A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Gilead Sciences

CLINICAL STUDY PROTOCOL
Study Title:
A Phase 2 Study of Magrolimab Combination Therapy in Patients 
With Head and Neck Squamous Cell Carcinoma
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
USA
IND Number:
EU CT Number:
ClinicalTrials.gov 
Identifier:
155066
2020-005708-20
NCT04854499
Indication:
Head and Neck Squamous Cell Carcinoma
Protocol ID:
GS-US-548-5916
Contact Information:
The medical monitor name and contact information will be 
provided on the Key Study Team Contact List.
Protocol Version/Date:
Original:
22 January 2021
Amendment 1:
12 March 2021
Amendment 2:
17 March 2021
Amendment 3:
16 December 2021
Amendment 4:
26 January 2022
Amendment 5:
20 September 2022
Amendment 6:
01 November 2023
This study will be conducted under United States Food and Drug Administration investigational 
new drug (IND) regulations (21 CFR Part 312); however, sites located in the European 
Economic Area, United Kingdom, and Switzerland are not included under the IND and are 
considered non-IND sites.
This study will be conducted in compliance with this protocol and in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, and that are consistent with 
International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and applicable 
regulatory requirements.
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The information contained in this document, particularly unpublished data, is the property or 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.
(rJ GILEAU 

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TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................2
LIST OF APPENDICES.................................................................................................................................................6
LIST OF IN-TEXT TABLES .........................................................................................................................................6
LIST OF IN-TEXT FIGURES........................................................................................................................................7
PROTOCOL SYNOPSIS................................................................................................................................................8
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS ....................................................................27
1.
INTRODUCTION................................................................................................................................................30
1.1.
Background..............................................................................................................................................30
1.1.1.
Background on Head and Neck Squamous Cell Carcinoma.................................................30
1.2.
Magrolimab .............................................................................................................................................31
1.2.1.
General Information ..............................................................................................................31
1.2.2.
Nonclinical Pharmacology and Toxicology ..........................................................................32
1.2.3.
Clinical Background for Magrolimab ...................................................................................33
1.3.
Information About Pembrolizumab, Zimberelimab, 5-Fluorouracil, Platinum (Cisplatin or 
Carboplatin), and Docetaxel....................................................................................................................37
1.3.1.
Description of Pembrolizumab..............................................................................................37
1.3.2.
Description of Zimberelimab ................................................................................................37
1.3.3.
Description of 5-Fluorouracil................................................................................................37
1.3.4.
Description of Cisplatin.........................................................................................................37
1.3.5.
Description of Carboplatin ....................................................................................................37
1.3.6.
Description of Docetaxel.......................................................................................................38
1.3.7.
Clinical Data for Pembrolizumab..........................................................................................38
1.3.8.
Clinical Data for Zimberelimab.............................................................................................38
1.3.9.
Clinical Data for Pembrolizumab in Combination With 5-Fluorouracil 
and Platinum (Cisplatin or Carboplatin) Chemotherapy.......................................................39
1.3.10.
Clinical Data for Docetaxel...................................................................................................40
1.3.11.
Information on Study Auxiliary Medicinal Products/Noninvestigational 
Medicinal Products................................................................................................................40
1.4.
Rationale for This Study..........................................................................................................................40
1.5.
Rationale for Dose Selection...................................................................................................................42
1.5.1.
Magrolimab ...........................................................................................................................42
1.5.2.
Zimberelimab ........................................................................................................................43
1.6.
Risk/Benefit Assessment for the Study ...................................................................................................43
1.7.
Compliance..............................................................................................................................................45
2.
OBJECTIVES AND ENDPOINTS......................................................................................................................46
3.
STUDY DESIGN.................................................................................................................................................48
3.1.
Study Design ...........................................................................................................................................48
3.1.1.
Safety Run-in.........................................................................................................................49
3.1.2.
Phase 2 Cohorts .....................................................................................................................56
3.1.3.
Diagnostic Tissue Testing .....................................................................................................57
3.2.
Study Treatments.....................................................................................................................................57
3.2.1.
Safety Run-in 1, Pre-expansion Safety Run-in for Magrolimab + 
Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2 .............................................57
3.2.2.
Safety Run-in 2 and Phase 2 Cohort 3...................................................................................60
3.3.
Duration of Treatment .............................................................................................................................61
3.4.
Discontinuation Criteria ..........................................................................................................................62
3.5.
Discontinuation From Study Criteria/End of Study ................................................................................63
3.6.
Poststudy Care.........................................................................................................................................63
3.7.
Source Data .............................................................................................................................................63

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3.8.
Biomarker Samples to Address the Study Objectives.............................................................................63
4.
PATIENT POPULATION ...................................................................................................................................66
4.1.
Number of Patients and Patient Selection ...............................................................................................66
4.1.1.
Patient Replacement ..............................................................................................................66
4.2.
Inclusion Criteria.....................................................................................................................................66
4.3.
Exclusion Criteria....................................................................................................................................68
5.
INVESTIGATIONAL MEDICINAL PRODUCTS.............................................................................................72
5.1.
Randomization, Blinding, and Treatment Codes Access ........................................................................72
5.1.1.
Randomization.......................................................................................................................72
5.1.2.
Blinding .................................................................................................................................72
5.2.
Description and Handling of Magrolimab...............................................................................................72
5.2.1.
Formulation ...........................................................................................................................72
5.2.2.
Packaging and Labeling ........................................................................................................72
5.2.3.
Storage and Handling ............................................................................................................72
5.3.
Description and Handling of Pembrolizumab .........................................................................................73
5.3.1.
Formulation ...........................................................................................................................73
5.3.2.
Packaging and Labeling ........................................................................................................73
5.3.3.
Storage and Handling ............................................................................................................73
5.4.
Description and Handling of Zimberelimab............................................................................................73
5.4.1.
Formulation ...........................................................................................................................73
5.4.2.
Packaging and Labeling ........................................................................................................73
5.4.3.
Storage and Handling ............................................................................................................73
5.5.
Description and Handling of 5-Fluorouracil ...........................................................................................74
5.5.1.
Formulation ...........................................................................................................................74
5.5.2.
Packaging and Labeling ........................................................................................................74
5.5.3.
Storage and Handling ............................................................................................................74
5.6.
Description and Handling of Cisplatin....................................................................................................74
5.6.1.
Formulation ...........................................................................................................................74
5.6.2.
Packaging and Labeling ........................................................................................................74
5.6.3.
Storage and Handling ............................................................................................................74
5.7.
Description and Handling of Carboplatin................................................................................................74
5.7.1.
Formulation ...........................................................................................................................74
5.7.2.
Packaging and Labeling ........................................................................................................75
5.7.3.
Storage and Handling ............................................................................................................75
5.8.
Description and Handling of Docetaxel ..................................................................................................75
5.8.1.
Formulation ...........................................................................................................................75
5.8.2.
Packaging and Labeling ........................................................................................................75
5.8.3.
Storage and Handling ............................................................................................................75
5.9.
Dosage and Administration of Magrolimab............................................................................................75
5.9.1.
Dose Modifications and Delays for Magrolimab ..................................................................76
5.9.2.
Magrolimab Premedication and Prophylaxis ........................................................................78
5.10.
Dosage and Administration of Pembrolizumab ......................................................................................78
5.10.1.
Dose Modifications for Pembrolizumab ...............................................................................78
5.11.
Dosage and Administration of Zimberelimab .........................................................................................78
5.11.1.
Dose Modifications for Zimberelimab ..................................................................................79
5.12.
Dosage and Administration of 5-Fluorouracil.........................................................................................79
5.12.1.
Dose Modifications for 5-Fluorouracil..................................................................................79
5.13.
Dosage and Administration of Platinum (Cisplatin or Carboplatin).......................................................81
5.13.1.
Dose Modifications for Platinum (Cisplatin or Carboplatin)................................................81
5.14.
Dosage and Administration of Docetaxel................................................................................................83
5.14.1.
Dose Modifications for Docetaxel.........................................................................................83
5.14.2.
Docetaxel Premedication and Prophylaxis............................................................................85
5.15.
Prior and Concomitant Medications........................................................................................................85
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5.15.1.
Permitted Concomitant Medications .....................................................................................85
5.15.2.
Prohibited Concomitant Medications....................................................................................86
5.16.
Timing of Dose Administration...............................................................................................................86
5.17.
Accountability for Investigational Medicinal Product ............................................................................86
5.17.1.
Investigational Medicinal Product Return or Disposal .........................................................87
6.
STUDY PROCEDURES......................................................................................................................................88
6.1.
Patient Enrollment and Treatment Assignment.......................................................................................88
6.2.
Pretreatment Assessments .......................................................................................................................88
6.2.1.
Screening Visit ......................................................................................................................88
6.3.
Randomization.........................................................................................................................................89
6.4.
Treatment Assessments ...........................................................................................................................89
6.4.1.
Pregnancy Test ......................................................................................................................89
6.4.2.
Type and Screen and Direct Antiglobulin Test .....................................................................90
6.4.3.
Vital Signs .............................................................................................................................90
6.4.4.
Physical Examination ............................................................................................................90
6.4.5.
Performance Status................................................................................................................90
6.4.6.
Electrocardiograms................................................................................................................90
6.4.7.
Patient-Reported Outcomes...................................................................................................90
6.4.8.
Adverse Events......................................................................................................................91
6.4.9.
Concomitant Medications......................................................................................................91
6.5.
Safety Assessments .................................................................................................................................92
6.6.
Efficacy Assessments ..............................................................................................................................93
6.7.
Pharmacokinetic Assessments.................................................................................................................94
6.8.
Immunogenicity (Antidrug Antibodies)..................................................................................................94
6.9.
Biomarker Assessments...........................................................................................................................94
6.10.
Posttreatment Assessments......................................................................................................................95
6.11.
Assessments for Early Discontinuation From Study Treatment .............................................................95
6.11.1.
Criteria for Discontinuation of Study Treatment...................................................................96
6.12.
Criteria for Discontinuation From Study/End of Study ..........................................................................96
6.13.
Poststudy Care.........................................................................................................................................96
6.14.
Sample Storage........................................................................................................................................96
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT................................................................................97
7.1.
Definitions of Adverse Events and Serious Adverse Events...................................................................97
7.1.1.
Adverse Events......................................................................................................................97
7.1.2.
Serious Adverse Events.........................................................................................................97
7.1.3.
Study Drugs and Gilead Concomitant Therapy Special Situations Reports .........................98
7.2.
Assessment of Adverse Events and Serious Adverse Events..................................................................99
7.2.1.
Assessment of Causality for Study Drugs and Procedures ...................................................99
7.2.2.
Assessment of Severity........................................................................................................100
7.3.
Investigator Reporting Requirements and Instructions .........................................................................100
7.3.1.
Requirements for Collection Prior to Study Drug Initiation ...............................................100
7.3.2.
Adverse Events....................................................................................................................100
7.3.3.
Serious Adverse Events.......................................................................................................100
7.3.4.
Study Drug Special Situations Reports ...............................................................................100
7.3.5.
Concomitant Therapy Reports.............................................................................................101
7.4.
Reporting Process for Serious Adverse Events and Special Situation Reports.....................................101
7.4.1.
Serious Adverse Event Reporting Process ..........................................................................101
7.4.2.
Special Situations Reporting Process ..................................................................................102
7.5.
Gilead Reporting Requirements ............................................................................................................103
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events.........................................................................................................................104
7.7.
Abnormal Liver Function Tests.............................................................................................................104
7.8.
Toxicity Management............................................................................................................................105
7.8.1.
Magrolimab .........................................................................................................................105

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7.8.2.
Pembrolizumab....................................................................................................................110
7.8.3.
Zimberelimab ......................................................................................................................113
7.8.4.
5-Fluorouracil......................................................................................................................115
7.8.5.
Cisplatin...............................................................................................................................115
7.8.6.
Carboplatin ..........................................................................................................................115
7.8.7.
Docetaxel.............................................................................................................................115
8.
STATISTICAL CONSIDERATIONS...............................................................................................................116
8.1.
Analysis Objectives and Endpoints.......................................................................................................116
8.1.1.
Analysis Objectives.............................................................................................................116
8.2.
Planned Analyses...................................................................................................................................116
8.2.1.
Safety Analysis....................................................................................................................116
8.2.2.
Efficacy Analysis.................................................................................................................116
8.2.3.
Final Analysis......................................................................................................................116
8.3.
Analysis Conventions............................................................................................................................116
8.3.1.
Analysis Sets .......................................................................................................................116
8.3.2.
Data Handling Conventions ................................................................................................118
8.4.
Demographic and Baseline Characteristics Analysis............................................................................118
8.5.
Efficacy Analysis...................................................................................................................................119
8.5.1.
Primary Efficacy Endpoint Analyses ..................................................................................119
8.5.2.
Secondary Efficacy Endpoint Analyses ..............................................................................119
8.6.
Safety Analysis......................................................................................................................................119
8.6.1.
Primary Safety Endpoint Analysis ......................................................................................119
8.6.2.
Other Safety Analysis..........................................................................................................120
8.6.3.
Extent of Exposure ..............................................................................................................120
8.6.4.
Adverse Events....................................................................................................................120
8.6.5.
Laboratory Evaluations .......................................................................................................120
8.6.6.
Other Safety Evaluations.....................................................................................................121
8.7.
Pharmacokinetic Analysis .....................................................................................................................121
8.8.
Immunogenicity Analysis......................................................................................................................121
8.9.
Biomarker Analysis...............................................................................................................................121
8.10.
Analysis of Patient-Reported Outcome Data ........................................................................................121
8.11.
Sample Size ...........................................................................................................................................121
9.
RESPONSIBILITIES.........................................................................................................................................123
9.1.
Investigator Responsibilities .................................................................................................................123
9.1.1.
Good Clinical Practice.........................................................................................................123
9.1.2.
Financial Disclosure ............................................................................................................123
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval..............................................................................................................................123
9.1.4.
Informed Consent ................................................................................................................123
9.1.5.
Confidentiality.....................................................................................................................124
9.1.6.
Study Files and Retention of Records .................................................................................124
9.1.7.
Case Report Forms ..............................................................................................................125
9.1.8.
Investigator Inspections.......................................................................................................126
9.1.9.
Protocol Compliance ...........................................................................................................126
9.2.
Sponsor Responsibilities .......................................................................................................................126
9.2.1.
Protocol Modifications ........................................................................................................126
9.2.2.
Study Report and Publications ............................................................................................126
9.3.
Joint Investigator/Sponsor Responsibilities ..........................................................................................126
9.3.1.
Payment Reporting ..............................................................................................................126
9.3.2.
Access to Information for Monitoring.................................................................................127
9.3.3.
Access to Information for Auditing or Inspections .............................................................127
9.3.4.
Study Discontinuation .........................................................................................................127
10.
REFERENCES...................................................................................................................................................128

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11.
APPENDICES....................................................................................................................................................133
LIST OF APPENDICES
Appendix 1.
Investigator Signature Page...................................................................................................134
Appendix 2.
Schedules of Assessments .....................................................................................................135
Appendix 3.
Pandemic Risk Assessment and Mitigation Plan ..................................................................141
Appendix 4.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities ........................................................................................................................145
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements..................................................................................................146
Appendix 6.
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire – Core Questionnaire (EORTC QLQ-C30)....................................................150
Appendix 7.
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire – Head and Neck Module (EORTC QLQ-H&N35).......................................151
Appendix 8.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L).................................................152
Appendix 9.
Eastern Cooperative Oncology Group (ECOG) Performance Status....................................155
Appendix 10.
Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1) ...............................156
Appendix 11.
Adapted Immune-Related Response Evaluation Criteria in Solid Tumors 
(irRECIST) Criteria ...............................................................................................................157
Appendix 12.
Country-Specific Considerations...........................................................................................158
Appendix 13.
Authorization Status of Study Interventions .........................................................................160
Appendix 14.
Amendment History ..............................................................................................................161
LIST OF IN-TEXT TABLES
Table 1.
Study Objectives and Endpoints..............................................................................................46
Table 2.
Safety Run-in 1: Dose De-escalation.......................................................................................58
Table 3.
Phase 2 Cohort 1: Dose Level and Schedule...........................................................................59
Table 4.
Pre-expansion Safety Run-in for Magrolimab + Pembrolizumab: Dose De-
escalation .................................................................................................................................60
Table 5.
Phase 2 Cohort 2: Dose Level and Schedule...........................................................................60
Table 6.
Safety Run-in 2: Dose De-escalation.......................................................................................61
Table 7.
Phase 2 Cohort 3: Dose Level and Schedule...........................................................................61
Table 8.
Repriming Guidelines for Magrolimab ...................................................................................77
Table 9.
Magrolimab Dosing Guidance for Planned Surgical Procedures on Study.............................77
Table 10.
5-Fluorouracil Dose Modification Levels ...............................................................................79
Table 11.
5-Fluorouracil Dose Modification Guidelines for Febrile Neutropenia or 
Documented Infection .............................................................................................................79
Table 12.
5-Fluorouracil Dose Modification Guidelines for Drug-Related Adverse Events..................80
Table 13.
Platinum Dose Modification Levels........................................................................................82
Table 14.
Platinum Dose Modification Guidelines for Febrile Neutropenia or Documented 
Infection...................................................................................................................................82
Table 15.
Platinum Dose Modification Guidelines for Drug-Related Adverse Events...........................82
Table 16.
Docetaxel Dose Modification Guidelines for Neutropenia .....................................................84
Table 17.
Docetaxel Dose Modification Guidelines for Hepatic Toxicity..............................................84
Table 18.
Docetaxel Dose Modification Guidelines for Other Grade 3 or 4 Toxicities..........................85
Table 19.
Screening Laboratory Analytes ...............................................................................................92
Table 20.
Study Laboratory Analytes (To Be Performed During the Study)..........................................93
Table 21.
Management of Infusion-Related Reactions .........................................................................107
Table 22.
Pneumonitis Management Algorithm....................................................................................109
Table 23.
Pembrolizumab Dose Modification and Toxicity Management Guidelines .........................111
Table 24.
Treatment Modifications and Toxicity Management for Zimberelimab...............................113

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LIST OF IN-TEXT FIGURES
Figure 1.
Effect of Magrolimab on Anemia and Mitigation with a Priming/Maintenance 
Dosing Regimen ......................................................................................................................35
Figure 2.
Study Schema ..........................................................................................................................49

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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Study Title:
A Phase 2 Study of Magrolimab Combination Therapy in Patients With 
Head and Neck Squamous Cell Carcinoma
IND Number:
EU CT Number:
ClinicalTrials.gov 
Identifier:
155066
2020-005708-20
NCT04854499
Study Centers 
Planned:
Approximately 100 centers globally
Objectives and 
Endpoints:
Primary Objectives
Primary Endpoints
Safety Run-in:
•
To evaluate the safety, tolerability, 
and recommended Phase 2 dose 
(RP2D) of magrolimab in 
combination with the following:

Pembrolizumab + platinum + 
5-fluorouracil (5-FU)

Docetaxel
Phase 2 Cohorts:
•
To evaluate the progression-free 
survival (PFS) with magrolimab in 
combination with pembrolizumab + 
platinum + 5-FU versus 
pembrolizumab + platinum + 5-FU 
as determined by investigator 
assessment (Phase 2 Cohort 1)
•
To evaluate the efficacy of 
magrolimab in combination with 
pembrolizumab, if this optional 
cohort is opened, and magrolimab 
in combination with docetaxel as 
determined by the 
investigator-assessed objective 
response rate (ORR) (Phase 2 
Cohorts 2 and 3)
Safety Run-in:
•
Incidence of adverse events (AEs) 
and laboratory abnormalities 
defined as dose-limiting toxicities 
(DLTs) according to the National 
Cancer Institute (NCI) Common 
Terminology Criteria for Adverse 
Events (CTCAE), Version 5.0
Phase 2 Cohorts:
•
PFS, defined as the time from the 
date of randomization until the 
earliest date of documented disease 
progression, as determined by 
investigator assessment, or death 
from any cause, whichever occurs 
first (Phase 2 Cohort 1, Arm A 
versus Arm B)
•
ORR, defined as the proportion of 
patients who achieve a 
complete response (CR) or partial 
response (PR) as measured by 
Response Evaluation Criteria in 
Solid Tumors (RECIST) 
Version 1.1, as determined by 
investigator assessment 
(Phase 2 Cohorts 2 and 3)

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Secondary Objectives
Secondary Endpoints
Safety Run-in:
•
To evaluate the pharmacokinetics 
(PK) and immunogenicity of 
magrolimab in combination with 
anticancer therapies
Phase 2 Cohorts:
•
To evaluate PFS for magrolimab + 
zimberelimab + platinum + 5-FU 
versus pembrolizumab + platinum 
+ 5-FU as determined by 
investigator assessment (Phase 2 
Cohort 1)
•
To evaluate ORR as determined by 
investigator assessment (Phase 2 
Cohort 1)
•
To evaluate PFS by investigator 
assessment (Phase 2 Cohorts 2 and 
3)
•
To evaluate additional measures of 
efficacy, including duration of 
response (DOR) and overall 
survival (OS)
•
To evaluate the PK and 
immunogenicity of magrolimab in 
combination with anticancer 
therapies
•
To evaluate patient-reported 
outcomes (PROs)/quality-of-life 
measures
Safety Run-in:
•
Magrolimab concentration versus 
time and antidrug antibodies 
(ADAs) to magrolimab
Phase 2 Cohorts:
•
PFS as determined by investigator 
assessment or death from any 
cause, whichever occurs first 
(Phase 2 Cohort 1, Arm C versus 
concurrent Arm B)
•
ORR as determined by investigator 
assessment (Phase 2 Cohort 1)
•
PFS from date of dose initiation 
(Phase 2 Cohort 2 and Phase 2 
Cohort 3) until 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
•
DOR, defined as time from first 
documentation of CR or PR to the 
earliest date of documented disease 
progression or death from any 
cause, whichever occurs first
•
OS, defined as time from date of 
randomization (Phase 2 Cohort 1) 
or date of dose initiation (Phase 2 
Cohort 2 and Phase 2 Cohort 3) to 
death from any cause
•
Magrolimab concentration versus 
time and ADAs to magrolimab
•
PRO assessment (European 
Organisation for Research and 
Treatment of Cancer Quality of 
Life Questionnaire Core - 
Questionnaire [EORTC QLQ-C30], 
European Organisation for 
Research and Treatment of Cancer 
Quality of Life - Head and Neck 
Module [EORTC QLQ-H&N35], 
and 5 level – EuroQol - 5 
dimensions questionnaire [EQ-5D-
5L]) scores
CCI

