on the All 
Enrolled analysis set unless specified otherwise. Analysis of DLT was performed using the DLT 
evaluable analysis set for Safety Run-in evaluations.
7.1.
Adverse Events and Deaths
7.1.1.
Adverse Event Dictionary
Clinical and laboratory adverse events (AEs) will be coded using the current version of Medical 
Dictionary for Regulatory Activities (MedDRA).
7.1.2.
Adverse Event Severity
Adverse events are graded by the investigator as Grade 1, 2, 3, 4, or 5 according to CTCAE 
Version 5.0. 
7.1.3.
Relationship of Adverse Events to Study Treatment
Related AEs are those for which the investigator selected “Related” on the AE CRF to the 
question of “Related to Study Treatment” for each study drug and overall. Relatedness will 
always default to the investigator’s choice, not that of the medical monitor. Events for which the 
investigator did not record relationship to study drug will be considered related to study drug for 
summary purposes. However, by-patient data listings will show the relationship as missing.
7.1.4.
Serious Adverse Events
Serious adverse events (SAEs) will be identified and captured as SAEs if the AEs met the 
definitions of SAEs that were specified in the study protocol. SAEs captured and stored in the 
clinical database will be reconciled with the SAE database from the Gilead Drug Safety and 
Public Health Department before data finalization.
7.1.5.
Treatment-Emergent Adverse Events 
7.1.5.1.
Definition of Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as any AEs with an onset date on or 
after the date of the first dose of study treatment up to 30 days after the date of the last dose of 
study treatment, or the day before initiation of subsequent anti-cancer therapy, whichever comes 
first. 
If the AE onset date is on or before the last dose date, the AE is considered as TEAE, regardless 
of the initiation of subsequent anti-cancer therapy.


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7.1.5.2.
Missing or incomplete Dates
If there was a missing or incomplete date for the start date or stop date of an AE, the most 
conservative approach was used for analysis. 
If the onset date of the AE is incomplete and the AE stop date is not prior to the first dosing date 
of study drug, then the month and year (or year alone if month is not recorded) of onset 
determine whether an AE is treatment emergent. The event is considered treatment emergent if 
both of the following 2 criteria are met:
•
The AE onset is the same as or after the month and year (or year alone if month is not 
recorded) of the first dosing date of study drug, and
•
The AE onset date is the same as or before the month and year (or year alone if month is not 
recorded) of the date corresponding to the cutoff date of TEAE period, which is defined as 
the 30 days after the study drug last dose date or the day before the initiation of new 
anticancer therapy (whichever is earlier)
An AE with completely missing onset and stop dates, or with the onset date missing and the stop 
date later than the first dosing date of study drug, will be considered to be treatment emergent. In 
addition, an AE with the onset date missing and incomplete stop date with the same or later 
month and year (or year alone if month is not recorded) as the first dosing date of study drug will 
be considered treatment emergent.
In case when the AE onset date is incomplete and needs to be imputed, the following algorithm 
will be followed:
•
If the day is missing but the month and year are available, then the imputed day will be the 
first dosing date if they have the same month and year, or the first day of the month 
otherwise.
•
If the day and month are missing but year is available, then the imputed day and month will 
be the first dosing date if they have the same year, or 01Jan otherwise.
7.1.6.
Summaries of Adverse Events and Deaths
7.1.6.1.
Adverse Events and Deaths
A brief, high-level summary of the number of percentage of patients who experienced at least 
1 TEAE in the categories described below will be provided for each cohort and treatment.
The number and percentage of patients who experienced at least 1 TEAE will be provided and 
summarized by SOC, PT for each cohort and treatment group.