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Study Design:
This is a Phase 2, open-label, multicenter study evaluating magrolimab 
in combination with pembrolizumab + platinum + 5-FU chemotherapy; 
magrolimab in combination with pembrolizumab; magrolimab in 
combination with zimberelimab + platinum + 5-FU chemotherapy in 
patients with untreated metastatic or unresectable, locally recurrent head 
and neck squamous cell carcinoma (HNSCC); and magrolimab in 
combination with docetaxel in patients with locally advanced/metastatic 
HNSCC (mHNSCC) who were previously treated with at least 1 and no 
more than 2 lines of prior systemic therapy.
This study will consist of the following 2 safety run-in evaluations:
•
Safety Run-in 1: magrolimab + pembrolizumab + platinum + 5-FU 
in patients with untreated metastatic or unresectable, locally 
recurrent HNSCC regardless of programmed cell death ligand 1 
(PD-L1) status
•
Safety Run-in 2: magrolimab + docetaxel in patients with locally 
advanced/mHNSCC regardless of PD-L1 status who were 
previously treated with at least 1 and no more than 2 lines of prior 
systemic therapy
Additionally, a pre-expansion safety run-in evaluation of magrolimab + 
pembrolizumab in patients with untreated metastatic or unresectable, 
locally recurrent HNSCC with a PD-L1 combined positive score (CPS) 
≥ 1 may be conducted at the sponsor’s discretion prior to the initiation of 
the optional Phase 2 cohort of magrolimab + pembrolizumab.
Once the Safety Review Team (SRT) reviews the safety for patients in 
each run-in and the sponsor determines the RP2D for that cohort, the 
following Phase 2 cohorts will be conducted:
•
Phase 2 Cohort 1: a randomized, open-label cohort of magrolimab 
+ pembrolizumab + platinum + 5-FU (Arm A) versus 
pembrolizumab + platinum + 5-FU (Arm B) versus a delayed open 
arm magrolimab + zimberelimab + platinum + 5-FU (Arm C) in 
patients with untreated metastatic or unresectable, locally recurrent 
HNSCC regardless of PD-L1 status
•
Optional Phase 2 Cohort 2: a cohort of magrolimab + 
pembrolizumab in patients with untreated metastatic or unresectable, 
locally recurrent HNSCC with a PD-L1 CPS ≥ 1
CCI

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•
Phase 2 Cohort 3: a cohort of magrolimab + docetaxel in patients 
with locally advanced/mHNSCC regardless of PD-L1 status who 
were previously treated with at least 1 and no more than 2 lines of 
prior systemic therapy
The study schematic is provided below.
5-FU = 5-fluorouracil; HNSCC = head and neck squamous cell carcinoma; PD-L1 = programmed 
cell death ligand 1; RP2D = recommended Phase 2 dose
a
Optional cohort to be opened at the discretion of the sponsor.
b
A pre-expansion safety run-in evaluation of magrolimab + pembrolizumab may be 
conducted at the sponsor’s discretion prior to the initiation of this optional cohort.
Safety Run-in 1:
A DLT evaluation period of 1 cycle (21 days) will occur. After 
6 patients have completed the DLT evaluation period, a decision will be 
made on further expansion or dose de-escalation.
Even though no dose-dependent toxicities have been observed with 
magrolimab, in order to preserve the efficacious doses of the 
combination partner drugs, dose de-escalation will take place for 
magrolimab. Dose de-escalation decisions will be made as follows:
•
If no more than 2 of 6 DLT-evaluable patients experience a DLT in 
Cycle 1, enrollment into Phase 2 Cohorts 1 and 2 will begin at this 
dose level.
•
If 3 or more (> 34%) DLT-evaluable patients experience a DLT at 
any time, another 6 patients will be enrolled at a lower dose and will 
be evaluated in the same manner to define the recommended dose 
for the combination regimen.
Untreated 
metastatic or 
unresectable, 
locally 
recurrent 
HNSCC 
Untreated 
metastatic or 
unresectable, 
locally 
recurrent 
HNSCC 
(PDL 1 + only} 
Metastatic or 
unresectable 
HNSCC 
previously 
treated with 1 
and no more 
than 2 lines of 
prior therapy 
Safety Run-in 1 
Magrolimab + 
Pembrolizumab + Platinum 
+ 5-FU 
N = up to 18 
Optional Phase 2 
Cohort 2•,b (single-arm) 
Safety 
evaluation 
& RP2D 
Safety Run-in 2 
Magrolimab 
+ Docetaxel 
N= upto1 8 
Safety 
evaluation 
& RP2D 
Phase 2 
Cohort 3 (single-arm) 
Magrolimab 
+ Docetaxel 
N = 40 
Phase 2 
Cohort 1 (randomized) 
Arm A: Magrolimab + 
Pembrolizumab + Platinum + 
5-FU 
N = 66 
Arm B: Pembrolizumab + 
Platinum + 5-FU 
N = 66 
Arm C: Magrolimab + 
Zimberelimab + Platinum + 
5-FU 
N = 46 

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Pre-expansion Safety Run-in for Magrolimab + Pembrolizumab (if 
Applicable): At the discretion of the sponsor, 6 patients may be initially 
enrolled to receive magrolimab + pembrolizumab in this pre-expansion 
run-in evaluation. Dose evaluation and possible de-escalation will be 
performed as described for Safety Run-in 1.
Safety Run-in 2: Safety Run-in 2 will open for enrollment at the same 
time as Safety Run-in 1. A DLT evaluation period of 1 cycle (21 days) 
will occur. After 6 patients have completed the DLT evaluation period, 
a decision will be made on further expansion or dose de-escalation. The 
same design and DLT rules will apply to Safety Run-in 2.
DLT Assessment Period: The DLT assessment period will be the first 
cycle (21 days) and applies to each safety run-in. Patients will be 
considered evaluable for assessment of DLTs if either of the following 
criteria is met during the DLT assessment period:
•
The patient experiences a DLT at any time after initiation of the first 
infusion of magrolimab.
•
The patient does not experience a DLT and completes at least 
2 infusions of magrolimab and at least 1 dose of pembrolizumab, 
1 dose of platinum, and 1 dose of 5-FU for Safety Run-in 1; at least 1 
dose of docetaxel for Safety Run-in 2; and at least 1 dose of 
pembrolizumab for the pre-expansion safety run-in for magrolimab + 
pembrolizumab (if applicable).
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 evaluations will be replaced.
The DLT definition is provided in the study protocol.
Patients enrolled in the safety run-in evaluations will continue treatment 
until unacceptable toxicity or radiographic disease progression, 
whichever occurs first, and will not change their magrolimab dose level 
after the RP2D is determined.
Phase 2 Cohort 1 (n = 178): Once the SRT reviews Safety Run-in 1 
and the sponsor determines the RP2D for magrolimab + pembrolizumab 
+ 5-FU + platinum, a Phase 2, randomized, open-label cohort with a 
2-treatment-group design will open for enrollment. Approximately 
132 patients with untreated metastatic or unresectable, locally recurrent 
HNSCC regardless of PD-L1 status will be randomized in a 1:1 ratio to 
receive either magrolimab + pembrolizumab + platinum + 5-FU (Arm 
A) or pembrolizumab + platinum + 5-FU (Arm B). The primary efficacy 
assessment will be PFS as determined by investigator assessment, with 
the primary analysis to occur after 93 events. Stratification factors for 
randomization include the following: 1) PD-L1 expression (CPS ≥ 1 
versus CPS < 1) and 2) p16 status (positive versus negative).

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Once the Phase 2 Cohort 1 enrolls 20 patients in each Arm A and 
Arm B, a third arm will open: magrolimab + zimberelimab + platinum + 
5-FU (Arm C; n = 46). Randomization will continue 1:1:1 across all 
3 arms, with the stratification factors 1) PD-L1 expression (CPS ≥ 1 
versus CPS < 1) and 2) p16 status (positive versus negative).
Phase 2 Cohort 2 (n = 25): Approximately 25 patients with untreated 
metastatic or unresectable, locally recurrent HNSCC with a PD-L1 CPS 
≥ 1 may be enrolled to receive magrolimab + pembrolizumab in the 
optional Phase 2 Cohort 2. The primary efficacy assessment will be 
investigator assessed ORR.
Phase 2 Cohort 3 (n = 40): Once the SRT reviews Safety Run-in 2 and 
the sponsor determines the RP2D for magrolimab + docetaxel, Phase 2 
Cohort 3 will open for enrollment. Approximately 40 patients with 
locally advanced/mHNSCC regardless of PD-L1 status who were 
previously treated with at least 1 and no more than 2 lines of prior 
systemic therapy will be enrolled to receive magrolimab + docetaxel. 
The primary efficacy assessment will be investigator-assessed ORR.
Pharmacokinetic and Antidrug Antibody Testing: Pharmacokinetic 
(serum) and ADA (peripheral blood) analyses will be performed for 
patients who receive treatment with magrolimab or zimberelimab.
Diagnostic Tissue Testing: Tumor expression of PD-L1 will be 
evaluated prospectively using an assay approved by the Food and Drug 
Administration for detection of PD-L1 in HNSCC tissues. Testing for 
p16 human papillomavirus (HPV) positivity will be performed by 
immunohistochemistry analysis. Oral cavity, hypopharynx, and larynx 
cancers are not required to undergo HPV testing by 
immunohistochemistry, as by convention they are assumed to be HPV 
negative. 
Number of 
Patients Planned:
Approximately 230 patients in total and up to 297:
•
Safety Run-in 1 and 2: at least 12 and up to 36 patients in total
•
Optional pre-expansion safety run-in for Cohort 2: possibly 6 
patients and up to 18 in total
•
Phase 2 Cohort 1: approximately 178 patients
•
Phase 2 Cohort 2 (optional): approximately 25 patients
•
Phase 2 Cohort 3: approximately 40 patients
Target Population: Phase 2 Cohort 1: Patients previously untreated for metastatic or 
unresectable, locally recurrent HNSCC regardless of PD-L1 status
Phase 2 Cohort 2: Patients previously untreated for metastatic or 
unresectable, locally recurrent HNSCC with a PD-L1 CPS ≥ 1
Phase 2 Cohort 3: Patients with locally advanced/mHNSCC regardless 
of PD-L1 status who were previously treated with at least 1 and no more 
than 2 lines of prior systemic therapy

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Duration of 
Treatment:
Cycle length is 21 days for all cohorts. All patients will continue on 
study treatment unless they meet study treatment discontinuation 
criteria.
Diagnosis and 
Main Eligibility 
Criteria:
Inclusion Criteria:
All Patients
1) Patient has provided informed consent.
2) Patient is willing and able to comply with clinic visits and 
procedures outlined in the study protocol.
3) Male or female ≥ 18 years of age.
4) Eastern Cooperative Oncology Group (ECOG) performance status 
of ≤ 1.
5) Laboratory measurements, blood counts:
a) Hemoglobin must be ≥ 9 g/dL prior to initial dose of study 
treatment. Red blood cell transfusions are allowed to meet 
hemoglobin eligibility within limits set per Exclusion 
Criterion #6.
b) Absolute neutrophil count ≥ 1.5  109/L
c) Platelets ≥ 100  109/L
6) Laboratory measurements, renal function:
a) Serum creatinine ≤ 1.5  upper limit of normal (ULN) or if 
elevated, a calculated glomerular filtration rate 
> 40 mL/min/1.73 m2
7) Laboratory measurements, hepatic function:
a) Aspartate aminotransferase and alanine aminotransferase ≤ 2.5  
ULN or ≤ 5  ULN in patients with liver metastases
b) Total bilirubin ≤ 1.5  ULN or ≤ 3.0  ULN and primarily 
unconjugated if patient has a documented history of Gilbert’s 
syndrome or genetic equivalent
8) Laboratory measurements, coagulation function:
a) International normalized ratio or prothrombin time (PT) ≤ 1.5  
ULN unless patient is receiving anticoagulation therapy, as long 
as PT or partial thromboplastin time (PTT) is within therapeutic 
range of intended use for anticoagulants
b) Activated partial thromboplastin time or PTT ≤ 1.5  ULN 
unless patient is receiving anticoagulation therapy, as long as PT 
or PTT is within therapeutic range of intended use for 
anticoagulants
9) Pretreatment blood cross-match completed.

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10) Male and female patients of childbearing potential who engage in 
heterosexual intercourse must agree to use protocol-specified 
method(s) of contraception.
11) Measurable disease according to RECIST, Version 1.1.
12) Note: Inclusion Criterion #12 was removed in Protocol 
Amendment 3 and relocated to Inclusion Criterion #13d.
Safety Run-in 1, Pre-expansion Safety Run-in for Magrolimab + 
Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2
In addition to meeting the inclusion criteria for all patients, patients who 
are enrolled into Safety Run-in 1, the pre-expansion safety run-in for 
magrolimab + pembrolizumab (if applicable), and Phase 2 Cohorts 1 
and 2 must fulfill the following cohort-specific inclusion criterion:
13) Patients with histologically or cytologically confirmed metastatic or 
locally recurrent HNSCC that is considered incurable by local 
therapies
a) Patients should not have had prior systemic therapy administered 
in the recurrent or metastatic setting. Systemic therapy that was 
completed more than 6 months prior to signing consent if given 
as part of multimodal treatment for locally advanced disease is 
allowed.
b) Eligible primary tumor locations include oropharynx, oral 
cavity, hypopharynx, and larynx.
c) Patients may not have a primary tumor site of nasopharynx (any 
histology).
d) Patients must be willing to provide baseline tumor tissue from a 
core or excisional biopsy (fine needle aspirate is not adequate). 
A newly obtained biopsy (within 90 days prior to study 
treatment start) is strongly preferred, but an archival sample is 
acceptable. For archival samples submitted in lieu of newly 
obtained biopsies, tissue collected within 6 months prior to study 
treatment start is strongly preferred whenever possible. Patients 
will also be requested to consent to a mandatory on-treatment 
tumor biopsy, unless not feasible as determined by the 
investigator and discussed with the sponsor.
Safety Run-in 1 and Phase 2 Cohort 1
In addition to meeting the inclusion criteria for all patients, patients who 
are enrolled into Safety Run-in 1 and Phase 2 Cohort 1 must fulfill the 
following cohort-specific inclusion criterion:
14) Patients with HNSCC per Inclusion Criterion #13 regardless of 
PD-L1 status

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Pre-expansion Safety Run-in for Magrolimab + Pembrolizumab (if 
Applicable) and Phase 2 Cohort 2
In addition to meeting the inclusion criteria for all patients, patients who 
are enrolled into the pre-expansion safety run-in for 
magrolimab + pembrolizumab (if applicable) and Phase 2 Cohort 2 must 
fulfill the following cohort-specific inclusion criterion:
15) Patients with HNSCC per Inclusion Criterion #13 with a PD-L1 
CPS ≥ 1
Safety Run-in 2 and Phase 2 Cohort 3
In addition to meeting the inclusion criteria for all patients, patients who 
are enrolled into Safety Run-in 2 and Phase 2 Cohort 3 must fulfill the 
following cohort-specific inclusion criterion:
16) Patients with histologically or cytologically confirmed locally 
advanced/mHNSCC regardless of PD-L1 status with at least 1 and 
no more than 2 lines of prior systemic anticancer therapy in the 
locally advanced/metastatic setting
a) Eligible primary tumor locations include oropharynx, oral 
cavity, hypopharynx, and larynx.
b) Patients may not have a primary tumor site of nasopharynx (any 
histology).
c) Prior systemic anticancer therapy for locally 
advanced/mHNSCC should consist of at least 1 line of 
platinum-based chemotherapy, with or without a PD-1 inhibitor. 
For patients with CPS ≥ 1 HNSCC, prior systemic anticancer 
therapy for locally advanced/mHNSCC should have included at 
least one line of PD-1 inhibitor-based therapy unless medically 
contraindicated.
Exclusion Criteria:
All Patients
1) Prior radiation therapy (or other nonsystemic therapy) within 
2 weeks prior to enrollment. Patients who are candidates for 
curative radiation therapy are not eligible.
2) Patient has not fully recovered (ie, ≤ Grade 1 at baseline) from AEs 
due to a previously administered treatment.
a) Note: Patients with ≤ Grade 2 neuropathy, ≤ Grade 2 alopecia, or 
laboratory values in inclusion criteria 5 through 8 are exceptions 
to this criterion and may qualify for the study.
b) Note: If a patient received major surgery, he or she must have 
recovered adequately from the toxicity and/or complications 
from the intervention prior to starting therapy.

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3) Positive serum pregnancy test (Appendix 5).
4) Breastfeeding female.
5) Active central nervous system (CNS) disease (patients with 
asymptomatic and stable, treated CNS lesions who have been off 
corticosteroids, radiation, or other CNS-directed therapy for at least 
4 weeks are not considered active).
6) Red blood cell transfusion dependence, defined as requiring more 
than 2 units of packed red blood cell transfusions during the 4-week 
period prior to screening. Red blood cell transfusions are permitted 
during the screening period and prior to enrollment to meet the 
hemoglobin inclusion criterion.
7) History of hemolytic anemia, autoimmune thrombocytopenia, or 
Evans syndrome in the last 3 months.
8) Known hypersensitivity to any of the study drugs, the metabolites, 
or formulation excipient. 
a) For Phase 2 Cohort 1, complete absence of dihydropyrimidine 
dehydrogenase (DPD) activity. If DPD status is not known, 
testing for DPD status should be done during the screening 
period where such testing is standard of care.
9) Prior treatment with cluster of differentiation 47 or signal 
regulatory protein alpha-targeting agents.
10) Prior anticancer therapy including, but not limited to, 
chemotherapy, immunotherapy, or investigational agents within 
4 weeks prior to magrolimab treatment.
11) Life expectancy of less than 3 months and/or rapidly progressing 
disease (eg, tumor bleeding, uncontrolled tumor pain) in the 
opinion of the treating investigator.
12) Diagnosis of immunodeficiency or receipt of systemic steroid 
therapy or any other form of immunosuppressive therapy within 
7 days prior to the first dose of study therapy. Corticosteroid use as 
a premedication for allergic reactions or for prophylactic 
management of AEs related to the chemotherapies specified in the 
protocol is allowed. The use of physiologic doses of corticosteroids 
may be approved with approval by the sponsor.
13) Active autoimmune disease that has required systemic treatment in 
the past 2 years (ie, use of disease-modifying agents, 
corticosteroids, or immunosuppressive drugs). Replacement 
therapy (eg, thyroxine, insulin, physiologic corticosteroid 
replacement therapy for adrenal or pituitary insufficiency) is not 
considered a form of systemic treatment.
14) Prior allogeneic tissue/solid organ transplant.

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15) History of (noninfectious) pneumonitis that required steroids or 
current pneumonitis.
16) Active, uncontrolled infection or infection requiring systemic 
therapy within ≤ 7 days of study entry.
17) Live vaccine within 30 days of start of study treatment.
18) Current participation in another interventional clinical study.
19) Known inherited or acquired bleeding disorders.
20) Significant disease or medical conditions, as assessed by the 
investigator and sponsor, that would substantially increase the risk-
benefit ratio of participating in the study. This includes, but is not 
limited to, acute myocardial infarction within the last 6 months, 
unstable angina, uncontrolled diabetes mellitus, significant active 
infections, and congestive heart failure New York Heart 
Association Class III-IV.
21) Second malignancy, except treated basal cell or localized squamous 
skin carcinomas, localized prostate cancer, or other malignancies 
for which patients are not on active anticancer therapies and who 
are in complete remission for over 5 years.
22) In patients with known history of HIV, presence of detectable viral 
load. HIV testing will be performed at screening only if required by 
local guidelines or institutional standards.
23) Known positivity for hepatitis B or C infection. Patients not 
currently on antiviral therapy and who have an undetectable viral 
load in the prior 3 months may be eligible for the study. Hepatitis B 
or C testing is not required. Patients with serologic evidence of 
prior vaccination to hepatitis B virus (ie, hepatitis B surface antigen 
negative and antibody against hepatitis B surface antigen positive) 
may participate.
Safety Run-in 1, Pre-expansion Safety Run-in for Magrolimab + 
Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2
24) Progressive disease within 6 months of completion of curatively 
intended treatment for locoregionally advanced HNSCC.
25) Prior treatment with any of the following:
a) Anti–programmed cell death protein 1 or anti–PD-L1 checkpoint 
inhibitors.
b) Anti–cytotoxic T-lymphocyte–associated protein 4 checkpoint 
inhibitors.
Safety Run-in 2 and Phase 2 Cohort 3
26) Progressive disease within 6 months of completion of curatively 
intended treatment for locally advanced/mHNSCC.
27) Prior treatment with a taxane.

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Study Procedures/
Frequency:
In Safety Run-in 1, all eligible patients will receive magrolimab + 
pembrolizumab + platinum + 5-FU. In Phase 2 Cohort 1, eligible 
patients will be randomized in a 1:1 ratio to receive either magrolimab + 
pembrolizumab + platinum + 5-FU (Arm A) or pembrolizumab + 
platinum + 5-FU (Arm B). For platinum usage, cisplatin or carboplatin 
will be used per investigator choice. Study treatments are summarized 
below.
Safety Run-in 1: Dose De-escalation
Dose Schedule 
(Day per 21-Day Cycle)
Dose 
Level
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 30 mg/kg IV (2 h ± 30 
min)
Days 8 and 
15
Days 1, 
8, and 15
—
Starting 
dose
Magrolimab 60 mg/kg IV (2 h ± 30 
min)
—
—
Day 1
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Cisplatin 100 mg/m2 IV (1 h) 
or 
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 20 mg/kg IV (2 h ± 30 
min)
Days 8 and 
15
Days 1, 
8, and 15
—
Magrolimab 45 mg/kg IV (2 h ± 30 
min)
—
—
Day 1
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Level 
minus 1
Cisplatin 100 mg/m2 IV (1 h) 
or 
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 15 mg/kg IV (2 h ± 30 
min)
Days 8 and 
15
Days 1, 
8, and 15
—
Magrolimab 30 mg/kg IV (2 h ± 30 
min)
—
—
Day 1
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Level 
minus 2
Cisplatin 100 mg/m2 IV (1 h) 
or 
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
5-FU = 5-fluorouracil; IV = intravenous

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Phase 2 Cohort 1: Dose Level and Schedule
Dose Schedule (Day per 21-Day Cycle)
Treatment 
Group
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV 
(3 h ± 30 min)
Day 1
—
—
Magrolimaba IV (2 h ± 30 min)
Days 8 and 
15
Days 1, 8, 
and 15
—
Magrolimaba IV (2 h ± 30 min)
—
—
Day 1
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day 
continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Arm A: 
Magrolimab + 
pembrolizumab 
+ platinum + 5-
FU 
Cisplatin 100 mg/m2 IV (1 h)
or
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day 
continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Arm B: 
Pembrolizumab 
+ platinum + 5-
FU 
Cisplatin 100 mg/m2 IV (1 h)
or
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
Magrolimab 1 mg/kg IV 
(3 h ± 30 min)
Day 1
—
—
Magrolimaba IV (2 h ± 30 min)
Days 8 and 
15
Days 1, 8, 
and 15
—
Magrolimaba IV (2 h ± 30 min)
—
—
Day 1
Zimberelimab 360 mg IV 
(60 min ± 15 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day 
continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Arm C: 
Magrolimab + 
Zimberelimab + 
platinum + 5-FU 
Cisplatin 100 mg/m2 IV (1 h)
or
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
5-FU = 5-fluorouracil; IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in Safety Run-in 1.
If the sponsor determines that additional dose finding for magrolimab + 
pembrolizumab is needed, an additional pre-expansion safety run-in 
evaluation may be performed. In the optional Phase 2 Cohort 2, all 
eligible patients will receive magrolimab + pembrolizumab. Study 
treatments are summarized below.

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Pre-expansion Safety Run-in for Magrolimab + Pembrolizumab: 
Dose De-escalation
Dose Schedule 
(Day per 21-Day Cycle)
Dose 
Level
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 30 mg/kg IV (2 h ± 30 min)
Days 8 
and 15
Days 1, 8, 
and 15
—
Magrolimab 60 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Starting 
dose
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 20 mg/kg IV (2 h ± 30 min)
Days 8 
and 15
Days 1, 8, 
and 15
—
Magrolimab 45 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Level 
minus 1
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 15 mg/kg IV (2 h ± 30 min)
Days 8 
and 15
Days 1, 8, 
and 15
—
Magrolimab 30 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Level 
minus 2
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
IV = intravenous
Phase 2 Cohort 2: Dose Level and Schedule
Dose Schedule 
(Day per 21-Day Cycle)
Treatment 
Group
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV 
(3 h ± 30 min)
Day 1
—
—
Magrolimaba IV 
(2 h ± 30 min)
Days 8 and 
15
Days 1, 8, 
and 15
—
Magrolimaba IV 
(2 h ± 30 min)
—
—
Day 1
Magrolimab + 
pembrolizumab
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in the pre-expansion safety run-in for magrolimab + pembrolizumab 
(if applicable).

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In the Safety Run-in 2 and Phase 2 Cohort 3, all eligible patients will 
receive magrolimab + docetaxel. Study treatments are summarized 
below.
Safety Run-in 2: Dose De-escalation
Dose Schedule 
(Day per 21-Day Cycle)
Dose 
Level
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 30 mg/kg IV (2 h ± 30 min)
Days 8 
and 15
Days 1, 8, 
and 15
—
Magrolimab 60 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Starting 
dose
Docetaxel 75 mg/m2 IV (1 h ± 5 min)
Day 1
Day 1
Day 1
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 20 mg/kg IV (2 h ± 30 min)
Days 8 
and 15
Days 1, 8, 
and 15
—
Magrolimab 45 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Level 
minus 1
Docetaxel 75 mg/m2 IV (1 h ± 5 min)
Day 1
Day 1
Day 1
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 15 mg/kg IV (2 h ± 30 min)
Days 8 
and 15
Days 1, 8, 
and 15
—
Magrolimab 30 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Level 
minus 2 
Docetaxel 75 mg/m2 IV (1 h ± 5 min)
Day 1
Day 1
Day 1
IV = intravenous
Phase 2 Cohort 3: Dose Level and Schedule
Dose Schedule 
(Day per 21-Day Cycle)
Treatment 
Group
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV 
(3 h ± 30 min)
Day 1
—
—
Magrolimaba IV (2 h ± 30 min)
Days 8 and 
15
Days 1, 8, 
and 15
—
Magrolimaba IV (2 h ± 30 min)
—
—
Day 1
Magrolimab + 
docetaxel
Docetaxel 75 mg/m2 IV 
(1 h ± 5 min)
Day 1
Day 1
Day 1
IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in Safety Run-in 2.

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Test Product, Dose, 
and Mode of 
Administration:
Safety Run-in 1 Starting Doses:
•
Magrolimab 1 mg/kg intravenous (IV) (priming dose)
•
Magrolimab 30 mg/kg IV
•
Magrolimab 60 mg/kg IV
In combination with:
•
Pembrolizumab 200 mg IV
•
5-FU 1000 mg/m2/day continuous IV
•
Cisplatin 100 mg/m2 IV or carboplatin AUC 5 IV
Phase 2 Cohort 1:
RP2D of magrolimab as determined in Safety Run-in 1
In combination with:
•
Pembrolizumab 200 mg IV
•
5-FU 1000 mg/m2/day continuous IV
•
Cisplatin 100 mg/m2 IV or carboplatin AUC 5 IV
•
Zimberelimab 360 mg IV
Phase 2 Cohort 2:
RP2D based upon the pre-expansion safety run-in for magrolimab + 
pembrolizumab if applicable)
In combination with pembrolizumab 200 mg IV
Safety Run-in 2 Starting Doses:
•
Magrolimab 1 mg/kg IV (priming dose)
•
Magrolimab 30 mg/kg IV
•
Magrolimab 60 mg/kg IV
In combination with docetaxel 75 mg/m2 IV
Phase 2 Cohort 3:
•
RP2D of magrolimab as determined in Safety Run-in 2.
Reference Therapy, 
Dose, and Mode of 
Administration:
Phase 2 Cohort 1:
•
Pembrolizumab 200 mg IV
•
5-FU 1000 mg/m2/day continuous IV
•
Cisplatin 100 mg/m2 IV or carboplatin AUC 5 IV
Optional Phase 2 Cohort 2:
•
Pembrolizumab 200 mg IV
Phase 2 Cohort 3:
•
Docetaxel 75 mg/m2 IV

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Criteria for 
Evaluation:
Safety:
Safety will be evaluated by data including the incidence of AEs for the 
duration of the study, assessment of clinical laboratory test findings, 
physical examinations, ECOG performance status, and vital signs 
measurements. Adverse events will be graded using NCI CTCAE, 
Version 5.0.
Efficacy:
Efficacy will be evaluated by PFS, ORR, DOR, OS, and PRO 
assessment (EORTC-QLQ-C30, EORTC QLQ-H&N35, and 
EQ-5D-5L) scores. For Phase 2 Cohort 1, the primary efficacy endpoint 
will be PFS as determined by investigator assessment. For Phase 2 
Cohorts 2 and 3, assessment of response will be measured by RECIST, 
Version 1.1, as determined by investigator assessment (primary efficacy 
endpoint).
Pharmacokinetics: For patients who receive magrolimab treatment, magrolimab serum drug 
concentrations will be assessed at predose at multiple time points until 
study discontinuation. Peripheral blood for immunogenicity assessments 
for ADAs against magrolimab will also be collected at predose at 
multiple time points during the study. Pharmacokinetic and ADA 
samples will also be collected and analyzed for patients who receive 
zimberelimab.
Statistical Methods:
Analysis Data Sets
For the safety run-in evaluations, the DLT-Evaluable Analysis Set will 
include all enrolled patients who meet either of the following criteria 
during the DLT assessment period:
•
The patient experiences a DLT at any time after initiation of the first 
infusion of magrolimab.
•
The patient does not experience a DLT and completes at least 
2 infusions of magrolimab and at least 1 dose of pembrolizumab, 
1 dose of 5-FU, and 1 dose of platinum for Safety Run-in 1; at least 1 
dose of docetaxel for Safety Run-in 2; and at least 1 dose of 
pembrolizumab for the pre-expansion safety run-in for magrolimab + 
pembrolizumab (if applicable).
For the safety run-in evaluations, the Modified Intent-to-Treat and 
Safety Analysis Set will include all patients who receive at least 1 dose 
of any study drug.

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For the Phase 2 Cohort 1 randomized comparisons, the Intent-to-Treat 
Analysis Set will include all randomized patients according to the 
treatment group to which the patients are assigned, unless otherwise 
specified. The Safety Analysis Set will include all randomized patients 
who receive at least 1 dose of any study drug, with treatment assignment 
designated according to the actual treatment received.
For Phase 2 Cohorts 2 and 3, the Modified Intent-to-Treat and Safety 
Analysis Sets will include all patients who receive at least 1 dose of any 
study drug.
The PK Analysis Set will include all patients who receive any amount 
of magrolimab or zimberelimab and have at least 1 measurable 
posttreatment serum concentration of magrolimab or zimberelimab.
The Immunogenicity Analysis Set will include all patients who receive 
any amount of magrolimab or zimberelimab and have at least 
1 evaluable anti-magrolimab or anti-zimberelimab antibody test result.
The Biomarker Analysis Set will include all patients who receive any 
study drug and have at least 1 evaluable biomarker measurement 
available.
Dose Determination Analysis
For the purposes of making the dose de-escalation decisions for the 
safety run-in evaluations, 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 1 dosing cycle (21 days).
Efficacy Analysis
For Phase 2 Cohort 1, PFS will be analyzed using Kaplan-Meier (KM) 
methods. Patients who do 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 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.
For Phase 2 Cohorts 2 and 3, the ORR along with the 95% CI based on 
the Clopper-Pearson method will be estimated. Patients who do not have 
sufficient baseline or on-study tumor assessments to characterize 
response will be counted as nonresponders.
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.

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Sample Size Calculation
For Phase 2 Cohort 1 Arm A versus Arm B, a total of 93 PFS events 
provides 75% power at a 1-sided alpha of 0.15 to detect an HR of 0.7 
(assuming median PFS of 7 months compared with a control group 
median PFS of 4.9 months) using an unstratified log-rank test. 
Assuming an accrual period of 15 months, a minimum follow-up time 
of 5 months, and a 10% annual drop-out rate, 66 patients per treatment 
group (Arm A versus Arm B) would be required to obtain 93 events. 
Once the Phase 2 Cohort 1 enrolls 20 patients in each Arm A and 
Arm B, Arm C will open. For Arm C versus Arm B, a total of 61 PFS 
events provides 64% power at a 1-sided alpha of 0.15 to detect an HR of 
0.7 (assuming a median PFS of 7 months compared with a control group 
median PFS of 4.9 months) using an unstratified log-rank test. 
Assuming an approximate accrual of 11 months, a minimum follow-up 
time of 5 months, and a 10% annual drop-out rate, 46 patients per 
treatment arm (Arm C versus concurrent Arm B) would be required to 
obtain 61 events. The control group assumption is based on 
pembrolizumab + platinum + 5-FU efficacy in a historical study 
(KEYNOTE-048). The power calculation was performed using 
EAST 6.5.
For Phase 2 Cohort 2, no formal sample size calculation has been 
performed (25 patients).
For Phase 2 Cohort 3, a sample size of 40 patients provides 83% power 
at a 1-sided alpha of 0.15 to detect an ORR of 18% compared with a 
null ORR of 7.9% using a chi-squared test. The null ORR is based on 
historical taxane efficacy data in the second-line setting. The 
power calculation was performed using nQuery 8.0.
This study will be conducted in accordance with the guidelines of Good Clinical Practice, 
including archiving of essential documents.

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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
5-FU
5-fluorouracil
ABO
any of the 4 blood groups A, B, AB, and O comprising the ABO system
ADA
antidrug antibody
AE
adverse event
ALT
alanine aminotransferase
AML
acute myeloid leukemia
ANC
absolute neutrophil count
AST
aspartate aminotransferase
AUC
area under the concentration versus time curve
AUCtau
area under the concentration versus time curve over the dosing interval
AxMP
auxiliary medicinal product
CD47
clusters of differentiation 47
CFR
Code of Federal Regulations
CI
confidence interval
Cmin
minimum observed concentration of study drug
CMV
cytomegalovirus
CNS
central nervous system
CPS
combined positive score
CR
complete response
CRC
colorectal cancer
CRF
case report form
CSCO
Chinese Society of Clinical Oncology
CT
computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
DAT
direct antiglobulin test
DLBCL
diffuse large B-cell lymphoma
DLT
dose-limiting toxicity
DNA
deoxyribonucleic acid
DOR
duration of response
DPD
dihydropyrimidine dehydrogenase
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EDC
electronic data capture
EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire - Core Questionnaire
EORTC QLQ-H&N35
European Organisation for Research and Treatment of Cancer Quality of Life - Head 
and Neck Module
EQ-5D-5L
5-level EuroQol 5 dimensions
EQ-VAS
EuroQol visual analogue scale
EU
European Union

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Fc
fragment crystallizable
FDA
Food and Drug Administration
GCP
Good Clinical Practice
G-CSF
granulocyte colony-stimulating factor
Gilead
Gilead Sciences
HIV
human immunodeficiency virus
HNSCC
head and neck squamous cell carcinoma
HPV
human papillomavirus
HR
hazard ratio
IB
investigator’s brochure
ICF
informed consent form
ICH
International Council for Harmonisation (of Technical Requirements for 
Pharmaceuticals for Human Use)
IEC
independent ethics committee
IgG4
immunoglobulin G4
IND
investigational new drug
IRB
institutional review board
irRECIST
immune-related Response Evaluation Criteria in Solid Tumors
IRR
infusion-related reaction
IRT
interactive response technology
ITT
intent to treat
IV
intravenous
Kd
dissociation constant
KM
Kaplan-Meier
mAb
monoclonal antibody
MDS
myelodysplastic syndrome
mHNSCC
metastatic head and neck squamous cell carcinoma
mITT
modified intent to treat
MRI
magnetic resonance imaging
MTD
maximum tolerated dose
NCI
National Cancer Institute
NHL
non-Hodgkin lymphoma
NSCLC
non-small-cell lung cancer
ORR
objective response rate
OS
overall survival
PBMC
peripheral blood mononuclear cell
PD
pharmacodynamic(s)
PD-1
programmed cell death protein 1
PD-L1
programmed cell death ligand 1
PFS
progression-free survival
PK
pharmacokinetic(s)
PR
partial response

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PRO
patient-reported outcome
PS
Patient Safety
PT
prothrombin time
PTT
partial thromboplastin time
RBC
red blood cell
RECIST
Response Evaluation Criteria in Solid Tumors
Rh
rhesus
RNA
ribonucleic acid
RO
receptor occupancy
RP2D
recommended Phase 2 dose
SAE
serious adverse event
SD
standard deviation
SIRPα
signal regulatory protein alpha
SOP
standard operating procedure
SRT
Safety Review Team
SSR
special situation report
SUSAR
suspected unexpected serious adverse reaction
T1DM
type 1 diabetes mellitus
ULN
upper limit of normal
US, USA
United States, United States of America
w/v
weight-to-volume ratio

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1.
INTRODUCTION
1.1.
Background
1.1.1.
Background on Head and Neck Squamous Cell Carcinoma
In the United States (US), head and neck cancers account for approximately 4% of all cancers. 
The annual incidence in the US is approximately 60,000 new cases, with approximately 
14,000 deaths. Several risk factors are associated with the incidence of head and neck cancers, 
including tobacco and alcohol consumption. In addition, human papillomavirus (HPV) infection 
is a causative agent for head and neck cancers. Squamous cell carcinomas account for over 90% 
of head and neck cancers arising in the oral cavity and larynx. Initial treatment of head and neck 
squamous cell carcinoma (HNSCC) is broken down by extent of disease (localized, 
locoregionally advanced, and metastatic). Patients with localized disease (stage I or II) have a 
5-year overall survival (OS) of 70% to 90% and are treated with definitive surgery and/or 
radiation therapy. In contrast, patients with metastatic disease have a poor prognosis, with a 
5-year OS of approximately 4% {Beckham 2019}. Systemic therapy with either chemotherapy 
and/or immune checkpoint inhibition is the standard-of-care for patients with recurrent or 
metastatic disease in the frontline setting.
Recently, immune checkpoint inhibitors, specifically anti–programmed cell death protein 1 
(PD-1) antibodies, have been approved for patients with metastatic HNSCC (mHNSCC). 
Notably, pembrolizumab was recently granted approval for the first-line treatment of metastatic 
or unresectable, recurrent HNSCC, as a monotherapy in patients whose tumors express 
programmed cell death ligand 1 (PD-L1) (combined positive score [CPS] ≥ 1) and in 
combination with 5-fluorouracil (5-FU) and platinum chemotherapy in patients regardless of 
PD-L1 status. This approval was based on results from a Phase 3, randomized, open-label, 
active-controlled, multicenter study comparing pembrolizumab monotherapy, 
pembrolizumab + 5-FU + platinum, and cetuximab + 5-FU + platinum (KEYNOTE-048). In the 
subgroup of patients with a PD-L1 CPS ≥ 1, treatment with pembrolizumab monotherapy 
resulted in an improved median OS compared with cetuximab + 5-FU + platinum (12.3 months 
versus 10.3 months, respectively; hazard ratio [HR]: 0.78; P = 0.0086) {Burtness 2019}. In the 
overall study population, regardless of PD-L1 status, treatment with pembrolizumab + 5-FU + 
platinum resulted in an improved median OS compared with cetuximab + 5-FU + platinum 
(13.0 months versus 10.7 months, respectively; HR: 0.77; P = 0.0034). Based on these results, 
pembrolizumab monotherapy for patients whose tumors express PD-L1 and pembrolizumab + 
5-FU + platinum for patients regardless of PD-L1 status have become standard-of-care options. 
However, novel agents that can improve OS in both groups are needed to enhance clinical 
benefit in this population that represents a high unmet medical need.
Patients who progress after initial immune checkpoint inhibitor therapy and/or chemotherapy are 
treated with taxanes, with a median progression-free survival (PFS) of 2.2 months and a median 
OS of 6.1 months {Siano 2017}. Patients with metastatic disease have a poor prognosis with 
limited tumor response. There is a significant unmet medical need in this patient population.

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1.2.
Magrolimab
1.2.1.
General Information
Cluster of differentiation 47 (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.
In mouse xenograft models, CD47-blocking monoclonal antibodies (mAbs) inhibit human 
xenograft tumor growth and metastasis by enabling the phagocytosis and elimination of cancer 
cells from various hematologic malignancies and solid tumors {Chao 2011a, Chao 2010a, Chao 
2011b, Edris 2012, Kim 2012, Majeti 2009, Willingham 2012}. Binding of CD47 expressed by 
cancer cells to its ligand, signal regulatory protein alpha (SIRPα), expressed on phagocytes leads 
to inhibition of tumor cell phagocytosis. Thus, blockade of the CD47 SIRPα-signaling pathway 
by an anti-CD47 antibody leads to phagocytosis and elimination of tumor cells. Selective 
targeting of tumor cells by an anti-CD47 antibody is due to the presence of prophagocytic signals 
expressed mainly on tumor cells and not on normal cell counterparts {Chao 2010b}. In addition, 
the anti-CD47 antibody can induce an anticancer T-cell response through cross-presentation of 
tumor antigens by macrophage and antigen-presenting cells after tumor cell phagocytosis {Liu 
2015b, Tseng 2013}.
Magrolimab is a humanized anti-CD47 mAb that blocks the interaction of CD47 with its receptor 
and enables phagocytosis of human cancer cells {Liu 2015a}. The activity of magrolimab is 
primarily dependent on blocking CD47 binding to SIRPα and not on the recruitment of fragment 
crystallizable (Fc)–dependent effector functions, although the presence of the immunoglobulin 
G4 (IgG4) 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 2015a}. 
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 and its potent nonclinical activity, magrolimab 
is being developed as a novel therapeutic candidate for solid tumors and hematologic 
malignancies.
The magrolimab clinical development program represents a novel strategy for the treatment of 
cancer and is the first therapeutic agent to target the CD47-SIRPα axis. Extensive nonclinical 
studies have demonstrated activity against both human solid tumors (breast, ovarian, pancreas, 
colon, leiomyosarcoma, bladder, prostate, and others) and hematologic malignancies 
(AML, acute lymphoblastic leukemia, non-Hodgkin lymphoma [NHL], myeloma, 
myelodysplastic syndrome [MDS], and others).

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According to the 2020 investigator’s brochure (IB), magrolimab is being investigated as an 
anticancer therapeutic in 6 ongoing clinical studies in the US and United Kingdom, as 
monotherapy or in combination with other therapeutics, for the treatment of NHL, colorectal 
cancer (CRC), AML, MDS, and ovarian cancer. A total of 568 patients have been treated as of 
the data cut-off dates in the 2020 IB.
While magrolimab has single-agent nonclinical and clinical activity, efficacy is best enhanced in 
combination with other anticancer agents. Nonclinical and clinical studies have shown that 
magrolimab combinations with cytotoxic agents can enhance prophagocytic signals on tumor 
cells through cytotoxicity, which can lead to synergistic phagocytosis of tumor cells and 
enhanced activity. As such, magrolimab is being evaluated clinically in several combinations 
with cytotoxic agents including chemotherapy.
For further information on magrolimab, refer to the current IB.
1.2.2.
Nonclinical Pharmacology and Toxicology
1.2.2.1.
Pharmacology
In vitro studies of magrolimab activity included protein and cell-based assays using cancer cell 
lines. Magrolimab showed high binding affinity to monomeric and bivalent human CD47 antigen 
with a dissociation constant (Kd) of 8 × 10−9 and 8 × 10−12 M, respectively. Magrolimab bound to 
cynomolgus monkey and human CD47 with high affinity of Kd = 10 and 8.0 pM, respectively, 
but did not bind to mouse CD47. No complement-dependent cytotoxicity activity of magrolimab 
was observed in AML cells, and no antibody-dependent cellular cytotoxicity activity of 
magrolimab was observed in Raji and HL60 cells. Magrolimab induced macrophage-mediated 
phagocytosis in rat myeloma and HL60 cells and did not induce apoptosis in AML cells. 
Expression of CD47 was observed on human peripheral blood cells, and magrolimab did not 
trigger phagocytosis by human macrophages of normal red blood cells (RBCs) or normal human 
bone marrow cells in vitro but was a potent inducer of phagocytosis of CD47-expressing AML 
cells in vitro. Moreover, the combination of magrolimab with cytotoxic agent azacitidine at a 
clinically relevant concentration enhanced phagocytosis of HL60 cells in vitro when compared 
with magrolimab or azacitidine alone. The combination of magrolimab and avelumab effectively 
enhanced phagocytosis of ovarian cancer cells by human macrophages compared with 
magrolimab or avelumab alone.
Nonclinical in vivo pharmacology studies using xenograft cancer models provide compelling 
evidence that magrolimab triggers phagocytosis and elimination of cancer cells from multiple 
human solid tumors and hematologic malignancies. Overall, magrolimab in combination with 
azacitidine, trastuzumab, rituximab, cetuximab, and panitumumab demonstrated additive effect 
on eliminating cancer cells in a variety of nonclinical cancer models, resulting in a long-term 
remission and increased survival of animals.
Receptor occupancy (RO) assays showed that optimal antitumor activity (phagocytosis) in 
HL60 cells and primary human AML cells could be achieved without full CD47 RO.