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For the AE categories described below, summaries will be provided by SOC, PT:
•
TEAEs
•
TEAEs with Grade 3 or 4
•
TE treatment-related AEs for Magrolimab and for study drug other than Magrolimab
•
TE treatment-related AEs with Grade 3 or 4 for Magrolimab and for study drug other than 
Magrolimab
•
TE SAEs
•
TE treatment-related SAEs for Magrolimab and for study drug other than Magrolimab
•
TEAEs leading to dose interruption of Magrolimab and study drug other than Magrolimab
•
TEAEs leading to dose reduction of Magrolimab and study drug other than Magrolimab
•
TEAEs leading to discontinuation of Magrolimab and study drug other than Magrolimab
•
TEAEs leading to death
Multiple events will be counted only once per subject in each summary. Adverse events will be 
summarized and listed first in alphabetic order of SOC and then by PT within each SOC in the 
descending order of overall frequency. For summaries by severity, the most severe severity will 
be used for those AEs that occurred more than once in a given subject during the study.
In addition to the above summary tables, all TEAEs, TEAEs of Grade 3 or 4, TE SAEs, TE 
treatment-related SAEs for Magrolimab and TEAEs leading to death will be summarized by PT 
in descending order of overall frequencies.
In addition, data listings will be provided for the following:
•
All AEs, indicating whether the event is treatment emergent
•
All SAEs
•
All Deaths
•
All SAEs leading to death
•
All AEs with severity of Grade 3 or 4
•
All AEs leading to discontinuation of Magrolimab
•
All AEs leading to dose delay or interruption of Magrolimab


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A summary (number and percentage of patients) of deaths will be provided by cohort and 
treatment. Summary will include the following categories:
•
All deaths
•
Deaths within 30 days of the last dosing of study treatment
•
Deaths beyond 30 days of the last dosing of study treatment
7.1.7.
Additional Analysis of Adverse Events
7.1.7.1.
Dose Limiting Toxicity (DLT)
In Safety run-in Cohort, a summary of DLT by PT among the DLT evaluable patients will be 
provided. DLT-type AEs will also be summarized in the same way, where DLT-type AEs are 
toxicities that met protocol specified criteria of DLTs and occurred beyond the protocol-specified 
DLT assessment period (onset date beyond the 28 days period).
By-patient listing of the DLT AEs and DLT-type AEs will also be provided.
7.1.7.2.
Treatment-Emergent Adverse Events (TEAE) of Clinical Importance 
Number and percentage of participants with the following AEs of Clinical Importance (AECI) 
will be summarized by PT. 
Treatment Emergent Adverse Events of Clinical Importance
TEAE of Clinical Importance
Search Strategy
Anaemia
Medical Search Term (MST) Anemia Extravascular transient 
hemolysis
Infusion related reactions
Standardized MedDRA Queries (SMQ) Hypersensitivity 
(narrow) + within one day of latest infusion of any study drug
Severe Neutropenia
PT: Grade 3+ Febrile neutropenia, Grade 3+ Neutrophils count 
decreased, Grade 3+ Neutropenia
Serious Infections
SAE within SOC: Infections and infestations
Transfusion reactions due to magrolimab 
interference with RBC typing
MST Transfusion reactions due to magrolimab interference with 
RBC typing
Thromboembolic events
SMQ Embolic and thrombotic events (broad)
Pneumonitis
SMQ Interstitial lung disease (broad)
Myocardial Infarction
SMQ Myocardial infarction (broad)


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7.2.
Laboratory Evaluations
Laboratory data collected during the study will be analyzed and summarized using both 
quantitative and qualitative methods. Summaries of laboratory data will be provided for the 
Safety Analysis Set and will include data collected during the treatment-emergent period. The 
analysis will be based on values reported in conventional units.
7.2.1.
Summaries of Numeric Laboratory Results
Descriptive statistics will be provided by cohort and treatment group for selected laboratory test 
specified in the study protocol as follows:
•
Baseline values
•
Postbaseline maximum value
•
Change and percentage change from baseline to postbaseline maximum value
•
Postbaseline minimum value 
•
Change and percentage change from baseline to postbaseline minimum value
•
Values at each postbaseline time point 
•
Change and percentage change from baseline at each postbaseline time point
Median (Q1, Q3) of change from baseline will be plotted for the lab parameters including (but 
not limited to) hemoglobin, platelet, and absolute neutrophil counts over time.
7.2.2.
Graded Laboratory Values
The CTCAE Version 5.0 will be used to assign toxicity grades (0 to 4) to laboratory results for 
analysis. Grade 0 includes all values that do not meet the criteria for an abnormality of at least 
Grade 1. For laboratory tests with criteria for both increased and decreased levels, analyses for 
each direction (i.e., increased, decreased) will be presented separately. 
7.2.2.1.
Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last 
dose of study drug plus 30 days or the day before initiation of new anticancer therapy, whichever 
is earlier. If the relevant postbaseline lab is assessed on or before the last dose date, the 
laboratory abnormality is considered as treatment-emergent laboratory abnormality, regardless of 
the initiation of subsequent anti-cancer therapy. If the relevant baseline laboratory value is 
missing, any abnormality of at least Grade 1 observed within the time frame specified above will 
be considered treatment emergent.