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The safety pharmacology evaluations as part of Good Laboratory Practice 8-week toxicology 
study demonstrated no magrolimab-related effects on central nervous system (CNS), 
cardiovascular, or respiratory function in cynomolgus monkey.
1.2.2.2.
Toxicology
In in vitro studies, magrolimab was not hemolytic, and there was no evidence of adverse 
elevations of proinflammatory cytokines.
In the pivotal 8-week repeat-dose toxicology study, magrolimab was administered to 
cynomolgus monkeys via a 1-hour intravenous (IV) infusion as a priming dose of 5 mg/kg in 
Week 1 (Day 1), followed by twice-weekly maintenance doses for 7 consecutive weeks at doses 
ranging from 5 to 100 mg/kg.
Treatment-related findings were limited to changes in hematology and clinical chemistry 
parameters and erythroid cell morphology.
Hematology changes included decreases in red cell mass associated with decreases in mean 
corpuscular volume and haptoglobin; increases in mean corpuscular hemoglobin concentration, 
reticulocytes, and red cell distribution width; red cell morphology changes including spherocytes 
(microcytes), eccentrocytes, atypical erythrocyte fragments consistent with erythrocyte injury, 
erythrocyte clumping, and large platelets; and changes associated with increased erythropoiesis 
consisting of anisocytosis, polychromatophilic macrocytes, and increased total bilirubin.
Changes in blood cell morphology were consistent with previous studies and considered to be 
associated with accelerated RBC destruction/clearance and increased erythropoiesis.
Additional clinical chemistry changes were observed at the highest dose only (100 mg/kg), 
which included a slight decrease in albumin, a slight increase in globulin, and a corresponding 
decrease in albumin:globulin ratio. There was partial to complete recovery for all 
treatment-related changes with the exception of increased spleen weights in males and females at 
50 and 100 mg/kg at recovery necropsy, which had no macroscopic or microscopic correlate. 
Based on these results, the highest nonseverely toxic dose for this study was considered to be 
100 mg/kg, the highest dose evaluated.
Reproductive and developmental toxicology studies have not been conducted by the sponsor, but 
all the available data (literature, data from knock-out mice, and limited clinical data) suggest no 
role for CD47 on embryo-fetal development.
1.2.3.
Clinical Background for Magrolimab
1.2.3.1.
Summary of Clinical Pharmacology
Clinical pharmacokinetic (PK) data have been collected in all ongoing studies of magrolimab 
conducted to date. Pharmacokinetic data have been analyzed in a Phase 1 study (SCI-CD47-001) 
in patients with solid tumors. In this study, patients were treated with weekly magrolimab doses 
ranging from 0.1 to 45 mg/kg, with increasing serum concentrations associated with increasing 
dose. Nonlinear PK consistent with target-mediated clearance was observed over this dose range. 

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However, at maintenance doses of 10 mg/kg and above, target-mediated clearance was saturated 
within the dosing regimen, and trough levels associated with magrolimab efficacy in nonclinical 
studies were achieved. Nine of 88 evaluable patients (10%) tested positive for antidrug antibody 
(ADA) against magrolimab at any time point including baseline; ADA positivity had no impact 
on PK or clinical safety in these patients.
In the Phase 1 AML study (SCI-CD47-002), similar to the solid tumor Phase 1 study, nonlinear 
PK consistent with target-mediated clearance was observed. Three of 20 evaluable patients 
(15%) tested positive for ADA against magrolimab at any time point including baseline; ADA 
positivity had no impact on PK. Antidrug antibody positivity in either study was not associated 
with increased adverse events (AEs).
Preliminary PK data of magrolimab from other ongoing studies (5F9003, 5F9004, and 5F9005) 
of magrolimab indicate similar PK properties across all tumor populations and in the presence of 
coadministered drugs. Across all studies, 46 of 430 patients (11%) tested positive for ADA 
against magrolimab at any time point including baseline. Antidrug antibody positivity was not 
associated with changes in PK or AE profile.
A preliminary population PK analysis of combined magrolimab PK data indicated that results for 
magrolimab population PK were typical of other nonlinear antibodies. No clinically significant 
covariates of PK variability were identified.
1.2.3.2.
Summary of Clinical Safety
Magrolimab is administered as an IV infusion and it is currently being studied in 6 clinical 
studies. Two completed single-agent Phase 1 studies include Study SCI-CD47-001 in patients 
with advanced solid tumors and lymphomas, and Study SCI-CD47-002 in patients with 
relapsed/refractory AML, along with 2 Phase 1b partnered studies in AML as well as urothelial 
carcinoma. Four combination studies include the following: Study 5F9003, a Phase 1b/2 study of 
magrolimab with rituximab in patients with relapsed/refractory NHL; Study 5F9004, a 
Phase 1b/2 study of magrolimab with cetuximab in patients with solid tumors and CRC; Study 
5F9005, a Phase 1b study of magrolimab with azacitidine in patients with AML and MDS; and 
Study 5F9006, a Phase 1b study of magrolimab with avelumab in patients with solid tumors and 
ovarian cancer. As of July 2020, over 500 patients have been treated with magrolimab. Overall, 
the safety profile has been acceptable with magrolimab as monotherapy or in combination, with 
no maximum tolerated dose (MTD) reached in any study with dosing up to 45 mg/kg. Two 
anticipated adverse reactions included on-target anemia and infusion-related reactions (IRRs), 
which are expected with mAbs. Importantly, on-target anemia due to CD47 blockade-mediated 
RBC clearance was mitigated with a priming/maintenance dose strategy. The average 
hemoglobin decline with the first (priming) dose was 0.4 g/dL, with many patients improving 
their hemoglobin on therapy with a decrease in RBC transfusion requirements.
Magrolimab has been evaluated as a monotherapy or in combination in multiple solid tumor 
types. In a Phase 1 study of magrolimab monotherapy (Study SCI-CD47-001), 88 patients with 
advanced solid tumors and lymphomas were treated with magrolimab doses up to 45 mg/kg. No 
MTD was reached. Among the 548 patients with solid tumors or hematologic malignancies who 
were treated with magrolimab, fatigue, anemia, and headache were the 3 most frequently 
reported all-grade AEs (43.0%, 40.8%, and 36.4% of patients, respectively).

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Anemia was the most common treatment-related AE, reported in 35.4% of patients. 
Approximately 13% of patients had Grade 1 or 2 anemia, and 22% of patients had severe 
anemia. Many of the AEs of severe anemia occurred in patients with AML and MDS who had 
severe anemia at baseline. Anemia was typically manifested as a decline in hemoglobin observed 
within the first 2 weeks of treatment. The initial decrease in hemoglobin after the first dose was 
0.5 to 2 g/dL on average. In patients with solid tumors, the decrease in hemoglobin was followed 
by a compensatory reticulocytosis, with many patients experiencing a gradual return to baseline 
despite continued dosing. The changes in hemoglobin and reticulocytes described with 
magrolimab treatment are fairly consistent across tumor types (Figure 1). Hyperbilirubinemia 
(predominately unconjugated) is indicative of extravascular hemolysis consistent with 
phagocytic removal of RBCs arising from the blockade of CD47 signaling. Administration of a 
low priming dose of magrolimab mitigated on-target anemia, an effect that is mostly observed 
after the first dose.
Figure 1.
Effect of Magrolimab on Anemia and Mitigation with a 
Priming/Maintenance Dosing Regimen
5F9 = magrolimab (GS-4721)
The red blood cell profile of a patient with solid tumors who was treated with magrolimab monotherapy is shown {Sikic 2019}.
Infusion-related reactions are also a commonly observed AE with magrolimab. In total, 
29% of patients reported at least 1 IRR. The most common signs/symptoms of IRR related to 
magrolimab included chills, pyrexia, back pain, headache, nausea, vomiting, dyspnea, anemia, 
and blood bilirubin increase. These IRRs were generally observed during the initial 2 doses of 
magrolimab. Current recommendations for premedication and IRR management are described in 
Section 5.9.2. Lastly, hemagglutination (RBC agglutination) as observed on the peripheral smear 
is a common treatment effect and was reported as a treatment-related AE in 11.8% of all patients.
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Transient hemagglutination is observed after the initial priming or first maintenance dose of 
drug; however, it is less common thereafter, and it has not been consistently correlated with any 
clinical sequelae.
In summary, as of July 2020, 568 patients (346 patients with solid tumors/lymphoma and 
222 patients with AML/MDS) have been treated with magrolimab as monotherapy or in 
combination. Based on this aggregate safety data, magrolimab has an acceptable safety profile 
both as monotherapy and in combination with other agents (rituximab, gemcitabine, oxaliplatin, 
cetuximab, avelumab, or azacitidine) across multiple advanced solid tumor and hematologic 
malignancies. Refer to the magrolimab IB for further details.
1.2.3.3.
Summary of Clinical Efficacy
Clinical efficacy with magrolimab has been observed in multiple solid tumor and hematologic 
malignancies. In the Phase 1 study of magrolimab monotherapy in advanced solid tumors 
(Study SCI-CD47-001), 2 of 16 patients (12.5%) with clear cell ovarian and fallopian tube 
carcinomas achieved a partial response (PR) per Response Evaluation Criteria in Solid Tumors 
(RECIST), Version 1.1, with time to progression of 5.2 and 9.2 months, respectively {Sikic 
2019}. In a Phase 1b/2 study of magrolimab in combination with cetuximab in patients with 
relapsed/refractory CRC (Study 5F9004), 2 objective responses out of 32 patients (6%) were 
observed in patients with relapsed/refractory metastatic KRAS wild-type CRC who were 
refractory to cetuximab with a disease control rate of 50% {Fisher 2020}. The OS in patients 
with KRAS wild-type and KRAS-mutant CRC treated with magrolimab and cetuximab was 
9.5 and 7.6 months, respectively. These data may compare favorably to historical data in patients 
with KRAS wild-type and KRAS-mutant CRC treated with standard of care, where a median OS 
of 8.0 and 6.5 months, respectively, was observed {Van Cutsem 2018}.
In hematologic malignancies, efficacy has been observed in NHL, MDS, and AML. In 
Study 5F9003, patients with relapsed/refractory NHL were treated with magrolimab in 
combination with rituximab. Among 97 patients with NHL who were evaluable for efficacy, 
which included patients with diffuse large B-cell lymphoma (DLBCL) and indolent lymphoma, 
the objective response rate (ORR) was 45%, with a complete response (CR) rate of 19% {Advani 
2019}. The ORR was 36% in 59 treated patients with DLBCL and 61% in 38 treated patients 
with indolent lymphoma. In Study 5F9005, patients with untreated AML who were ineligible for 
induction chemotherapy and patients with untreated higher-risk MDS were treated with 
magrolimab in combination with azacitidine. In 25 patients with AML, the ORR was 64% and 
the CR rate was 40% {Sallman 2020}. In 33 patients with MDS, the ORR was 91% and the CR 
rate was 42%. No median duration of response (DOR) was reached for either cohort, with 
median follow-up period of 9.4 months for AML and 5.8 months for MDS.
In summary, magrolimab has demonstrated combination efficacy across both solid tumors and 
hematologic malignancies. Refer to the magrolimab IB for further details.

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1.3.
Information About Pembrolizumab, Zimberelimab, 5-Fluorouracil, Platinum 
(Cisplatin or Carboplatin), and Docetaxel
1.3.1.
Description of Pembrolizumab
Pembrolizumab is a humanized IgG4 mAb with a high specificity of binding to the PD-1 
receptor, inhibiting its interaction with PD-L1 and programmed cell death ligand 2. 
Pembrolizumab is indicated for the treatment of patients across a number of indications, 
including HNSCC, as a monotherapy in patients whose tumors express PD-L1 (CPS ≥ 1) and in 
combination with 5-FU and platinum chemotherapy regardless of PD-L1 status.
Further information can be found in the current country-specific prescribing information.
1.3.2.
Description of Zimberelimab
Zimberelimab is a fully human IgG4 mAb targeting human PD-1. Zimberelimab, which is under 
development by Arcus Biosciences in partnership with Gilead Sciences, was generated by WuXi 
Biologics using the genetically engineered OmniRat platform, which was developed by Open 
Monoclonal Technology Company. Zimberelimab comprises 2 heavy chains of the IgG4 
subclass and 2 light chains of the lambda subclass. The 4 chains are stabilized by multiple 
disulfide bonds, with a single glycosylation site (Asn300) located on the heavy chain. The 
molecular weight of zimberelimab is 144 kDa (deglycosylated mass), and its isoelectric point is 
7.0.
1.3.3.
Description of 5-Fluorouracil
5-Fluorouracil is a pyrimidine analog used as a chemotherapy drug and is indicated for the 
treatment of multiple solid tumors, including colorectal, breast, pancreatic, and gastric 
adenocarcinoma. It is also used in combination with platinum-based chemotherapy for the 
treatment of multiple solid tumors, including HNSCC.
Further information can be found in the current country-specific prescribing information.
1.3.4.
Description of Cisplatin
Cisplatin is a platinum-based chemotherapy drug indicated for the treatment of multiple solid 
tumors including testicular, ovarian, and bladder cancer. It is also widely used for the treatment 
of other solid tumors, including HNSCC, lung, and cervical cancer.
Further information can be found in the current country-specific prescribing information.
1.3.5.
Description of Carboplatin
Carboplatin is a platinum-based chemotherapy drug indicated for the treatment of ovarian 
cancer. It is also widely used for the treatment of multiple solid tumors, including HNSCC, lung, 
and bladder cancer.
Further information can be found in the current country-specific prescribing information.

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1.3.6.
Description of Docetaxel
Docetaxel is an anticancer chemotherapy drug classified as an antimicrotubule inhibitor and 
taxane. Docetaxel is indicated for multiple solid tumors, including HNSCC.
Further information can be found in the current country-specific prescribing information.
1.3.7.
Clinical Data for Pembrolizumab
Pembrolizumab is indicated for the treatment of multiple solid tumors, including as a 
monotherapy for the first-line treatment of patients with metastatic or unresectable, recurrent 
HNSCC whose tumors express PD-L1 (CPS ≥ 1) {KEYTRUDA 2020a, KEYTRUDA 2020b}.
The approval of pembrolizumab monotherapy in HNSCC was based on results from the 
KEYNOTE-048 study, in which a total of 882 patients were enrolled. Treatment with 
pembrolizumab monotherapy resulted in an improved median OS compared with cetuximab + 
5-FU + platinum in the subgroup of patients with a PD-L1 CPS ≥ 1 (12.3 months versus 
10.3 months, respectively; HR: 0.78; P = 0.0086) and in the subgroup of patients with a PD-L1 
CPS ≥ 20 (14.9 months versus 10.7 months; HR: 0.61; P = 0.0007) {Burtness 2019}. The 
median PFS in the pembrolizumab monotherapy group compared with the cetuximab + 5-FU + 
platinum group was 3.2 months versus 5.0 months, respectively, in the subgroup of patients with 
a PD-L1 CPS ≥ 1 and 3.4 months versus 5.0 months, respectively, in the subgroup of patients 
with a PD-L1 CPS ≥ 20. The ORR in the pembrolizumab monotherapy group compared with the 
cetuximab + 5-FU + platinum group was 19% versus 35%, respectively, in the subgroup of 
patients with a PD-L1 CPS ≥ 1 and 23% versus 36%, respectively, in the subgroup of patients 
with a PD-L1 CPS ≥ 20.
The most common AEs (≥ 10%) included fatigue, constipation, rash, nausea, diarrhea, vomiting, 
dyspnea, cough, hypothyroidism, decreased appetite, weight loss, pyrexia, pneumonia, headache, 
myalgia, and pruritus {KEYTRUDA 2020a, KEYTRUDA 2020b}. Pembrolizumab can cause 
severe or life-threatening IRRs including hypersensitivity and anaphylaxis, which have been 
reported in 6 of 2799 patients (0.2%) receiving pembrolizumab. Pembrolizumab can also cause 
immune-mediated reactions, some of which may be severe or fatal. Immune-mediated reactions 
include pneumonitis, colitis, hepatitis, adrenal insufficiency, hypophysitis, thyroid disorders, 
type 1 diabetes mellitus, and skin reactions such as Stevens-Johnson syndrome and toxic 
epidermal necrolysis. Other immune-mediated reactions have also been observed with 
pembrolizumab and other PD-1/PD-L1 blocking antibodies, and they may also occur after 
discontinuation of treatment. Grade 3 or 4 laboratory abnormalities that worsened from baseline 
in ≥ 20% of patients included lymphopenia.
In summary, pembrolizumab monotherapy is an effective treatment option for the first-line 
treatment of patients with metastatic or unresectable, recurrent HNSCC whose tumors express 
PD-L1 (CPS ≥ 1).
1.3.8.
Clinical Data for Zimberelimab
To date, 260 patients have been treated with zimberelimab in ongoing clinical studies sponsored 
by Arcus Biosciences.

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At 360 mg every 3 weeks, mean area under the concentration-time curve to the end of the dosing 
period and minimum concentration were 21,000 ± 3780 μg•h/mL and 17.9 ± 6.27 μg/mL, 
respectively. Overall, the observed exposures were well below those reached in a 4-week toxicity 
study in cynomolgus monkeys.
Gloria Biosciences reported at the Chinese Society of Clinical Oncology (CSCO) in August 2019 
(abstract available on request) that zimberelimab monotherapy has been evaluated in China in a 
Phase 1a/1b study (NCT03713905) in 220 patients with advanced relapsed/refractory solid 
tumors or lymphoma. These patients displayed multiple tumor types, including 35 patients with 
relapsed non-small-cell lung cancer (NSCLC). In these patients, the ORR was 25.7%, with a 
median duration of treatment of less than 4 months. Over the course of this study, no 
dose-limiting toxicity (DLT) has been reported and enrollment continues.
Encouraging data from 2 Phase 2 trials of zimberelimab monotherapy were presented at the 
American Society of Clinical Oncology Annual Meeting 2020. In a study of 44 patients with 
recurrent or metastatic PD-L1 positive (CPS > 1) cervical cancer (NCT03972722), zimberelimab 
was reported to have a manageable safety profile with an ORR of 28% {Wu 2020}. Additionally, 
in a study of 85 patients with relapsed or refractory classical Hodgkin’s lymphoma 
(NCT03655483), zimberelimab demonstrated a manageable safety profile, and 91.8% of patients 
had a confirmed objective response, as assessed by an independent review committee, including 
30 patients (35.3%) with CR and 48 patients (56.5%) with PR. Median DOR and PFS were not 
yet reached {Lin 2021}.
The most common AEs (≥ 10%) include fatigue, anemia, nausea, constipation, diarrhea, 
decreased appetite, pyrexia, neutrophil count decreased, dyspnea, alanine aminotransferase 
increased, aspartate aminotransferase increased, and headache (IB, V6).
For further information on zimberelimab, refer to the current IB.
1.3.9.
Clinical Data for Pembrolizumab in Combination With 5-Fluorouracil and 
Platinum (Cisplatin or Carboplatin) Chemotherapy
Pembrolizumab in combination with 5-FU and platinum chemotherapy is indicated for the 
first-line treatment of patients with metastatic or unresectable, recurrent HNSCC regardless of 
PD-L1 status {KEYTRUDA 2020a, KEYTRUDA 2020b}.
Results from the KEYNOTE-048 study also led to the approval of the combination therapy in 
HNSCC. In the overall study population, regardless of PD-L1 status, treatment with 
pembrolizumab + 5-FU + platinum resulted in an improved median OS compared with 
cetuximab + 5-FU + platinum (13.0 months versus 10.7 months; HR: 0.77; P = 0.0034) 
{Burtness 2019}. The median PFS in the pembrolizumab + 5-FU + platinum group compared 
with the cetuximab + 5-FU + platinum group was 4.9 months versus 5.1 months, respectively. In 
both the pembrolizumab + 5-FU + platinum and cetuximab + 5-FU + platinum groups, the ORR 
was 36%.
The most common AEs (≥ 20%) included fatigue, mucosal inflammation, constipation, nausea, 
diarrhea, vomiting, stomatitis, cough, and decreased appetite {KEYTRUDA 2020a, 
KEYTRUDA 2020b}. Grade 3 or 4 laboratory abnormalities that worsened from baseline in 
≥ 20% of patients included lymphopenia, anemia, neutropenia, and hyponatremia.

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In summary, pembrolizumab in combination with 5-FU and platinum chemotherapy is an 
effective treatment option for the first-line treatment of patients with metastatic or unresectable, 
recurrent HNSCC regardless of PD-L1 status.
1.3.10.
Clinical Data for Docetaxel
Docetaxel is approved for use in multiple solid tumors, including HNSCC {Taxotere® 1995, 
Taxotere® 1996}. Docetaxel is also widely used as standard of care in multiple solid tumors, 
including for the treatment of patients with HNSCC who fail first-line chemotherapy and/or 
immune checkpoint inhibitor therapy.
The most common AEs across all docetaxel indications are infections, neutropenia, anemia, 
febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, 
constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, 
mucositis, alopecia, skin reactions, and myalgia. Docetaxel is contraindicated in patients with 
neutrophil counts < 1500 cells/mm3 and in patients with hypersensitivity to docetaxel or 
polysorbate 80. Docetaxel carries a black box warning for toxic deaths, hepatotoxicity, 
neutropenia, hypersensitivity reactions, and fluid retention. In addition, cutaneous reactions, 
severe skin toxicity, neurologic reactions (including paresthesia, dysesthesia, and pain), asthenia, 
and potential fetal harm have been observed with docetaxel.
In general, the efficacy observed with docetaxel monotherapy in patients who fail standard 
chemotherapy, immune checkpoint inhibitor therapy, or the combination results in an ORR of 
approximately 7.9% in HNSCC {Cohen 2019, Ferris 2016}. The median PFS is approximately 
7.4 weeks {Specenier 2011}.
1.3.11.
Information on Study Auxiliary Medicinal Products/Noninvestigational 
Medicinal Products
Acetaminophen (also known as paracetamol), diphenhydramine, and dexamethasone are 
considered auxiliary medicinal products (AxMPs) for this clinical study (Appendix 13). 
Acetaminophen is approved for pain relief and fever reduction. Diphenhydramine is an 
antihistamine and is approved for amelioration of allergic reactions. Dexamethasone is an 
anti-inflammatory medication and is used for the amelioration of allergic reactions. The use of 
these medications in this study is described in Section 5.9.2. Additional details on acetaminophen 
and diphenhydramine can be found in the prescribing information.
1.4.
Rationale for This Study
Despite recent therapeutic improvements in the first-line mHNSCC setting, novel therapies and 
combinations are needed to extend survival benefit in this high unmet need population. Recently, 
the US Food and Drug Administration (FDA) approved pembrolizumab as a monotherapy in 
patients whose tumors express PD-L1 (CPS ≥ 1) and pembrolizumab in combination with 5-FU 
+ platinum in patients regardless of PD-L1 tumor expression. These approvals were based on an 
approximately 2- to 3-month survival benefit in both settings, demonstrating the need for 
therapeutic combinations to improve patient benefit.

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Magrolimab is a macrophage immune checkpoint inhibitor blocking CD47 that can activate both 
the innate and adaptive immune system through its unique mechanism of action. Several lines of 
evidence support the combination of magrolimab with T-cell checkpoint inhibitors with or 
without chemotherapy in patients with HNSCC. In syngeneic mouse models, CD47 blockade led 
to significant reduction in tumor growth {Wu 2018}. In a Phase 1 study of magrolimab 
monotherapy that included 4 patients with HNSCC (Study SCI-CD47-001), magrolimab was 
well tolerated and prolonged disease stabilization in several patients {Sikic 2019}. Strong 
scientific rationale and nonclinical data also support the combination of magrolimab with T-cell 
checkpoint inhibitors. Macrophage phagocytosis of tumor cells by CD47 blockade leads to 
cross-presentation of tumor antigens by macrophages to T cells, thus engaging a T-cell antitumor 
response {Tseng 2013}. Multiple nonclinical studies demonstrate that the addition of CD47 
blockade to anti–PD-1/L1 checkpoint blockade enhances antitumor efficacy through stimulation 
of both innate and adaptive immune responses {Gordon 2017, Sockolosky 2016}. Thus, the 
combination of CD47 blockade and PD-1/PD-L1 T-cell checkpoint blockade is anticipated to 
enhance antitumor efficacy by combining both innate and adaptive immune responses. Indeed, 
multiple nonclinical studies have demonstrated enhancement of antitumor efficacy when an 
anti-CD47 antibody is combined with anti–PD-1/PD-L1 blockade in multiple solid tumor types 
{Lian 2019, Liu 2018, Wang 2020}. Magrolimab can also enhance the antitumor efficacy of 
chemotherapy by enhancing phagocytosis via upregulation of prophagocytic signals on tumor 
cells. Magrolimab in combination with chemotherapy led to substantial reduction of tumor 
growth in solid tumor xenograft models {Kiss 2020}. Furthermore, clinical studies evaluating 
magrolimab in combination with combination chemotherapy are ongoing. In an ongoing 
Phase 1b/2 study of magrolimab in combination with rituximab, gemcitabine, and oxaliplatin 
(Study 5F9003), the combination therapy has been well tolerated, with no MTD reached and 
patients being evaluated for preliminary efficacy in an expansion cohort.
To date, magrolimab has been evaluated in patients in combination with anti–PD-L1 inhibitors. 
Study 5F9006 evaluated magrolimab in combination with avelumab in relapsed/refractory 
ovarian cancer. An additional ongoing study (WO39613) is evaluating magrolimab in 
combination with atezolizumab in second-line bladder cancer. In both studies, magrolimab has 
been well tolerated with either avelumab or atezolizumab, with no MTD reached. In addition, no 
substantial enhancement of immune-activating AEs observed with T-cell checkpoint inhibitors 
was observed when magrolimab was added in combination (data on file).
Emerging clinical data with CD47 blockade in combination with pembrolizumab suggest 
potential activity in HNSCC. A combination of ALX148 (a CD47-blocking SIRPα-Fc fusion 
protein) with pembrolizumab in 10 patients with checkpoint inhibitor–naive relapsed/refractory 
HNSCC led to an ORR of 40% {Chow 2020}. In addition, ALX148 is also being evaluated in 
combination with pembrolizumab + 5-FU + platinum. Three of 4 patients (75%) treated with this 
combination achieved an objective response, with 1 patient achieving a CR {Lee 2020}. 
Furthermore, this CD47-blocking agent in combination with either pembrolizumab or 
pembrolizumab + chemotherapy was well tolerated, with no MTD reached. No significant safety 
signals were observed beyond what was expected from pembrolizumab or pembrolizumab in 
combination with chemotherapy, suggesting that CD47-targeting agents can be safely combined 
with these combinations. While patient numbers are limited, these data suggest potential 
meaningful combination activity of CD47 blockade and pembrolizumab compared with 
historical response rates of pembrolizumab monotherapy or pembrolizumab in combination with 
chemotherapy in this setting.

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In nonclinical models, zimberelimab was observed to be similar to the approved anti–PD-1 
checkpoint inhibitor, pembrolizumab, with comparable interferon-gamma production in an 
allogenic model, distinct but overlapping PD-1 binding epitopes, and a higher kinetic affinity to 
PD-1. Additionally, based on clinical data in 39 patients, zimberelimab has pharmacodynamic 
([PD]; increased proliferating Ki-67 positive T cells in blood), and PK properties comparable to 
approved PD-1 agents, pembrolizumab and nivolumab. Thus, zimberelimab has been included in 
Cohort 1 Arm C to investigate the combination potential with magrolimab, platinum, and 5-FU. 
For further information on zimberelimab, refer to the current IB. 
In summary, the combined nonclinical rationale of magrolimab in combination with checkpoint 
inhibitors and/or chemotherapy, initial tolerability of magrolimab in patients with HNSCC, and 
emerging clinical efficacy of CD47 blockade with immune checkpoint inhibitors support the 
rationale for the proposed combinations in this study.
1.5.
Rationale for Dose Selection
1.5.1.
Magrolimab
The rationale for the magrolimab dose proposed in this study originates from safety, efficacy, 
and PK/PD data, and modeling and simulation analyses based on data obtained from all ongoing 
and completed clinical studies with magrolimab in patients with solid tumors, NHL, and 
AML/MDS.
In the first-in-human study of magrolimab (Study SCI-CD47-001) in patients with solid tumors 
and lymphomas, after an initial priming dose of 1 mg/kg on the first day, magrolimab was tested 
as a monotherapy at weekly doses of up to 45 mg/kg. The use of an initial 1-mg/kg priming dose 
was integrated into the dosing regimen to mitigate the on-target anemia induced by CD47 
blockade. An initial priming dose leads to elimination of aged RBCs that are sensitive to CD47 
blockade and triggers reticulocytosis of young RBCs that are not affected by CD47 blockade 
{Chen 2018}. Utilizing a priming dose leads to an initial, transient, and mild anemia that 
generally normalizes back to baseline over several weeks, even in the presence of repeated 
therapeutic doses of magrolimab {Advani 2018, Liu 2015a, Sikic 2019}. The maximum weekly 
dose of 45 mg/kg has an acceptable safety profile, and no MTD was identified in this study. In 
Studies 5F9004 (patients with solid tumors and CRC) and 5F9006 (patients with solid tumors 
and ovarian cancer), magrolimab, in combination with cetuximab and avelumab, respectively, 
was found to have an acceptable safety profile at doses up to 45 mg/kg every week followed by 
every other week.
In solid tumors where the combination therapy (chemotherapy or pembrolizumab/zimberelimab) 
is given according to 3-week cycles, dosing of magrolimab every 3 weeks optimizes patient and 
caregiver convenience. Magrolimab 60 mg/kg every 3 weeks dose is predicted to provide a 
similar trough concentration and RO as the 30 mg/kg every 2 weeks dose, the dose being used in 
Phase 3 studies in AML and MDS. Updated PK modeling from the 5F9005 study showed that 
the magrolimab dose of 45 mg/kg every 3 weeks was suboptimal compared with 30 mg/kg every 
2 weeks and 60 mg/kg every 3 weeks in maintaining similar trough concentration. Maintaining 
adequate trough concentration may be necessary for optimal efficacy considering that some 
patients may experience dose delays due to toxicity. Furthermore, the PK-PD modeling also 
indicates that at these extended interval dosing regimens, the RO will be maintained at maximal 

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levels (> 90%) in peripheral blood and tumor tissues. The proposed dosing regimen of 
magrolimab in this study is expected to have an acceptable safety profile based on the entirety of 
safety data in multiple oncology populations, both as a monotherapy and in combination with 
other tumor targeted antibodies and chemotherapeutics.
1.5.2.
Zimberelimab
The dose and schedule of zimberelimab (360 mg every 3 weeks) to be evaluated in this study 
was determined based on preliminary PK, PD, and safety findings from the ongoing Phase 1 
study of zimberelimab in patients with advanced solid tumors (AB122CSP0001). Refer to the 
Zimberelimab IB, Edition 6 for nonclinical results and preliminary clinical PK, PD, and safety 
results from Study AB122CSP0001.
In vitro studies with zimberelimab have indicated that serum concentrations in excess of 
approximately 1.5 μg/mL (corresponding to ~10 nM) would provide a maximal blockade of 
PD-1 (or RO) on blood T cells. The preliminary PK data available for zimberelimab from Study 
AB122CSP0001 indicate that, in the zimberelimab 240 mg every 2 weeks cohort (n = 6), a 
minimum concentration (Cmin) of 15.3 ± 5.44 μg/mL (corresponding to approximately 
105.9 ± 37.7 nM) was achieved. The mean AUC from 0 to 14 days (AUCtau) for Cycle 1 Day 1 
in this cohort (10,200 ± 2500 μg•h/mL) was comparable to the value of 8790 μg•h/mL reported 
for the approved anti–PD-1 agent nivolumab at the dose of 3 mg/kg every 2 weeks {Center for 
Drug Evaluation and Research (CDER) 2014}. In the zimberelimab 360 mg every 3 weeks 
cohort (n = 6), higher Cmin and AUCtau for Cycle 1 Day 1 were observed at 17.9 μg/mL and 
21,000 μg•h/mL, respectively.
Dosing regimens of approved anti–PD-1 antibodies are associated with RO on peripheral blood 
T cells in excess of 65% {Topalian 2012}. While different assay formats have been used by 
different groups to quantify RO, at least 1 of the assays employed in Study AB122CSP0001 is 
similar to the one employed to describe the effects of nivolumab {Topalian 2012}. Consistent 
with the potency of zimberelimab in in vitro assays, a preliminary analysis of clinical samples 
from Study AB122CSP0001 confirmed that, in the 240-mg every 2 weeks cohort, ≥ 65% RO 
(defined using 2 different assays) was achieved at all measured time points, including in Cycle 1 
Day 15 predose samples, when serum concentrations of zimberelimab were lowest, just prior to 
administration of the Cycle 1 Day 15 dose. The 360 mg every 3 weeks dosing regimen was 
evaluated in Study AB122CSP0001 (n = 6). Using 2 different assay methods, RO of ≥ 65% was 
achieved at the Cmin time points evaluated.
The available PK and PD data support the maximal exposure and binding of zimberelimab at 
360 mg every 3 weeks, which would allow for maximal clinical activity.
1.6.
Risk/Benefit Assessment for the Study
First-line locally advanced or mHNSCC has a poor prognosis despite current therapies, with a 
median OS of approximately 10 to 12 months. Pembrolizumab is indicated for patients whose 
tumors express PD-L1 (CPS ≥ 1), whereas pembrolizumab in combination with 5-FU and 
platinum is indicated for patients regardless of PD-L1 status. The approvals of pembrolizumab as 
a monotherapy and in combination with chemotherapy were based on a median OS benefit of 
approximately 2 to 3 months over standard of care, underlying the great unmet needs of this 

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population. Therapies are needed that can enhance the activity of pembrolizumab as a 
monotherapy and in combination with chemotherapy in a manner that is well tolerated {Burtness 
2019}.
Strong scientific and nonclinical data support the rationale for combining magrolimab with 
pembrolizumab or with pembrolizumab, 5-FU, and platinum. Multiple nonclinical in vivo 
models demonstrate improved efficacy with the addition of CD47 blockade to T-cell checkpoint 
inhibitors and/or chemotherapy. Furthermore, initial clinical data demonstrate an encouraging 
efficacy signal when CD47 blockade is combined with pembrolizumab in second-line checkpoint 
inhibitor–naive HNSCC {Chow 2020}. Specifically, in 10 patients, a 40% ORR was observed 
with pembrolizumab in combination with ALX148, a SIRPα-Fc fusion protein that blocks CD47. 
In addition, 3 of 4 patients (75%) treated with ALX148 in combination with pembrolizumab, 
5-FU, and platinum achieved an objective response {Lee 2020}. While patient numbers are 
limited, these initial data suggest a potential efficacy benefit of the combination compared with 
pembrolizumab alone or pembrolizumab in combination with chemotherapy. In addition, 
magrolimab has shown combination efficacy when added with chemotherapeutic regimens, 
including platinum-containing chemotherapy. In an ongoing Phase 1b/2 study (5F9003), 
magrolimab in combination with rituximab, gemcitabine, and oxaliplatin was shown to be well 
tolerated and induced several objective responses, including complete remissions, in the 
Phase 1b dose-escalation phase. This study is now enrolling in the expansion phase. Thus, 
multiple lines of evidence support the therapeutic potential of magrolimab in combination with 
pembrolizumab, with and without 5-FU and platinum.
There are no significant, anticipated overlapping toxicities between magrolimab and 
pembrolizumab, with the exception of IRRs. Similarly, there are no significant, anticipated 
overlapping toxicities between magrolimab and zimberelimab (except IRRs). Infusion-related 
reactions are mitigated with several measures in this study, including close patient monitoring, 
premedications, and guidance regarding the treatment of IRR should it occur. Experience from 
other anti–PD-1 agents such as pembrolizumab can provide an understanding of potential risks. 
Immune-activating AEs have not been associated with magrolimab. In addition, 2 studies have 
evaluated magrolimab in combination with anti–PD-L1 antibodies (avelumab in ovarian cancer 
[Study 5F9006] and atezolizumab in bladder cancer and AML [Study WO39613]). The 
combinations of magrolimab with anti–PD-L1 antibodies (avelumab and atezolizumab) were 
generally well tolerated with no MTD reached in any study. Thus, the safety profile of 
magrolimab in combination with pembrolizumab is expected to be acceptable. The safety profile 
of magrolimab in combination with platinum + 5-FU or docetaxel is also expected to be 
acceptable with minimum overlapping toxicities. Anemia, neutropenia, thrombocytopenia, and 
infections have been reported in patients treated with magrolimab and are potential overlapping 
toxicities with platinum, 5-FU, and docetaxel in this study. However, these toxicities are 
mitigated with several measures, including a priming/maintenance dose strategy for magrolimab 
to mitigate on-target anemia and transfusion as needed, frequent complete blood counts to 
monitor neutrophil and platelet counts, and enrollment of patients with a hemoglobin level of 
at least 9 g/dL. Guidance for magrolimab dosing during episodes of neutropenia or infection is 
provided in Section 7.8.1.6 and Section 7.8.1.7, respectively. Magrolimab is currently being 
evaluated with other platinum-containing chemotherapeutic regimens (including a combination 
with rituximab, gemcitabine, and oxaliplatin in DLBCL). Magrolimab in combination with 
rituximab, gemcitabine, and oxaliplatin has been well tolerated, with no MTD reached. Overall, 

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magrolimab in combination with pembrolizumab with or without 5-FU and platinum 
chemotherapy, magrolimab in combination with zimberelimab with 5-FU and platinum 
chemotherapy, or magrolimab in combination with docetaxel is expected to have an acceptable 
safety profile.
During a pandemic, additional potential risks to patients may include adequate study drug 
availability, interruptions to the study visit schedule, and adherence to protocol-specified safety 
monitoring or laboratory assessments. Refer to Appendix 3 for further details on the risks and 
risk mitigation strategy.
In summary, based on strong scientific rationale, nonclinical, and emerging clinical data, lack of 
potential toxicities, and the risk mitigation measures being implemented for the pandemic, the 
evaluation of magrolimab in combination with pembrolizumab + platinum + 5-FU, magrolimab 
in combination with pembrolizumab, and magrolimab in combination with docetaxel in patients 
with HNSCC is anticipated to have an acceptable risk-benefit ratio for the patients enrolled in 
this study.
1.7.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.

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2.
OBJECTIVES AND ENDPOINTS
The study objectives and endpoints are presented in Table 1. Analyses of the study endpoints are 
described in Section 8.
Table 1.
Study Objectives and Endpoints
Primary Objectives
Primary Endpoints
Safety Run-in:
•
To evaluate the safety, tolerability, and RP2D of 
magrolimab in combination with the following:

Pembrolizumab + platinum + 5-FU 

Docetaxel
Phase 2 Cohorts:
•
To evaluate the PFS with magrolimab in 
combination with pembrolizumab + platinum + 5-
FU versus pembrolizumab + platinum + 5-FU as 
determined by investigator assessment 
(Phase 2 Cohort 1)
•
To evaluate the efficacy of magrolimab in 
combination with pembrolizumab, if this optional 
cohort is opened, and magrolimab in combination 
with docetaxel as determined by the 
investigator-assessed ORR (Phase 2 Cohorts 2 and 3)
Safety Run-in:
•
Incidence of AEs and laboratory abnormalities 
defined as DLTs according to the NCI CTCAE, 
Version 5.0 (Appendix 4)
Phase 2 Cohorts:
•
PFS, defined as the time from the date of 
randomization until the earliest date of 
documented disease progression, as determined by 
investigator assessment, or death from any cause, 
whichever occurs first (Phase 2 Cohort 1, Arm A 
versus Arm B)
•
ORR, defined as the proportion of patients who 
achieve a CR or PR as measured by RECIST, 
Version 1.1, as determined by investigator 
assessment (Phase 2 Cohorts 2 and 3)
Secondary Objectives
Secondary Endpoints
Safety Run-in:
•
To evaluate the PK and immunogenicity of 
magrolimab in combination with anticancer 
therapies
Phase 2 Cohorts:
•
To evaluate PFS for magrolimab + zimberelimab 
+ platinum + 5-FU versus pembrolizumab + 
platinum + 5-FU as determined by investigator 
assessment (Phase 2 Cohort 1)
•
To evaluate ORR as determined by investigator 
assessment (Phase 2 Cohort 1)
•
To evaluate PFS by investigator assessment (Phase 
2 Cohorts 2 and 3)
•
To evaluate additional measures of efficacy, 
including DOR and OS
•
To evaluate the PK and immunogenicity of 
magrolimab in combination with anticancer 
therapies
•
To evaluate PROs/quality-of-life measures 
Safety Run-in:
•
Magrolimab concentration versus time and 
ADAs to magrolimab
Phase 2 Cohorts:
•
PFS, as determined by investigator assessment or 
death from any cause, whichever occurs first 
(Phase 2 Cohort 1, Arm C versus concurrent 
Arm B)
•
ORR, as determined by investigator assessment 
(Phase 2 Cohort 1)
•
PFS from date of dose initiation (Phase 2 Cohort 2 
and Phase 2 Cohort 3) until 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
•
DOR, defined as time from first documentation of 
CR or PR to the earliest date of documented 
disease progression or death from any cause, 
whichever occurs first
•
OS, defined as time from date of randomization 
(Phase 2 Cohort 1) or date of dose initiation 
(Phase 2 Cohort 2 and Phase 2 Cohort 3) to death 
from any cause

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•
Magrolimab concentration versus time and ADAs 
to magrolimab
•
PRO assessment (EORTC QLQ-C30, 
EORTC QLQ-H&N35, and EQ-5D-5L) scores 
5-FU = 5-fluorouracil; ADA = antidrug antibody; AE = adverse event; CR = complete response; CTCAE = Common 
Terminology Criteria for Adverse Events; DLT = dose-limiting toxicity; DOR = duration of response; EORTC 
QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire; 
EORTC QLQ-H&N35 = European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module; 
EQ-5D-5L = 5-level EuroQol 5 dimensions questionnaire; NCI = National Cancer Institute; ORR = objective response rate; 
OS = overall survival; PD = pharmacodynamic(s); PFS = progression-free survival; PK = pharmacokinetic(s); PR = partial 
response; PRO = patient-reported outcome; RECIST = Response Evaluation Criteria in Solid Tumors; RP2D = recommended 
Phase 2 dose
CCI

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3.
STUDY DESIGN
3.1.
Study Design
This is a Phase 2, open-label, multicenter study evaluating magrolimab in combination with 
pembrolizumab + platinum + 5-FU chemotherapy; magrolimab in combination with 
pembrolizumab; magrolimab in combination with zimberelimab + platinum + 5-FU 
chemotherapy in patients with untreated metastatic or unresectable, locally recurrent HNSCC; 
and magrolimab in combination with docetaxel in patients with locally advanced/mHNSCC who 
were previously treated with at least 1 and no more than 2 lines of prior systemic therapy.
This study will consist of the following 2 safety run-in evaluations:
•
Safety Run-in 1: magrolimab + pembrolizumab + platinum + 5-FU in patients with 
untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status
•
Safety Run-in 2: magrolimab + docetaxel in patients with locally advanced/mHNSCC 
regardless of PD-L1 status who were previously treated with at least 1 and no more than 
2 lines of prior systemic therapy
Additionally, a pre-expansion safety run-in evaluation of magrolimab + pembrolizumab in 
patients with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 
CPS ≥ 1 may be conducted at the sponsor’s discretion prior to the initiation of the optional 
Phase 2 Cohort 2 evaluating a single arm of magrolimab + pembrolizumab.
Once the Safety Review Team (SRT) reviews the safety for the patients in each run-in and the 
sponsor determines the recommended Phase 2 dose (RP2D) for that cohort, Phase 2 Cohorts 1 
and 3 will be conducted, as described in Section 3.1.2.
Patient participation will include screening, randomization (Phase 2 Cohort 1 only), treatment, 
and follow-up. Screening will last up to 30 days before first dose of study treatment, during 
which time the patient’s eligibility and baseline characteristics will be determined. Patients will 
receive study treatment per the dose schedule in Appendix Table 1.