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7.2.2.2.
Summaries of Laboratory Abnormalities
The following summaries (number and percentage of patients) for treatment-emergent laboratory 
abnormalities will be provided by lab test for each cohort and treatment group; patients will be 
categorized according to the most severe postbaseline abnormality grade for a given lab test:
•
Laboratory abnormalities (Grade 1 to 4 separately)
•
Grade 3 or 4 laboratory abnormalities
For all summaries of laboratory abnormalities, the denominator is the number of patients in the 
the number of patients with nonmissing postbaseline values up to 30 days after the last dosing 
date or the day before initiation of new anticancer therapy, whichever is earlier. 
By-patients listings of treatment-emergent Grade 3 or 4 laboratory abnormalities will be 
provided by subject ID number and visit in chronological order. This listing will include all test 
results that were collected throughout the study for the lab test of interest, with all applicable 
severity grades displayed. 
7.2.3.
Liver-related Laboratory Evaluations
Liver-related abnormalities after the first dose of any study drug will be examined and 
summarized for each cohort and treatment group using the number and percentage of patients 
who were reported to have the following laboratory test values for postbaseline measurements:
•
Aspartate aminotransferase (AST): > 3 times of the upper limit of reference range (ULN)
•
Alanine aminotransferase (ALT): > 3 x ULN
•
AST or ALT: > 3 x ULN
•
Total bilirubin: > 2 x ULN
•
AST or ALT > 3 x ULN and total bilirubin > 2 x ULN
•
AST or ALT > 3 x ULN and total bilirubin > 2 x ULN and alkaline phosphatase (ALP) 
< 2 x ULN
The summary will include data from all postbaseline visits up to 30 days after the last dose of 
study drug or the day before initiation of new anticancer therapy, whichever is earlier. For 
individual laboratory tests, patients will be counted once based on the most severe postbaseline 
values. For the composite endpoints of AST or ALT and total bilirubin and ALP, patients will be 
counted once when the criteria are met at the same postbaseline visit date. The denominator is 
the number of patients in the Safety Analysis Set who have at least one postbaseline visit, at 
which all relevant tests are nonmissing at the same postbaseline visit.
A listing of patients who met at least 1 of the above criteria will be provided.


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7.2.4.
Shifts Relative to the Baseline Value
Shift tables will be presented by showing change in severity grade from baseline to the worst 
grade postbaseline for hematology and chemistry tests.
7.3.
Pregnancy Test
A by-patient listing of the pregnancy test results as collected in CRF will be provided.
7.4.
Changes From Protocol-Specified Safety Analyses
Body weight, vital sign and physical examination will not be summarized.


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8.
CHANGES FROM PROTOCOL-SPECIFIED ANALYSES
Due to the early termination of the program, efficacy endpoints will not be evaluated using 
stratification factors as covariates or stratification variables for stratified analysis model. Only 
descriptive statistics will be summarized for PRO endpoints. Body weight, vital sign and 
physical examination will not be summarized.