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The study schematic is presented in Figure 2.
Figure 2.
Study Schema
5-FU = 5-fluorouracil; HNSCC = head and neck squamous cell carcinoma; PD-L1 = programmed cell death ligand 1; 
RP2D = recommended Phase 2 dose
a
Optional cohort to be opened at the discretion of the sponsor.
b
A pre-expansion safety run-in evaluation of magrolimab + pembrolizumab may be conducted at the sponsor’s discretion 
prior to the initiation of this optional cohort.
3.1.1.
Safety Run-in
3.1.1.1.
Safety Run-in 1
A DLT evaluation period of 1 cycle (21 days) will occur. After 6 patients have completed the 
DLT-evaluation period, a decision will be made on further expansion or dose de-escalation (DLT 
definition is provided in Section 3.1.1.1.2).
Even though no dose-dependent toxicities have been observed with magrolimab, in order to 
preserve the efficacious dose of the combination partner drugs, dose de-escalation will take place 
for magrolimab. Dose de-escalation decisions will be made as follows:
•
If no more than 2 of 6 DLT-evaluable patients experience a DLT in Cycle 1, enrollment into 
Phase 2 Cohorts 1 and 2 will begin at this dose level.
Untreated 
metastatic or 
unresectable, 
locally 
recurrent 
HNSCC 
Untreated 
metastatic or 
unresectable, 
locally 
recurrent 
HNSCC 
(POL 1+ only) 
Metastatic or 
unresectable 
HNSCC 
previously 
treated with 1 
and no more 
than 2 lines of 
prior therapy 
Safety Run-in 1 
Magrolimab + 
Pembrolizumab + Platinum 
+ 5-FU 
N = up to 18 
Optional Phase 2 
Cohort 2a,b (single-arm) 
Safety 
evaluation 
&RP2D 
-
- -
-
- -
-
- -
-
- -
-
-
- -
-
- -
-
- -
-
- -
- -
-
- -
-
- -
-
- -
-
- -
-
- -
- -I 
Magrolimab + Pembrolizumab 
N = 25 
Phase 2 
' ' ' 
Delay 
Safety Run-in 2 
Cohort 3 (single-arm) 
Magrolimab 
+ Docetaxel 
N = up to 18 
Safety 
evaluation 
& RP2D 
Magrolimab 
+ Docetaxel 
N = 40 
Phase 2 
Cohort 1 (randomized) 
Arm A: Magrolimab + 
Pembrolizumab + Platinum + 
5-FU 
N = 66 
Arm B Pembrolizumab + 
Platinum + 5-FU 
N = 66 
Arm C: Magrolimab + 
Zimberelimab + Platinum + 
5-FU 
N = 46 

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•
If 3 or more (> 34%) DLT-evaluable patients experience a DLT at any time, another 
6 patients will be enrolled at a lower dose and will be evaluated in the same manner to define 
the recommended dose for the combination regimen.
Dose de-escalation for Safety Run-in 1 is presented in Table 2. Based on the totality of the data, 
alternative doses of magrolimab not described in Table 2 may be considered for dose 
de-escalation by the SRT and sponsor.
3.1.1.1.1.
Dose-Limiting Toxicity Assessment Period for Safety Run-in 1
The DLT assessment period will be the first cycle (21 days) and applies to Safety Run-in 1. 
Patients will be considered evaluable for assessment of DLTs if either of the following criteria is 
met during the DLT assessment period:
•
The patient experiences a DLT at any time after initiation of the first infusion of magrolimab.
•
The patient does not experience a DLT and completes at least 2 infusions of magrolimab and 
at least 1 dose of pembrolizumab, 1 dose of 5-FU, and 1 dose of platinum.
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 Safety Run-in 1 will be 
replaced.
Patients enrolled in Safety Run-in 1 will continue treatment until unacceptable toxicity or disease 
progression, whichever occurs first, and will not change their magrolimab dose level after the 
RP2D is determined.
3.1.1.1.2.
Dose-Limiting Toxicity Definition for Safety Run-in 1
All toxicities will be graded according to the National Cancer Institute (NCI) Common 
Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Appendix 4). A DLT is 
defined as an event meeting Hy’s Law criteria (Section 7.7), any Grade 3 or higher hematologic 
toxicity or Grade 3 or higher nonhematologic toxicity that has worsened in severity from 
pretreatment baseline during the DLT assessment period and, in the opinion of the investigator, 
the AE is related to magrolimab and the relationship of the AE with the combination partner 
regimen can be ruled out.
The following are exceptions to the DLT definition and are NOT considered a DLT:
•
Grade 3 anemia; however, Grade 3 hemolytic anemia that is medically significant, requiring 
hospitalization or prolongation of existing hospitalization, disabling, or limiting self-care 
activities of daily life is considered a DLT.
•
Grade 3 neutropenia that resolves to Grade 2 within 3 weeks with supportive care measures 
(ie, granulocyte colony-stimulating factor [G-CSF]) or Grade 4 neutropenia lasting for 7 days 
or less with supportive measures.

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•
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 with supportive 
care within 1 week and is not associated with other clinically significant consequences.
•
Isolated Grade 3 electrolyte abnormalities that resolve to ≤ Grade 2 with supportive care 
within 72 hours and are not associated with other clinically significant consequences.
•
Grade 3 elevation in alanine aminotransferase (ALT) and/or aspartate aminotransferase 
(AST) up to ≤ 8  upper limit of normal (ULN) lasting < 7 days. Grade 3 alkaline 
phosphatase that resolves to ≤ Grade 2 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 with supportive care within 
72 hours.
•
Grade 3 fatigue that resolves to ≤ Grade 2 within 2 weeks on study.
•
Grade 3 magrolimab, 5-FU, or platinum infusion reactions in the absence of an optimal 
pretreatment regimen, which is defined as acetaminophen or a comparable nonsteroidal 
anti-inflammatory agent plus, an antihistamine and corticosteroids.
•
Grade 3 tumor lysis syndrome or electrolyte disturbances (hyperkalemia, hypophosphatemia, 
hyperuricemia) that resolve to ≤ Grade 2 or baseline within 72 hours.
•
Grade 3 hypomagnesemia that resolves 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 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.
The RP2D will be determined by the sponsor based on all relevant clinical and PK data from all 
patients treated in Safety Run-in 1.
3.1.1.2.
Safety Run-in 2
Safety Run-in 2 will open for enrollment at the same time as Safety Run-in 1. A DLT evaluation 
period of 1 cycle (21 days) will occur. After 6 patients have completed the DLT evaluation 
period, a decision will be made on further expansion or dose de-escalation (DLT definition is 
provided in Section 3.1.1.2.1).

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Even though no dose-dependent toxicities have been observed with magrolimab, in order to 
preserve the efficacious dose of the combination partner drug, dose de-escalation will take place 
for magrolimab. Dose de-escalation decisions will be made as follows:
•
If no more than 2 of 6 DLT-evaluable patients experience a DLT in Cycle 1, enrollment into 
Phase 2 Cohort 3 will begin at this dose level.
•
If 3 or more (> 34%) DLT-evaluable patients experience a DLT at any time, another 
6 patients will be enrolled at a lower dose and will be evaluated in the same manner to define 
the recommended dose for the combination regimen.
Dose de-escalation for Safety Run-in 2 is presented in Table 6. Based on the totality of the data, 
alternative doses of magrolimab not described in Table 6 may be considered for dose 
de-escalation by the SRT and sponsor.
3.1.1.2.1.
Dose-Limiting Toxicity Assessment Period for Safety Run-in 2
The DLT assessment period will be the first cycle (21 days) and applies to Safety Run-in 2. 
Patients will be considered evaluable for assessment of DLTs if either of the following criteria is 
met during the DLT assessment period:
•
The patient experiences a DLT at any time after initiation of the first infusion of magrolimab.
•
The patient does not experience a DLT and completes at least 2 infusions of magrolimab and 
at least 1 dose of docetaxel.
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 Safety Run-in 2 will be 
replaced.
Patients enrolled in Safety Run-in 2 will continue treatment until unacceptable toxicity or disease 
progression, whichever occurs first, and will not change their magrolimab dose level after the 
RP2D is determined.
3.1.1.2.2.
Dose-Limiting Toxicity Definition for Safety Run-in 2
All toxicities will be graded according to the NCI CTCAE, Version 5.0 (Appendix 4). A DLT is 
defined as an event meeting Hy’s Law criteria (Section 7.7), any Grade 3 or higher hematologic 
toxicity or Grade 3 or higher nonhematologic toxicity that has worsened in severity from 
pretreatment baseline during the DLT assessment period and, in the opinion of the investigator, 
the AE is related to magrolimab and the relationship of the AE with the combination partner 
regimen can be ruled out.
The following are exceptions to the DLT definition and are NOT considered a DLT:
•
Grade 3 anemia; however, Grade 3 hemolytic anemia that is medically significant, requiring 
hospitalization or prolongation of existing hospitalization, disabling, or limiting self-care 
activities of daily life is considered a DLT.
•
Grade 3 neutropenia that resolves to Grade 2 within 3 weeks with supportive care measures 
(ie, G-CSF) or Grade 4 neutropenia lasting for 7 days or less with supportive measures.

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•
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 with supportive 
care within 1 week and is not associated with other clinically significant consequences.
•
Isolated Grade 3 electrolyte abnormalities that resolve to ≤ Grade 2 with supportive care 
within 72 hours and are not associated with other clinically significant consequences.
•
Grade 3 elevation in ALT and/or AST up to ≤ 8  ULN lasting < 7 days. Grade 3 alkaline 
phosphatase that resolves to ≤ Grade 2 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 with supportive care within 
72 hours.
•
Grade 3 fatigue that resolves to ≤ Grade 2 within 2 weeks on study.
•
Grade 3 magrolimab or docetaxel infusion reactions in the absence of an optimal 
pretreatment regimen, which is defined as acetaminophen or a comparable nonsteroidal anti-
inflammatory agent, plus an antihistamine and corticosteroids.
•
Grade 3 tumor lysis syndrome or electrolyte disturbances (hyperkalemia, hypophosphatemia, 
hyperuricemia) that resolve to ≤ Grade 2 or baseline within 72 hours.
•
Grade 3 hypomagnesemia that resolves 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 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.
The RP2D will be determined by the sponsor based on all relevant clinical and PK data from all 
patients treated in Safety Run-in 2.
3.1.1.3.
Pre-expansion Safety Run-in for Magrolimab + Pembrolizumab
If the sponsor determines that additional dose finding for magrolimab + pembrolizumab is 
needed, 6 patients will be enrolled to receive magrolimab + pembrolizumab in this safety run-in 
evaluation. A DLT evaluation period of 1 cycle (21 days) will occur (DLT definition is provided 
in Section 3.1.1.3.2).
Even though no dose-dependent toxicities have been observed with magrolimab, in order to 
preserve the efficacious dose of the combination partner drug, dose de-escalation will take place 
for magrolimab. Dose de-escalation decisions will be made as follows:

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•
If no more than 2 of 6 DLT-evaluable patients experience a DLT in Cycle 1, enrollment into 
Phase 2 Cohort 2 will begin at this dose level.
•
If 3 or more (> 34%) DLT-evaluable patients experience a DLT at any time, another 
6 patients will be enrolled at a lower dose and will be evaluated in the same manner to define 
the recommended dose for the combination regimen.
Dose de-escalation for the pre-expansion safety run-in evaluation for magrolimab + 
pembrolizumab is presented in Table 4.
3.1.1.3.1.
Dose-Limiting Toxicity Assessment Period for the Pre-expansion Safety Run-in 
for Magrolimab + Pembrolizumab
The DLT assessment period will be the first cycle (21 days) and applies to this safety run-in 
evaluation. Patients will be considered evaluable for assessment of DLTs if either of the 
following criteria is met during the DLT assessment period:
•
The patient experiences a DLT at any time after initiation of the first infusion of magrolimab.
•
The patient does not experience a DLT and completes at least 2 infusions of magrolimab and 
at least 1 dose of pembrolizumab.
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 this safety run-in will be 
replaced.
Patients enrolled in this safety run-in evaluation will continue treatment until unacceptable 
toxicity or disease progression, whichever occurs first, and will not change their magrolimab 
dose level after the RP2D is determined.
3.1.1.3.2.
Dose-Limiting Toxicity Definition for the Pre-expansion Safety Run-in for 
Magrolimab + Pembrolizumab
All toxicities will be graded according to the NCI CTCAE, Version 5.0 (Appendix 4). A DLT is 
defined as an event meeting Hy’s Law criteria (Section 7.7), any Grade 3 or higher hematologic 
toxicity or Grade 3 or higher nonhematologic toxicity that has worsened in severity from 
pretreatment baseline during the DLT assessment period and, in the opinion of the investigator, 
the AE is related to magrolimab and the relationship of the AE with the combination partner 
regimen can be ruled out.
The following are exceptions to the DLT definition and are NOT considered a DLT:
•
Grade 3 anemia; however, Grade 3 hemolytic anemia that is medically significant, requiring 
hospitalization or prolongation of existing hospitalization, disabling, or limiting self-care 
activities of daily life is considered a DLT.
•
Grade 3 neutropenia that resolves to Grade 2 within 3 weeks with supportive care measures 
(ie, G-CSF) or Grade 4 neutropenia lasting for 7 days or less with supportive measures.

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•
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 with supportive 
care within 1 week and is not associated with other clinically significant consequences.
•
Isolated Grade 3 electrolyte abnormalities that resolve to ≤ Grade 2 with supportive care 
within 72 hours and are not associated with other clinically significant consequences.
•
Grade 3 elevation in ALT and/or AST up to ≤ 8  the ULN lasting < 7 days. Grade 3 alkaline 
phosphatase that resolves to ≤ Grade 2 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 with supportive care within 
72 hours.
•
Grade 3 fatigue that resolves to ≤ Grade 2 within 2 weeks on study.
•
Grade 3 magrolimab or pembrolizumab infusion reactions in the absence of an optimal 
pretreatment regimen, which is defined as acetaminophen or a comparable nonsteroidal anti-
inflammatory agent, plus an antihistamine, and corticosteroids.
•
Grade 3 tumor lysis syndrome or electrolyte disturbances (hyperkalemia, hypophosphatemia, 
hyperuricemia) that resolve to ≤ Grade 2 or baseline within 72 hours.
•
Grade 3 hypomagnesemia that resolves 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 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.
The RP2D will be determined by the sponsor based on all relevant clinical and PK data from all 
patients treated in this safety run-in.
3.1.1.4.
Safety Review Team
An SRT will be established to assess safety of the patients in various cohorts.
The SRT will include at least 1 investigator, the Gilead Sciences (Gilead) medical monitor, and 
the Gilead Patient Safety (PS) physician. Others may be invited to participate as members of the 
SRT if additional expertise is desired (ie, representatives from Clinical Operations, Biostatistics, 

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Clinical Pharmacology, and Biomarker Sciences, as applicable). The medical monitor serves as 
the chair of the SRT. An SRT charter (or similar document) will be agreed on by all SRT 
members prior to the first SRT meeting. The data reviewed at the SRT meeting to make dose 
de-escalation decisions will be defined in the SRT charter (or similar document). The quality 
control checks performed on the data reviewed and used for making decisions will be described 
in the SRT charter (or similar document).
3.1.2.
Phase 2 Cohorts
Once the SRT reviews each safety run-in evaluation and the sponsor determines the RP2D for 
that study population, the following Phase 2 Cohorts will be conducted:
•
Phase 2 Cohort 1: a randomized, open-label cohort of magrolimab + pembrolizumab + 
platinum + 5-FU (Arm A) versus pembrolizumab + platinum + 5-FU (Arm B) versus a 
delayed open arm magrolimab + zimberelimab + platinum + 5-FU (Arm C) in patients with 
untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status.
•
Phase 2 Cohort 2: At the sponsor’s discretion, a cohort of magrolimab + pembrolizumab in 
patients with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 
CPS ≥ 1 may be opened.
•
Phase 2 Cohort 3: a cohort of magrolimab + docetaxel in patients with locally 
advanced/mHNSCC regardless of PD-L1 status who were previously treated with at least 
1 and no more than 2 lines of prior systemic therapy.
3.1.2.1.
Phase 2 Cohort 1
Once the SRT reviews Safety Run-in 1 and the sponsor determines the RP2D for magrolimab + 
pembrolizumab + platinum + 5-FU, a Phase 2, randomized, open-label cohort with a 
2-treatment-group design will open for enrollment. Approximately 132 patients with untreated 
metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will be 
randomized in a 1:1 ratio to receive either magrolimab + pembrolizumab + platinum + 5-FU 
(Arm A) or pembrolizumab + platinum + 5-FU (Arm B). The primary efficacy assessment will 
be PFS by as determined by investigator assessment, with the primary analysis to occur after 93 
events. Stratification factors for randomization include the following:
•
PD-L1 expression (CPS ≥ 1 versus CPS < 1)
•
p16 status (positive versus negative)
Once the Phase 2 Cohort 1 enrolls 20 patients in each arm, a third arm will open: magrolimab + 
zimberelimab + platinum + 5-FU (Arm C; n = 46). Randomization will continue 1:1:1 across all 
3 arms, with the same stratification factors.
3.1.2.2.
Phase 2 Cohort 2
Dose finding for magrolimab + pembrolizumab alone (without chemotherapy) may be performed 
by the sponsor, as needed. An optional Phase 2 Cohort 2 will open for enrollment once the RP2D 
for magrolimab + pembrolizumab is determined. Approximately 25 patients with untreated 

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metastatic or unresectable, locally recurrent HNSCC with a PD-L1 CPS ≥ 1 will be enrolled to 
receive magrolimab + pembrolizumab. The primary efficacy assessment will be 
investigator-assessed ORR.
3.1.2.3.
Phase 2 Cohort 3
Once the SRT reviews Safety Run-in 2 and the sponsor determines the RP2D for magrolimab + 
docetaxel, the Phase 2 Cohort 3 will open for enrollment. Approximately 40 patients with locally 
advanced/mHNSCC regardless of PD-L1 status who were previously treated with at least 1 and 
no more than 2 lines of prior systemic therapy will be enrolled to receive magrolimab + 
docetaxel. The primary efficacy assessment will be investigator-assessed ORR.
3.1.3.
Diagnostic Tissue Testing
Tumor expression of PD-L1 will be evaluated prospectively using an assay approved by the FDA 
for detection of PD-L1 in HNSCC tissues.
Testing for p16 HPV positivity will be performed by immunohistochemistry analysis using the 
CINtec® Histology (p16) assay (Ventana Medical Systems, Inc., Tucson, AZ). A central 
laboratory may be used if testing as specified is not available locally. Oral cavity, hypopharynx, 
and larynx cancers are not required to undergo HPV testing by immunohistochemistry, as by 
convention they are assumed to be HPV negative.
3.2.
Study Treatments
3.2.1.
Safety Run-in 1, Pre-expansion Safety Run-in for Magrolimab + 
Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2
Study treatments for Safety Run-in 1 and Phase 2 Cohort 1 are summarized in Table 2 and 
Table 3, respectively. For platinum usage, cisplatin or carboplatin can be used per investigator 
choice. The schedules of assessments are provided in Appendix 2.

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Table 2.
Safety Run-in 1: Dose De-escalation
Dose Schedule (Day per 21-Day Cycle)
Dose Level
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 30 mg/kg IV (2 h ± 30 min)
Days 8 and 
15
Days 1, 8, and 
15
—
Magrolimab 60 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Pembrolizumab 200 mg IV (30 min ± 10 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Starting dose
Cisplatin 100 mg/m2 IV (1 h) 
or 
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 20 mg/kg IV (2 h ± 30 min)
Days 8 and 
15
Days 1, 8, and 
15
—
Magrolimab 45 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Pembrolizumab 200 mg IV (30 min ± 10 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Level minus 
1
Cisplatin 100 mg/m2 IV (1 h) 
or 
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 15 mg/kg IV (2 h ± 30 min)
Days 8 and 
15
Days 1, 8, and 
15
—
Magrolimab 30 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Pembrolizumab 200 mg IV (30 min ± 10 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Level minus 
2
Cisplatin 100 mg/m2 IV (1 h) 
or 
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
5-FU = 5-fluorouracil; IV = intravenous

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Table 3.
Phase 2 Cohort 1: Dose Level and Schedule
Dose Schedule (Day per 21-Day Cycle)
Treatment Group
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimaba IV (2 h ± 30 min)
Days 8 and 15
Days 1, 8, and 15
—
Magrolimaba IV (2 h ± 30 min)
—
—
Day 1
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Magrolimab + 
pembrolizumab + 
platinum + 5-FU
Cisplatin 100 mg/m2 IV (1 h) 
or 
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Pembrolizumab + 
platinum + 5-FU
Cisplatin 100 mg/m2 IV (1 h) 
or 
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimaba IV (2 h ± 30 min)
Days 8 and 15
Days 1, 8, and 15
—
Magrolimaba IV (2 h ± 30 min)
—
—
Day 1
Zimberelimab 360 mg IV (60 min ± 15 
min)
Day 1
Day 1
Day 1
5-FU 1000 mg/m2/day continuous IV
Days 1-4
Days 1-4
Days 1-4
Cycles 3-6
Magrolimab + 
Zimberelimab + 
platinum + 5-FU 
Cisplatin 100 mg/m2 IV (1 h)
or
Carboplatin AUC 5 IV (1 h)
Day 1
Day 1
Day 1 
Cycles 3-6
5-FU = 5-fluorouracil; IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in Safety Run-in 1, as described in Table 2.
If the sponsor determines that additional dose finding for magrolimab + pembrolizumab (alone 
without chemotherapy) is needed, all patients in the pre-expansion safety run-in evaluation will 
receive magrolimab + pembrolizumab. Study treatments for the pre-expansion safety run-in for 
magrolimab + pembrolizumab and Phase 2 Cohort 2 are summarized in Table 4 and Table 5, 
respectively. The schedules of assessments are provided in Appendix 2.

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Table 4.
Pre-expansion Safety Run-in for Magrolimab + Pembrolizumab: Dose 
De-escalation
Dose Schedule (Day per 21-Day Cycle)
Dose Level
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 30 mg/kg IV (2 h ± 30 min)
Days 8 and 
15
Days 1, 8, 
and 15
—
Magrolimab 60 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Starting dose
Pembrolizumab 200 mg IV (30 min ± 10 min)
Day 1
Day 1
Day 1
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 20 mg/kg IV (2 h ± 30 min)
Days 8 and 
15
Days 1, 8, 
and 15
—
Magrolimab 45 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Level minus 1
Pembrolizumab 200 mg IV (30 min ± 10 min)
Day 1
Day 1
Day 1
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 15 mg/kg IV (2 h ± 30 min)
Days 8 and 
15
Days 1, 8, 
and 15
—
Magrolimab 30 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Level minus 2
Pembrolizumab 200 mg IV (30 min ± 10 min)
Day 1
Day 1
Day 1
IV = intravenous
Table 5.
Phase 2 Cohort 2: Dose Level and Schedule
Dose Schedule (Day per 21-Day Cycle)
Treatment 
Group
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimaba IV (2 h ± 30 min)
Days 8 and 
15
Days 1, 8, and 
15
—
Magrolimaba IV (2 h ± 30 min)
—
—
Day 1
Magrolimab + 
pembrolizumab
Pembrolizumab 200 mg IV 
(30 min ± 10 min)
Day 1
Day 1
Day 1
IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in the pre-expansion safety run-in for magrolimab + pembrolizumab (if applicable), as described in 
Table 4.
3.2.2.
Safety Run-in 2 and Phase 2 Cohort 3
Study treatments for Safety Run-in 2 and Phase 2 Cohort 3 are summarized in Table 6 and 
Table 7, respectively. The schedules of assessments are provided in Appendix 2.

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Table 6.
Safety Run-in 2: Dose De-escalation
Dose Schedule (Day per 21-Day Cycle)
Dose Level
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 30 mg/kg IV (2 h ± 30 min)
Days 8 and 15
Days 1, 8, and 15
—
Magrolimab 60 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Starting dose
Docetaxel 75 mg/m2 IV (1 h ± 5 min)
Day 1
Day 1
Day 1
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 20 mg/kg IV (2 h ± 30 min)
Days 8 and 15
Days 1, 8, and 15
—
Magrolimab 45 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Level minus 1
Docetaxel 75 mg/m2 IV (1 h ± 5 min)
Day 1
Day 1
Day 1
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimab 15 mg/kg IV (2 h ± 30 min)
Days 8 and 15
Days 1, 8, and 15
—
Magrolimab 30 mg/kg IV (2 h ± 30 min)
—
—
Day 1
Level minus 2
Docetaxel 75 mg/m2 IV (1 h ± 5 min)
Day 1
Day 1
Day 1
IV = intravenous
Table 7.
Phase 2 Cohort 3: Dose Level and Schedule
Dose Schedule (Day per 21-Day Cycle)
Treatment 
Group
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Magrolimab 1 mg/kg IV (3 h ± 30 min)
Day 1
—
—
Magrolimaba IV (2 h ± 30 min)
Days 8 and 15
Days 1, 8, and 15
—
Magrolimaba IV (2 h ± 30 min)
—
—
Day 1
Magrolimab + 
docetaxel
Docetaxel 75 mg/m2 IV (1 h ± 5 min)
Day 1
Day 1
Day 1
IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in Safety Run-in 2, as described in Table 6.
3.3.
Duration of Treatment
Cycle length is 21 days for all cohorts. Magrolimab and docetaxel will be continued until loss of 
clinical benefit, unacceptable toxicity, or death. Pembrolizumab and zimberelimab therapies will 
be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, 
whichever occurs first. Platinum + 5-FU will be administered for up to 6 cycles or until loss of 
clinical benefit or unacceptable toxicity, whichever occurs first.
Patients may continue treatment unless they develop unacceptable toxicity that cannot be 
clinically managed by dose or schedule modifications or if they have confirmed progressive 
disease according to immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). 
If any drug from the combination regimen is discontinued for reasons other than disease 
progression, the remaining drug(s) in the combination regimen may be continued. Patients are 

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not required to discontinue study drug for disease progression per RECIST criteria, given the 
observation that delayed clinical benefit can occur with immune therapies beyond initial disease 
progression. Treatment with study drug may continue past the initial determination of disease 
progression according to irRECIST if the following criteria are met:
•
No new symptoms or worsening of previous symptoms
•
Tolerance of magrolimab + pembrolizumab + platinum + 5-FU, magrolimab + zimberelimab 
+ platinum + 5-FU, magrolimab + pembrolizumab, or magrolimab + docetaxel
•
Stable Eastern Cooperative Oncology Group (ECOG) performance status
•
Treatment beyond progression will not delay an imminent intervention to prevent serious 
complications of disease progression (eg, central nervous metastases).
The decision to continue treatment should be approved by the sponsor.
3.4.
Discontinuation Criteria
Reasons for discontinuation of study treatment may include, but are not limited to, the following:
•
Disease progression by irRECIST (treatment beyond disease progression by irRECIST is 
allowed per criteria in Section 3.3)
•
Unacceptable toxicity
•
Loss of clinical benefit
•
Clinically significant change in the patient’s status that precludes further treatment 
(eg, pregnancy or other AEs)
•
Patient request, with or without a stated reason
•
Patient noncompliance
•
Discontinuation of the study at the request of Gilead, a regulatory agency, or an institutional 
review board (IRB) or independent ethics committee (IEC)
•
Investigator or treating physician decision in the absence of any of the above
Although disease progression is considered a sufficient reason for discontinuing a patient from 
study treatment, given the delayed treatment benefit commonly seen in immune therapies, the 
investigator is advised to continue to treat the patient until the confirmation of disease 
progression through a subsequent response assessment at least 4 weeks apart (ie, disease 
worsening compared to the previous assessment), or until the investigator considers the study 
treatment to be no longer clinically beneficial to the patient, or the change of disease state 
renders the patient unacceptable for further treatment in the judgment of the investigator. Patients 
may continue study treatment beyond irRECIST disease progression in accordance with criteria 
in Section 3.3. All patients must be followed through completion of all study treatment.

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3.5.
Discontinuation From Study Criteria/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, 
or 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
Upon withdrawal from study treatment, patients will receive the care upon which they and their 
physicians agree. Patients will be followed for disease progression if applicable, subsequent 
therapy, and response to subsequent therapy, survival, and AEs as specified in Appendix Table 2. 
See Appendix 12 for poststudy care considerations in France.
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, and interactive response technology 
(IRT).
3.8.
Biomarker Samples to Address the Study Objectives
Peripheral blood and tumor biopsy samples will be collected from all patients who have provided 
consent to participate in this study. They may be used to evaluate the association of systemic 
and/or tissue-based biomarkers with study drug response, including efficacy and/or AEs, dosage 
selection, and to better understand the biology of the cancer indication studied, as well as the 
efficacy and mechanism of action for magrolimab combinations. Because biomarker science is a 
rapidly evolving area of investigation, and AEs in particular are difficult to predict, it may not be 
possible to specify prospectively all tests that may be done on the specimens provided. The 
specific analyses will include, but may not be limited to, the biomarkers and assays described 
below. The testing outlined below is based upon the current state of scientific knowledge. It may 
be modified during or after the end of the study to remove tests no longer indicated and/or to add 
new tests based upon new state of the art knowledge.
Biomarker assessments will include, but will not be limited to, the following:
•
Blood sample for RO (at select sites)
•
Circulating tumor DNA sample to monitor treatment response

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•
Peripheral blood mononuclear cell (PBMC) to assess immune cell phenotypes
•
Serum and plasma biomarker samples for the analysis of circulating factors such as 
cytokines, soluble immune receptors, and antibodies
•
Whole blood RNA samples for leukocyte gene expression analysis
•
Immunophenotyping assays
•
T-cell receptor sequencing sample to assess immune repertoire changes
•
Stool samples to assess microbiome
•
Mandatory baseline tumor tissue and on-treatment biopsy to assess immune cells, tumor cell 
surface proteins, and/or genomic biomarkers
Blood and tumor biopsy samples will be collected to measure biomarkers, which may include, 
but will not be limited to, the presence of or changes to immune cell populations, secreted 
protein factors, the expression of cell surface markers on either tumor cells or cells of the tumor 
microenvironment, and genetic mutations in tumor cells or subclones of tumor cells at the time 
points listed in the schedules of assessments (Appendix 2).
Blood and tumor samples will also be used for genomic research. In addition, a whole blood 
genomic sample will be collected at Cycle 1 Day 1 but may be collected at any time during the 
study, if necessary. These samples will be used to identify or validate genetic markers that may 
increase our knowledge and understanding of the biology of the study disease and related 
diseases and to study the association of genetic markers with disease pathogenesis, progression, 
and/or treatment outcomes, including efficacy, AEs, and the processes of drug absorption and 
disposition. These specimens may also be used to develop biomarker or diagnostic assays and 
establish the performance characteristics of these assays. Genomics research may include 
sequencing of genetic material derived from both cancer cells and normal cells. Sequencing of 
genetic material derived from cancer cells will be used to better understand the mechanism of 
action of magrolimab combinations in this patient population and to potentially to identify 
subsets of patients who are likely to benefit. Sequencing of genetic material derived from normal 
cells will be used to define differences in sequence that are cancer specific.
Samples collected for biomarker assessments will be destroyed no later than 15 years after the 
end of study or per country requirements.
CCI

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CCI

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4.
PATIENT POPULATION
4.1.
Number of Patients and Patient Selection
Approximately 230 and up to 297 patients may be enrolled in the study, with at least 12 and up to 
54 patients in total in Safety Run-ins 1 and 2, and optional Pre-expansion Safety Run-in for 
Cohort 2; approximately 178 patients in Phase 2 Cohort 1; approximately 25 patients in optional 
Phase 2 Cohort 2; and approximately 40 patients in Phase 2 Cohort 3.
4.1.1.
Patient Replacement
Patients may be replaced in the safety run-in evaluations if not evaluable for DLT assessment, as 
described in Section 3.1.1.
4.2.
Inclusion Criteria
All Patients
All patients must meet all of the following inclusion criteria to be eligible for participation in this 
study:
1) Patient has provided informed consent.
2) Patient is willing and able to comply with clinic visits and procedures outlined in the study 
protocol.
3) Male or female ≥ 18 years of age.
4) ECOG performance status of ≤ 1.
5) Laboratory measurements, blood counts:
a) Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment. Red blood cell 
transfusions are allowed to meet hemoglobin eligibility within limits set per Exclusion 
Criterion #6 (and per Section 7.8.1.2).
b) Absolute neutrophil count (ANC) ≥ 1.5  109/L.
c) Platelets ≥ 100  109/L.
6) Laboratory measurements, renal function:
a) Serum creatinine ≤ 1.5  ULN or if elevated, a calculated glomerular filtration rate 
> 40 mL/min/1.73 m2.
7) Laboratory measurements, hepatic function:
a) AST and ALT ≤ 2.5  ULN or ≤ 5  ULN in patients with liver metastases.
b) Total bilirubin ≤ 1.5  ULN or ≤ 3.0  ULN and primarily unconjugated if patient has a 
documented history of Gilbert’s syndrome or genetic equivalent.

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8) Laboratory measurements, coagulation function:
a) International normalized ratio or prothrombin time (PT) ≤ 1.5  ULN unless patient is 
receiving anticoagulation therapy, as long as PT or partial thromboplastin time (PTT) is 
within therapeutic range of intended use for anticoagulants.
b) Activated partial thromboplastin time or PTT ≤ 1.5  ULN unless patient is receiving 
anticoagulation therapy, as long as PT or PTT is within therapeutic range of intended use 
for anticoagulants.
9) Pretreatment blood cross-match completed (Section 7.8.1.1).
10) Male and female patients of childbearing potential who engage in heterosexual intercourse 
must agree to use protocol-specified method(s) of contraception, as described in Appendix 5.
11) Measurable disease according to RECIST, Version 1.1.
12) Note: Inclusion Criterion #12 was removed in Protocol Amendment 3 and relocated to 
Inclusion Criterion #13d.
Safety Run-in 1, Pre-expansion Safety Run-in for Magrolimab + Pembrolizumab (if Applicable), 
and Phase 2 Cohorts 1 and 2
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into 
Safety Run-in 1, the pre-expansion safety run-in for magrolimab + pembrolizumab (if 
applicable), and Phase 2 Cohorts 1 and 2 must fulfill the following cohort-specific inclusion 
criterion:
13) Histologically or cytologically confirmed metastatic or locally recurrent HNSCC that is 
considered incurable by local therapies
a) Patients should not have had prior systemic therapy administered in the recurrent or 
metastatic setting. Systemic therapy that was completed more than 6 months prior to 
signing consent if given as part of multimodal treatment for locally advanced disease is 
allowed.
b) Eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and 
larynx.
c) Patients may not have a primary tumor site of nasopharynx (any histology).
d) Patients must be willing to provide baseline tumor tissue from a core or excisional biopsy 
(fine needle aspirate is not adequate). A newly obtained biopsy (within 90 days prior to 
study treatment start) is strongly preferred, but an archival sample is acceptable. For 
archival samples submitted in lieu of newly obtained biopsies, tissue collected within 
6 months prior to study treatment start is strongly preferred whenever possible. Patients 
will also be requested to consent to a mandatory on-treatment tumor biopsy, unless not 
feasible as determined by the investigator and discussed with the sponsor.

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Safety Run-in 1 and Phase 2 Cohort 1
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into 
Safety Run-in 1 and Phase 2 Cohort 1 must fulfill the following cohort-specific inclusion 
criterion:
14) Patients with HNSCC per Inclusion Criterion #13 regardless of PD-L1 status.
Pre-expansion Safety Run-in for Magrolimab + Pembrolizumab (if Applicable) and Phase 2 
Cohort 2
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into the 
pre-expansion safety run-in for magrolimab + pembrolizumab (if applicable) and Phase 2 
Cohort 2 must fulfill the following cohort-specific inclusion criterion:
15) Patients with HNSCC per Inclusion Criterion #13 with a PD-L1 CPS ≥ 1.
Safety Run-in 2 and Phase 2 Cohort 3
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into 
Safety Run-in 2 and Phase 2 Cohort 3 must fulfill the following cohort-specific inclusion 
criterion:
16) Patients with histologically or cytologically confirmed locally advanced/mHNSCC regardless 
of PD-L1 status with at least 1 and no more than 2 lines of prior systemic anticancer therapy 
in the locally advanced/metastatic setting
a) Eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and 
larynx.
b) Patients may not have a primary tumor site of nasopharynx (any histology).
c) Prior systemic anticancer therapy for locally advanced/mHNSCC should consist of at 
least 1 line of platinum-based chemotherapy, with or without a PD-1 inhibitor. For 
patients with CPS ≥ 1 HNSCC, prior systemic anticancer therapy for locally 
advanced/mHNSCC should have included at least one line of PD-1 inhibitor-based 
therapy unless medically contraindicated.
4.3.
Exclusion Criteria
All Patients
Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this 
study:
1) Prior radiation therapy (or other nonsystemic therapy) within 2 weeks prior to enrollment. 
Patients who are candidates for curative radiation therapy are not eligible.

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2) Patient has not fully recovered (ie, ≤ Grade 1 at baseline) from AEs due to a previously 
administered treatment.
a) Note: Patients with ≤ Grade 2 neuropathy, ≤ Grade 2 alopecia, or laboratory values in 
inclusion criteria 5 through 8 are exceptions to this criterion and may qualify for the 
study.
b) Note: If a patient received major surgery, he or she must have recovered adequately from 
the toxicity and/or complications from the intervention prior to starting therapy.
3) Positive serum pregnancy test (Appendix 5).
4) Breastfeeding female.
5) Active CNS disease (patients with asymptomatic and stable, treated CNS lesions who have 
been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not 
considered active).
6) Red blood cell transfusion dependence, defined as requiring more than 2 units of packed 
RBC transfusions during the 4-week period prior to screening. Red blood cell transfusions 
are permitted during the screening period and prior to enrollment to meet the hemoglobin 
inclusion criterion.
7) History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 
3 months.
8) Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient. 
a) For Phase 2 Cohort 1, complete absence of dihydropyrimidine dehydrogenase (DPD) 
activity. If DPD status is not known, testing for DPD status should be done during the 
screening period where such testing is standard of care.
9) Prior treatment with CD47 or SIRPα-targeting agents.
10) Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or 
investigational agents within 4 weeks prior to magrolimab treatment.
11) Life expectancy of less than 3 months and/or rapidly progressing disease (eg, tumor bleeding, 
uncontrolled tumor pain) in the opinion of the treating investigator.
12) Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of 
immunosuppressive therapy within 7 days prior to the first dose of study therapy. 
Corticosteroid use as a premedication for allergic reactions or for prophylactic management 
of AEs related to the chemotherapies specified in the protocol is allowed. The use of 
physiologic doses of corticosteroids may be approved with approval by the sponsor.
13) Active autoimmune disease that has required systemic treatment in the past 2 years (ie, use of 
disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement 
therapy (eg, thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or 
pituitary insufficiency) is not considered a form of systemic treatment.

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14) Prior allogeneic tissue/solid organ transplant.
15) History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
16) Active, uncontrolled infection or infection requiring systemic therapy within ≤ 7 days of 
study entry.
17) Live vaccine within 30 days of start of study treatment.
18) Current participation in another interventional clinical study.
19) Known inherited or acquired bleeding disorders.
20) Significant disease or medical conditions, as assessed by the investigator and sponsor, that 
would substantially increase the risk-benefit ratio of participating in the study. This includes, 
but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, 
uncontrolled diabetes mellitus, significant active infections, and congestive heart failure 
New York Heart Association Class III-IV.
21) Second malignancy, except treated basal cell or localized squamous skin carcinomas, 
localized prostate cancer, or other malignancies for which patients are not on active 
anticancer therapies and who are in complete remission for over 5 years.
22) In patients with known history of HIV, presence of detectable viral load. HIV testing will be 
performed at screening only if required by local guidelines or institutional standards.
23) Known positivity for hepatitis B or C infection. Patients not currently on antiviral therapy 
and who have an undetectable viral load in the prior 3 months may be eligible for the study. 
Hepatitis B or C testing is not required. Patients with serologic evidence of prior vaccination 
to hepatitis B virus (ie, hepatitis B surface antigen negative and antibody against hepatitis B 
surface antigen positive) may participate.
Safety Run-in 1, Pre-expansion Safety Run-in for Magrolimab + Pembrolizumab (if Applicable), 
and Phase 2 Cohorts 1 and 2
Patients who meet any of the following exclusion criteria are not eligible to be enrolled into 
Safety Run-in 1, the pre-expansion safety run-in for magrolimab + pembrolizumab (if 
applicable), or Phase 2 Cohorts 1 and 2:
24) Progressive disease within 6 months of completion of curatively intended treatment for 
locoregionally advanced HNSCC.
25) Prior treatment with any of the following:
a) Anti–PD-1 or anti–PD-L1 checkpoint inhibitors.
b) Anti–cytotoxic T-lymphocyte–associated protein 4 checkpoint inhibitors.

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Safety Run-in 2 and Phase 2 Cohort 3
Patients who meet any of the following exclusion criteria are not eligible to be enrolled into 
Safety Run-in 2 or Phase 2 Cohort 3:
26) Progressive disease within 6 months of completion of curatively intended treatment for 
locally advanced/mHNSCC.
27) Prior treatment with a taxane.

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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Randomization, Blinding, and Treatment Codes Access
5.1.1.
Randomization
Patients in Phase 2 Cohort 1 of the study who meet eligibility criteria will be randomized in a 
1:1 ratio to receive either magrolimab + pembrolizumab + platinum + 5-FU (Arm A) or 
pembrolizumab + platinum + 5-FU (Arm B) using an IRT. The first dose on Day 1 must be 
administered within 3 days of randomization. Once the Phase 2 Cohort 1 enrolls 20 patients in 
each arm, a third arm will open: magrolimab + zimberelimab + platinum + 5-FU (Arm C). 
Randomization will continue 1:1:1 across all 3 arms.
Randomization will be stratified by the following: 1) PD-L1 expression (CPS ≥ 1 versus CPS < 1) 
and 2) p16 status (positive versus negative).
5.1.2.
Blinding
Blinding of treatment assignments or data will not be performed in this open-label study.
5.2.
Description and Handling of Magrolimab
5.2.1.
Formulation
Magrolimab is formulated as a sterile, clear, preservative-free liquid intended for IV 
administration containing 10 mM sodium acetate, 5% (weight-to-volume ratio [w/v]) sorbitol, 
0.01% (w/v) polysorbate 20 at pH of 5.0. Each vial is manufactured to ensure a deliverable 
volume of 10 mL containing 200 mg of magrolimab at a concentration of 20 mg/mL.
5.2.2.
Packaging and Labeling
Magrolimab is supplied in single-use, 10-mL glass vials with coated elastomeric stoppers and 
aluminum crimp overseals with a flip-off cap.
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, European Union (EU) Guidelines to 
Good Manufacturing Practice, Annex 13 (Investigational Medicinal Products), and/or other local 
regulations.
5.2.3.
Storage and Handling
Magrolimab should be stored at 2 °C to 8 °C (36 °F-46 °F). Magrolimab should not be frozen. 
Protect from light during storage. Do not shake. Storage conditions are specified on the label. 
Until dispensed to the patients, study drugs should be stored in a securely locked area, accessible 
only to authorized site personnel.
To ensure the stability and proper identification, study drug(s) should not be stored in a container 
other than the container in which they were supplied.