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9.
PHARMACOKINETIC (PK) AND IMMUNOGENICITY 
ANALYSES
9.1.
PK Analyses
The PK Analysis Set will be used for summaries of PK concentration of magrolimab versus time. 
Serum concentrations will be listed and summarized for magrolimab using descriptive statistics 
by sampling time point and treatment. Box plots of serum concentration versus time will be 
generated. 
9.2.
Immunogenicity analysis
Serum samples for antidrug antibody (ADA) assessments will be conducted utilizing a tiered 
approach (screen, confirmatory and titer), and ADA data will be collected at scheduled visits 
shown in the protocol. ADA result from each sample will be reported as either positive or 
negative. If the sample is positive, the ADA titer will be reported as well. In addition, the 
presence of neutralizing antibody (nAb) will be tested for all ADA positive samples using a 
ligand-binding assay. The nAb results will be reported as positive or negative. 
Patients for ADA prevalence are defined as patients who had at least one positive ADA sample 
at any time, including baseline and post-baseline, in Immunogenicity Analysis Set.
Patients for ADA incidence are defined as evaluable patients with at least one non-missing 
baseline ADA sample and at least one post-treatment ADA sample in Immunogenicity Analysis 
Set that showed treatment-induced ADA or treatment-boosted ADA. 
Patients for nAb prevalence are defined as patients who had at least one positive nAB sample at 
any time, including baseline and post-baseline, in Immunogenicity Analysis Set
Among patients for ADA incidence, patients who had Treatment-Induced ADA or Treatment-
Boosted ADA are categorized as ADA positive by incidence, where:
•
Treatment-Induced ADA is defined as patients who had negative baseline ADA sample and 
at least one positive post-treatment ADA sample. 
•
Treatment-Boosted ADA is defined as patients who had positive baseline ADA sample and 
at least one positive post-treatment ADA sample and the (max titer of the post-treatment 
ADA) / (titer of baseline ADA) ≥ 4.
The remaining patients among patient for ADA incidence are ADA negative by incidence.
Transient ADA is defined as:
•
Treatment-Induced ADA detected only at one sampling time point during the treatment or 
follow-up observation period (excluding the last sampling time point, which ought to be 
considered persistent unless shown to be undetectable at a later time) 
or


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•
Treatment-Induced ADA detected at two or more sampling time points during the treatment 
(including follow-up period if any), where the first and last ADA-positive sample 
(irrespective of any negative samples in between) are separated by a period less than 
16 weeks, and the patient’s last sampling time point is ADA-negative.
ADA Transience Rate: the proportion of patients who had transient among patients for ADA 
incidence.
Persistent ADA is defined as: 
•
Treatment-Induced ADA detected at two or more sampling time points during the treatment 
(including follow-up period if any), where the first and last ADA-positive sample 
(irrespective of any negative samples in between) are separated by a period of 16 weeks or 
longer.
or
•
Treatment-Induced ADA incidence (i.e. Treatment-induced ADA) only in the last sampling 
time point of the treatment study period or at a sampling time point with less than 16 weeks 
before an ADA-negative last sample. 
ADA Persistence Rate: the proportion of patients who had persistent ADA among patients for 
ADA incidence.
The following ADA categories will be summarized: 
•
ADA prevalence
•
ADA positive post-baseline and positive at baseline
•
ADA not detected post-baseline and positive at baseline
•
ADA incidence
•
Treatment-induced ADA
•
Treatment-boosted ADA
•
Persistent ADA
•
Transient ADA
•
nAb prevalence 
ADA titer and nAb data will be listed for samples confirmed positive for the presence of ADA to 
study drug. The effect of ADA on PK, safety and efficacy may be examined by descriptive 
summaries if data allow. 


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11.
REFERENCES
Colwell H, Mathias S, Turner M, Lu J, Wright N, Peeters M, et al. Psychometric Evaluation of 
the FACT Colorectal Cancer Symptom Index (FCSI-9): Reliability, Validity, 
Responsiveness, and Clinical Meaningfulness. The Oncologist 2010.
EuroQol Research Foundation. EQ-5D-5L: About. Available at: https://euroqol.org/eq-5d-
instruments/eq-5d-5l-about/. Accessed: 10 August 2020. Last Updated: 18 April.  
2017:
Ivanova A, Qaqish BF, Schell MJ. Continuous toxicity monitoring in phase II trials in oncology. 
Biometrics 2005;61 (2):540-5.


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12.
SOFTWARE
SAS® Software Version 9.4. SAS Institute Inc., Cary, NC, USA.
EAST Version 6.5, Cytel Inc., MA, USA.


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13.
APPENDICES
Appendix 1.
RECIST 1.1-based Assessments - Overall visit response
The RECIST tumour response data will be used to determine each patient’s visit response 
according to RECIST version 1.1. At each visit, patients will be assigned a RECIST 1.1 visit 
response of CR, PR, SD or PD, using the information from target lesions (TLs), non-target 
lesions (NTLs) and new lesions and depending on the status of their disease compared with 
baseline and previous assessments. If a patient has had a tumour assessment which cannot be 
evaluated, then the patient will be assigned a visit response of not evaluable (NE). For patients 
with no disease at baseline (i.e. no TLs and no NTLs), evaluation of overall visit responses will 
be based on absence/presence of new lesions.  If no TLs and no NTLs are recorded at a visit, 
both the TL and NTL visit response will be recorded as NA and the overall visit response will be 
no evidence of disease (NED). If a new lesion is observed then the overall visit response will be 
PD. Appendix Table 1 summarizes overall visit response given the visit responses from TL and 
NTL are combined with new lesion.
Appendix Table 1.
Overall Visit Response
Target lesions
Non-target lesions
New lesions
Overall response
CR
CR or NA
No
CR
CR
Non CR/Non PD or NE
No
PR
PR
Non PD or NE or NA
No
PR
SD 
Non PD or NE or NA
No
SD
NE
Non PD or NE or NA
No
NE
PD
Any
Any
PD
Any
PD
Any
PD
Any
Any
Yes
PD
NA
CR
No
CR
NA
Non CR/Non PD
No
SD
NA
NE
No
NE
NA
NA
No
NED
CR  Complete response, NA  Not applicable, PR  Partial response, SD  Stable disease, PD  Progression of disease, NE  Not 
evaluable, NED No evidence of disease.


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Appendix 2.
Overview of EORTC QLQ-C30 and Questionnaire 
The EORTC QLQ-C30 is a well-validated questionnaire commonly used in oncology trials. It 
consists of 30 items, which address 15 HRQoL domains: five multi-item functional scales, three 
multi-item symptom scales, a global health status/QoL scale, and six single-item symptom scales 
(Appendix Table 2). 
Appendix Table 2.
Overview of EORTC QLQ-C30 (Version 3)
EORTC QLQ-C30 Domains
Number of Items
Item Range
Item Numbers (Version 3)
Global health status/QoL
2
1–7
29, 30
Functional Domains
Physical functioning
5
1–4
1–5
Role functioning
2
1–4
6, 7
Emotional functioning
4
1–4
21–24
Cognitive functioning
2
1–4
20, 25
Social functioning
2
1–4
26, 27
Symptom and Financial Difficulty Domains
Fatigue
3
1–4
10, 12, 18
Nausea and vomiting
2
1–4
14, 15
Pain
2
1–4
9, 19
Dyspnea
1
1–4
8
Insomnia
1
1–4
11
Appetite loss
1
1–4
13
Constipation
1
1–4
16
Diarrhea
1
1–4
17
Financial difficulties
1
1–4
28
Abbreviations: EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Core 30 
Questionnaire; QoL = quality of life


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ENGLISH 
EORT QLQ- 30 (vm ion 3) 
We are interested in some things about you and your health. Please answer all of the questions yourself by circling the 
number that best applies to you. There are no "right" or "wrong" answers. The information that you provide v,,j)I 
remain strict!)• confidential. 
Pleas<e fill in your initial.s: 
Your binhdate (Day, Montl1, Year): 
Today's date (Day, Month, Year): 
31 
I. 
Do you have any trouble doing strenuous activities, 
like carrying a heavy sbopping bag or a suitcase? 
2. 
Do you have any trouble taking a ]Qng walk? 
3. 
Do you have any trouble taking a shon walk out,ide of the house. 
4. 
5. 
Do you need help v,,jth eating, dressing, wa.,hin 
yourself or using the toilet? 
During the past week: 
6. 
7. 
8. 
9. 
JO. 
11. 
12. 
13. Have you lacked appetite? 
14. Have you felt nau.seated? 
15. Have you vomited? 
16. Have you been constipated? 
Please go on to the next page 
4 
4 
3 
4 
3 
4 
2 
3 
4 
Not at 
A 
Quite 
Very 
II 
Little 
a Bit 
Much 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 


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ti:NCU~H 
During the past week: 
Not at 
A 
Quite 
Very 
II 
Little 
a Bit 
Much 
17. Have you had diarrhea? 
2 
3 
4 
18. Were you tired? 
2 
3 
4 
19. Did pain interfere with your daily activities? 
2 
3 
4 
20. Have you had difficulty in concentrating on tl1ings, 
like reading a newspaper or walching television? 
4 
2 1. Did you feel tert.se? 
4 
22. Did you worry? 
4 
23. Did you feel irritable? 
4 
24. Did you feel depressed? 
3 
4 
25. Have you had difficulty remembering thing.,? 
3 
4 
26. Has your physical condilmn or medical treatmen 
interfered with your famrly life? 
2 
3 
4 
27. Has your physical condition or n 
t 
interfered with your social acllvi 
2 
3 
4 
28. 
2 
3 
4 
5 
6 
7 
Excellent 
30. 
rate your overall quality of life during the pa.st week? 
2 
4 
5 
6 
7 
Very poor 
Exce.llent 
e c,.,,,,w,i 19~ EORTCQua1,,,ut1.,r,c,....,. Arr aj,.u """"""· v ... , .. J.O 


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Appendix 3.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
Health Questionnaire 
English version for the UK 
UK (Er(Jlish) © 2009 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group 


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Under each heading, please tick the ONE box that best describes your health TODAY. 
MOBILITY 
I have no problems in walking about 
I have slight problems in walking about 
I have moderate problems in walking about 
I have severe problems in walking about 
I am unable to walk about 
SELF-CARE 
I have no problems washing or dressing myself 
I have slight problems washing or dressing myself 
I have moderate problems washing or dressing myself 
I have severe problems washing or dressing myself 
I am unable to wash or dress myself 
USUAL ACTIVITIES (e.g. work, study, housework, family or 
leisure activities) 
I have no problems doing my usual activities 
I have slight problems doing my usual activities 
I have moderate problems doing my usual activities 
I have severe problems doing my usual activities 
I am unable to do my usual activities 
PAIN / DISCOMFORT 
I have no pain or discomfort 
I have slight pain or discomfort 
I have moderate pain or discomfort 
I have severe pain or discomfort 
I have extreme pain or discomfort 
ANXIETY/ DEPRESSION 
I am not anxious or depressed 
I am slightly anxious or depressed 
I am moderately anxious or depressed 
I am severely anxious or depressed 
I am extremely anxious or depressed 
2 
UK (English) © 2009 EuroQof Group EQ-5O™ is a trade mark of the EuroQof Group 


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• 
We would like to know how good or bad your health is TODAY. 
• 
This scale is numbered from Oto 100. 
• 
100 means the best health you can imagine. 
0 means the worst health you can imagine. 
• 
Mark an X on the scale to indicate how your health is TODAY. 
• 
Now, please write the number you marked on the scale in the box 
below. 
YOURHEALTHTODAY= D 
3 
UK (English) © 2009 EuroQol Group EQ-5O™ is a trade mark of the EuroQol Group 
The best health 
you can imagine 
100 
The worst health 
you can imagine 
95 
90 
85 
80 
75 
70 
65 
60 
55 
50 
45 
40 
35 
30 
25 
20 
15 
10 
5 
0 


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Appendix 4.
FACT Colorectal Symptom Index (FCSI)
Below is a list of statements that other people with your illness have said are important. 
Please circle or mark one number per line to indicate your response as it applies to the 
past 7 days.
Not at 
all
A little 
bit
Some-
what
Quite
a bit
Very 
much
GP1
I have a lack of energy
0
1
2
3
4
GP4
I have pain
0
1
2
3
4
C2
I am losing weight
0
1
2
3
4
C5
I have diarrhea (diarrhoea)
0
1
2
3
4
GP2
I have nausea
0
1
2
3
4
C1
I have swelling or cramps in my stomach area
0
1
2
3
4
C6
I have a good appetite
0
1
2
3
4
GF3
I am able to enjoy life
0
1
2
3
4
GF7
I am content with the quality of my life right 
now
0
1
2
3
4


GS-US-587-6156 SAP
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Biostatistics eSigned
16-Jul-2024
23:57:58
Global Development
Lead (GDL) eSigned
17-Jul-2024
05:38:44
PPD
PPD-