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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 Pembrolizumab
5.3.1.
Formulation
Pembrolizumab is commercially sourced. Information regarding the formulation can be found in 
the current country-specific prescribing information.
5.3.2.
Packaging and Labeling
Commercial product of pembrolizumab will be used for this study. 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 13 (Investigational Medicinal Products), 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
Pembrolizumab is commercially sourced. Further information regarding storage and handling 
can be found in the current country-specific prescribing information.
5.4.
Description and Handling of Zimberelimab
5.4.1.
Formulation
Zimberelimab Injection, 30 mg/mL drug product will be supplied as a sterile, preservative-free, 
clear, colorless, and slightly opalescent solution for IV administration. The drug product is 
composed of 30 mg/mL zimberelimab in 20 mM histidine/histidine-HCl, 150 mM sucrose, 
45 mM NaCl, 0.02% (weight/volume) polysorbate 80 at pH 5.5.
5.4.2.
Packaging and Labeling
Zimberelimab Injection, 30 mg/mL drug product is filled in single-use, 8R, Type I clear glass 
vials with coated elastomeric stoppers and capped with polypropylene flip-off caps with 
aluminum overseals.
Study drug 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 13 (Investigational Medicinal Products), and/or other local regulations.
5.4.3.
Storage and Handling
Zimberelimab should be stored at 2 °C to 8 °C (36 °F-46 °F). Zimberelimab should not be frozen 
and should be protected from light during storage. Until dispensed to the patients, study drugs 
should be stored in a securely locked area, accessible only to authorized site personnel. To 
ensure the stability and proper identification, study drug(s) should not be stored in a container 

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other than the container in which they were supplied. 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.
5.5.
 Description and Handling of 5-Fluorouracil
5.5.1.
Formulation
5-Fluorouracil is commercially sourced. Information regarding the formulation can be found in 
the current country-specific prescribing information.
5.5.2.
Packaging and Labeling
Commercial product of 5-FU will be used for this study. 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 13 
(Investigational Medicinal Products), and/or other local regulations. Alternatively, in alignment 
with local regulations, commercial product may be sourced locally by the sites.
5.5.3.
Storage and Handling
5-Fluorouracil is commercially sourced. Further information regarding storage and handling can 
be found in the current country-specific prescribing information.
5.6.
Description and Handling of Cisplatin
5.6.1.
Formulation
Cisplatin is commercially sourced. Information regarding the formulation can be found in the 
current country-specific prescribing information.
5.6.2.
Packaging and Labeling
Commercial product of cisplatin will be used for this study. 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 13 
(Investigational Medicinal Products), and/or other local regulations. Alternatively, in alignment 
with local regulations, commercial product may be sourced locally by the sites.
5.6.3.
Storage and Handling
Cisplatin is commercially sourced. Further information regarding storage and handling can be 
found in the current country-specific prescribing information.
5.7.
Description and Handling of Carboplatin
5.7.1.
Formulation
Carboplatin is commercially sourced. Information regarding the formulation can be found in the 
current country-specific prescribing information.

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5.7.2.
Packaging and Labeling
Commercial product of carboplatin will be used for this study. 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 13 
(Investigational Medicinal Products), and/or other local regulations. Alternatively, in alignment 
with local regulations, commercial product may be sourced locally by the sites.
5.7.3.
Storage and Handling
Carboplatin is commercially sourced. Further information regarding storage and handling can be 
found in the current country-specific prescribing information.
5.8.
Description and Handling of Docetaxel
5.8.1.
Formulation
Docetaxel is commercially sourced. Information regarding the formulation can be found in the 
current country-specific prescribing information.
5.8.2.
Packaging and Labeling
Commercial product of docetaxel will be used for this study. 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 13 
(Investigational Medicinal Products), and/or other local regulations. Alternatively, in alignment 
with local regulations, commercial product may be sourced locally by the sites.
5.8.3.
Storage and Handling
Docetaxel is commercially sourced. Further information regarding storage and handling can be 
found in the current country-specific prescribing information.
5.9.
Dosage and Administration of Magrolimab
The magrolimab dosing regimen for each cohort is presented in Table 2 to Table 7.
Magrolimab should be administered as outlined in the Pharmacy Manual for the study. The dose 
of magrolimab will be calculated based on actual weight at enrollment (using weight obtained 
either at screening or on Day 1) and will remain constant throughout the study, unless there is a 
> 10% change in weight from baseline. Modifications to the study drug doses administered 
should be made for a > 10% change in body weight and/or according to local and regional 
prescribing standards. Dose modifications for changes in body weight ≤ 10% may be made 
according to local institutional guidelines.
The duration of the first magrolimab (priming) infusion will be 3 hours (± 30 minutes). For 
subsequent doses, the magrolimab (maintenance) infusion will be 2 hours (± 30 minutes). The 
reduced infusion time to 2 hours is utilized based on prior data demonstrating majority CD47 RO 
on peripheral blood cells, thus mitigating anticipated RBC toxicities from magrolimab.

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Magrolimab doses will be given weekly during Cycles 1 and 2. Magrolimab will then be 
administered every 3 weeks during Cycle 3 and beyond. Magrolimab doses are not to be given 
on consecutive days.
When magrolimab is given in combination with pembrolizumab + platinum + 5-FU 
chemotherapy, zimberelimab + platinum + 5-FU, pembrolizumab, or docetaxel, magrolimab will 
be infused first. All patients should be monitored for 1 hour after infusion for priming, repriming, 
and maintenance doses during Cycle 1. Postinfusion monitoring should begin after the infusion is 
complete but prior to administering any other study drug. Postinfusion monitoring is not required 
for doses after Cycle 1 Day 15. Patients who experience any treatment-emergent AEs during the 
observation period should be further monitored, as clinically appropriate. Refer to Section 7.8.1.2 
for postinfusion hemoglobin and hematocrit reporting requirements.
Patients may continue study treatment until they show evidence of disease progression, relapse, 
loss of clinical benefit, or unacceptable toxicity (further details about treatment discontinuation 
are provided in Section 3.4).
Treatment Delay and Repriming for Magrolimab
Given the large CD47 antigen sink on normal cells, patients who have a prolonged dose delay of 
magrolimab are required to be reprimed with magrolimab dosing to resaturate the CD47 antigen 
sink. Guidelines for repriming for magrolimab after a dose delay are provided in Section 5.9.1.
5.9.1.
Dose Modifications and Delays for Magrolimab
In most circumstances, the dose of magrolimab should not be reduced. Clinical safety and PK 
data from dose finding studies in both solid tumor and hematologic malignancies have not 
demonstrated any dose-dependent toxicities associated with magrolimab.
Magrolimab should be withheld for any treatment-related Grade 4 AE, Grade 3 hemolytic 
anemia that is medically significant (requiring hospitalization or prolongation of existing 
hospitalization, disabling, or limiting self-care activities of daily life) or unmanageable any-grade 
toxicity. Magrolimab may be reintroduced once the severity is Grade ≤ 2 or baseline. Depending 
on the duration of the dose hold, repriming may be required as outlined in Table 8. See also 
Section 7.8.1.6 regarding magrolimab dose delays for severe neutropenia and Section 7.8.1.7 
regarding magrolimab dose delays for serious infections.
When combination drug treatment is delayed due to toxicities, magrolimab should be continued 
independently as per the magrolimab administration schedule. Continuous dosing of magrolimab 
is needed to maintain efficacious exposures and optimal efficacy. During the maintenance phase 
(Cycle 3 onward), if the last dose of magrolimab was administered within the previous 10 to 
20 days, the subsequent magrolimab dose may be administered earlier than scheduled in order to 
synchronize with the backbone combination drug administration.
The repriming guidelines shown in Table 8 should be followed for patients with dose delays. 
During repriming, efficacy, biomarker, PK, and immunogenicity assessments should follow the 
schedule of the assigned cycle number. Magrolimab dosing and safety assessments should follow 
Cycle 1 (refer to Table 2 to Table 7, as appropriate) and then subsequently switch back to the 

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assigned cycle schedule (Appendix Table 1). If repriming is necessary before the patient 
completes Cycle 1 or Cycle 2, the repriming cycle is administered by repeating Cycle 1 dosing, 
followed by Cycle 2 before proceeding to Cycle 3.
Criteria for permanent discontinuation of magrolimab include the following:
•
Grade 4 IRR, or recurrent Grade 3 IRR despite premedication, as per Section 7.8.1.3
•
Grade 4 nonhematologic AE related to magrolimab that does not improve to Grade 2 or 
baseline within 30 days
If magrolimab is discontinued for reasons other than disease progression, the remaining drug(s) 
in the combination regimen may be continued. Magrolimab may be withheld if 
treatment-emergent and/or magrolimab-related AEs occur, until clinical resolution or 
improvement per the treating physician.
Treatment delays (not due to AEs) of more than 4 weeks (such as an unrelated medical condition 
with expected recovery) must be approved by the sponsor.
Table 8.
Repriming Guidelines for Magrolimab
Dose
Dosing Frequency
Minimum Duration of Treatment Gap 
That Will Lead to Repriming
1 mg/kg
NA – used at initial priming
2 weeks
Weekly (during Cycles 1 and/or 2)
2 weeks
15 mg/kg
Every 3 weeks
4 weeks
Weekly (during Cycles 1 and/or 2)
2 weeks
20 mg/kg
Every 3 weeks
4 weeks
Weekly (during Cycles 1 and/or 2)
4 weeks
30 mg/kg
Every 3 weeks
4 weeks
45 mg/kg
Every 3 weeks
4 weeks
60 mg/kg
Every 3 weeks
4 weeks
NA = not applicable
If planned surgical procedures are needed for patients on study treatment, magrolimab will be 
delayed and restarted in accordance with Table 9.
Table 9.
Magrolimab Dosing Guidance for Planned Surgical Procedures on 
Study
Planned Surgical Procedure
Magrolimab Dose Guidance
Minimally invasive procedure 
(Examples: biopsies [excluding lung/liver], 
skin/subcutaneous lesion removal, 
cataract/glaucoma/eye surgery/cystoscopy)
Hold magrolimab dose 3 days prior to procedure and 
restart after 3 days

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Planned Surgical Procedure
Magrolimab Dose Guidance
Moderately invasive procedure
(Examples: lung/liver biopsy, hysterectomy, 
cholecystectomy, hip/knee replacement, minor 
laparoscopic procedures, stent/angiopathy)
Hold magrolimab dose 3 days prior to procedure and 
restart after 5 days
Highly invasive procedure
(Examples: central nervous system/spine surgery, 
major vascular surgery, cardiothoracic surgery, major 
laparoscopic surgery)
Hold magrolimab dose 3 days prior to procedure and 
restart after 7 days
5.9.2.
Magrolimab Premedication and Prophylaxis
Premedication is required prior to the administration of the first 2 doses of magrolimab and in 
case of reintroduction with repriming. Premedication during subsequent infusions may be 
continued based on the treating physician’s clinical judgment and the presence/severity of prior 
IRRs. 
Premedications should include oral acetaminophen 650 to 1000 mg, oral or IV diphenhydramine 
25 to 50 mg, and IV dexamethasone 4 to 20 mg, or a comparable regimen. Premedication 
decisions for subsequent infusions should be based on the treating physician’s clinical judgment 
and the presence/severity of prior IRRs (guidance is provided in Section 7.8.1.3 Management of 
Infusion-Related Reactions). 
5.10.
Dosage and Administration of Pembrolizumab
The pembrolizumab dosing regimen for each cohort is presented in Table 2 to Table 5.
Pembrolizumab will be administered at a dose of 200 mg using a 30-minute IV infusion. Sites 
should make every effort to ensure infusion timing is as close to 30 minutes as possible. 
However, given the variability of infusion pumps from site to site, a window between 
−10 minutes and +10 minutes is permitted.
5.10.1.
Dose Modifications for Pembrolizumab
Temporary suspension or permanent discontinuation of pembrolizumab may be required in the 
event of treatment-related toxicity. Dose reductions are not permitted. See Section 7.8.2 for 
recommendations for management of toxicities.
5.11.
Dosage and Administration of Zimberelimab
The zimberelimab dosing regimen is presented in Table 3.
Zimberelimab will be administered at a dose of 360 mg IV, using a 60 (± 15 minutes)-minute 
infusion. All patients will be monitored for 30 to 60 minutes after the end of each infusion. 
Postinfusion monitoring should begin after the zimberelimab infusion is complete and prior to 
administering subsequent study drugs. 

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5.11.1.
Dose Modifications for Zimberelimab
Temporary suspension or permanent discontinuation of zimberelimab may be required in the 
event of treatment-related toxicity. Dose reductions are not permitted. See Section 7.8.3 for 
recommendations for management of toxicities.
5.12.
Dosage and Administration of 5-Fluorouracil
The 5-FU dosing regimen for Safety Run-in 1 and Phase 2 Cohort 1 is presented in Table 2 and 
Table 3, respectively.
5-Fluorouracil will be administered as a continuous infusion from Days 1 to 4 of each treatment 
cycle. On Day 1 of each treatment cycle, the 5-FU infusion should be started after completion of 
all procedures and assessments according to the schedule of assessments (Appendix Table 1).
5.12.1.
Dose Modifications for 5-Fluorouracil
Dose modification guidelines for 5-FU for febrile neutropenia or documented infection and 
drug-related AEs are described in Table 10, Table 11, and Table 12. If 5-FU is discontinued for 
reasons other than disease progression, the remaining drug(s) in the combination regimen may be 
continued.
Table 10.
5-Fluorouracil Dose Modification Levels
Dose Level 0
Dose Level −1
Dose Level −2
Dose Level −3
5-FU
1000 mg/m2
800 mg/m2
(20% decrease)
640 mg/m2
(20% decrease)
Discontinue
5-FU = 5-fluorouracil
Table 11.
5-Fluorouracil Dose Modification Guidelines for Febrile Neutropenia 
or Documented Infection
Adverse Event
Number of Occurrences
Treatment Modification
1
Reduce by 1 dose level
The use of growth factors and antibiotics should be 
considered per local standards
2
Reduce by 1 dose level
Consider prophylactic antibiotics for subsequent cycles
The use of growth factors should be strongly considered 
per local standards
Febrile neutropeniaa
Documented infection
3
Discontinue 5-FU
5-FU = 5-fluorouracil
a
Absolute neutrophil count < 1000/mm3 (1.0  109/L) and a single temperature > 38.3 °C or sustained temperature ≥ 38 °C 
for > 1 hour.

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Table 12.
5-Fluorouracil Dose Modification Guidelines for Drug-Related 
Adverse Events
Category
Toxicity
Hold 5-FU 
Treatment 
for Grade
Timing for 
Restarting 
5-FU 
Treatmentc
Dose for 
Restarting 5-FU 
Treatment
Discontinue 5-FU
3a
Neutrophil count 
resolves to 
≥ 1000/mm3 
(1.0  109/L)
No reduction
Consider G-CSF
Toxicity does not 
resolve within 12 weeks 
of last infusion or if 
> 2 dose level 
reductions exceeded
Neutropenia
4a
Neutrophil count 
resolves to 
≥ 1000/mm3 
(1.0  109/L)
Reduce by 1 dose 
level
Consider G-CSF
Toxicity does not 
resolve within 12 weeks 
of last infusion or if 
> 2 dose level 
reductions exceeded
2
Platelet count 
resolves to 
≥ 75,000/mm3 
(75  109/L) or 
baseline
No reduction 
Toxicity does not 
resolve within 12 weeks 
of last infusion or if 
> 2 dose level 
reductions exceeded
Hematologic
Thrombocytopenia
3 or 4a
Platelet count 
resolves to 
≥ 75,000/mm3 
(75  109/L) or 
baseline
Reduce by 1 dose 
level
Toxicity does not 
resolve within 12 weeks 
of last infusion or if 
> 2 dose level 
reductions exceeded
Creatinine 
increased
2 to 4a
Toxicity resolves 
to Grade 0 or 1
No reduction
Toxicity does not 
resolve within 12 weeks 
of last infusion or if 
> 2 dose level 
reductions exceeded
Mucositis diarrhea
2 to 4a
Toxicity resolves 
to Grade 0 or 1
Reduce by 1 dose 
level
Toxicity does not 
resolve within 12 weeks 
of last infusion or if 
> 2 dose level 
reductions exceeded
2
Toxicity resolves 
to Grade 0 or 1
No reduction
Toxicity does not 
resolve within 12 weeks 
of last infusion or if 
> 2 dose level 
reductions exceeded
Hand-foot 
syndrome
3 to 4a
Toxicity resolves 
to Grade 0 or 1
Reduce by 1 dose 
level
Toxicity does not 
resolve within 12 weeks 
of last infusion or if 
> 2 dose level 
reductions exceeded
Nonhematologic
All other 
nonhematologic 
toxicitiesb
3 to 4a
Toxicity resolves 
to Grade 0 or 1
Reduce by 1 dose 
level
Toxicity does not 
resolve within 12 weeks 
of last infusion or if 
> 2 dose level 
reductions exceeded

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Category
Toxicity
Hold 5-FU 
Treatment 
for Grade
Timing for 
Restarting 
5-FU 
Treatmentc
Dose for 
Restarting 5-FU 
Treatment
Discontinue 5-FU
Laboratory AEb
4a
Toxicity resolves 
to ≤ Grade 2
Reduce by 1 dose 
level
Toxicity does not 
resolve within 12 weeks 
of last infusion or if 
> 2 dose level 
reductions exceeded
5-FU = 5-fluorouracil; AE = adverse event; G-CSF = granulocyte colony-stimulating factor
a
Permanent discontinuation should be considered for any severe or life-threatening event. Consult the sponsor before 
restarting treatment after a Grade 4 drug-related AE.
b
Patients with an intolerable or persistent Grade 2 drug-related AE may hold dosing at the physician’s discretion. 
Permanently discontinue 5-FU for persistent Grade 2 adverse reactions for which treatment has been held and that do not 
improve to Grade 0 or 1 within 12 weeks of the last dose. With investigator and sponsor agreement, patients with a 
laboratory AE still at Grade 2 after 12 weeks may continue in the study only if asymptomatic and the AE does not worsen.
c
Restarting 5-FU should occur on Day 1 of the next cycle after criteria for restarting has been met.
5.13.
Dosage and Administration of Platinum (Cisplatin or Carboplatin)
Cisplatin or carboplatin can be administered in Safety Run-in 1 and Phase 2 Cohort 1 per 
investigator choice. The platinum dosing regimen for Safety Run-in 1 and Phase 2 Cohort 1 is 
presented in Table 2 and Table 3, respectively.
Cisplatin will be administered after completion of all procedures and assessments according to 
the schedule of assessments (Appendix Table 1). Cisplatin is given using an infusion duration of 
60 minutes (or infusion duration according to local practice). Cisplatin can be administered for a 
maximum of 6 cycles. Patients receiving cisplatin may switch to carboplatin if toxicities occur 
based on investigator judgment with sponsor notification.
Carboplatin will be administered after completion of procedures and assessments according to 
the schedule of assessments (Appendix Table 1). Carboplatin is given using an infusion duration 
of 60 minutes (or infusion duration according to local practice). Carboplatin can be administered 
for a maximum of 6 cycles. Patients receiving carboplatin may switch to cisplatin if toxicities 
occur based on investigator judgment with sponsor notification.
5.13.1.
Dose Modifications for Platinum (Cisplatin or Carboplatin)
Investigators may switch patients from cisplatin to carboplatin during the study if toxicities 
occur. If the cisplatin dose was modified prior to switching, the patient may start at a carboplatin 
dose of AUC 5 and will be eligible to receive additional 2 dose modifications of carboplatin. 
Platinum dose modification guidelines for febrile neutropenia or documented infection and 
drug-related AEs are described in Table 13, Table 14, and Table 15. If platinum is discontinued 
for reasons other than disease progression, the remaining drug(s) in the combination regimen 
may be continued.

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Table 13.
Platinum Dose Modification Levels
Dose Level 0
Dose Level −1
Dose Level −2
Dose Level −3
Cisplatin
100 mg/m2
80 mg/m2
(20% decrease)
64 mg/m2
(20% decrease)
Discontinue
Carboplatin
AUC 5
AUC 4 
(20% decrease)
AUC 3
(20% decrease)
Discontinue
Table 14.
Platinum Dose Modification Guidelines for Febrile Neutropenia or 
Documented Infection
Adverse Event
Number of Occurrences
Treatment Modification
1
Reduce by 1 dose level
The use of growth factors and antibiotics should be 
considered per local standards
2
Reduce by 1 dose level
Consider prophylactic antibiotics for subsequent cycles
The use of growth factors should be strongly 
considered per local standards
Febrile neutropeniaa
Documented infection
3
Discontinue platinum
a
Absolute neutrophil count < 1000/mm3 (1.0  109/L) and a single temperature > 38.3 °C or sustained temperature ≥ 38 °C 
for > 1 hour.
Table 15.
Platinum Dose Modification Guidelines for Drug-Related Adverse 
Events
Category
Toxicity
Hold Platinum 
Treatment for 
Grade
Timing for Restarting 
Platinum Treatmentc
Dose for Restarting 
Platinum Treatment
Discontinue 
Platinum
3a
Neutrophil count 
resolves to ≥ 1000/mm3 
(1.0  109/L)
No reduction
Consider G-CSF
Toxicity does not 
resolve within 
12 weeks of last 
infusion or if 
> 2 dose level 
reductions exceeded
Neutropenia
4a
Neutrophil count 
resolves to ≥ 1000/mm3 
(1.0  109/L)
Reduce by 1 dose 
level
Consider G-CSF
Toxicity does not 
resolve within 
12 weeks of last 
infusion or if 
> 2 dose level 
reductions exceeded
2
Platelet count resolves 
to ≥ 75,000/mm3 
(75  109/L) or baseline
No reduction
Toxicity does not 
resolve within 
12 weeks of last 
infusion or if 
> 2 dose level 
reductions exceeded
Hematologic
Thrombocytopenia
3 or 4a
Platelet count resolves 
to ≥ 75,000/mm3 
(75  109/L) or baseline
Reduce by 1 dose 
level
Toxicity does not 
resolve within 
12 weeks of last 
infusion or if 
> 2 dose level 
reductions exceeded

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Category
Toxicity
Hold Platinum 
Treatment for 
Grade
Timing for Restarting 
Platinum Treatmentc
Dose for Restarting 
Platinum Treatment
Discontinue 
Platinum
Creatinine 
increased
2 to 4a
Toxicity resolves to 
Grade 0 or 1
For patients taking 
carboplatin, reduce 
by 1 dose level.
For patients taking 
cisplatin, change 
cisplatin to 
carboplatin.
Toxicity does not 
resolve within 
12 weeks of last 
infusion or if 
> 2 dose level 
reductions exceeded
2
Change cisplatin to carboplatin
May continue treatment with carboplatin
Ototoxicity or 
sensory neuropathy
3 or 4a
May switch cisplatin to carboplatin if resolves to ≤ Grade 2 within 12 
weeks of last infusion
If already using carboplatin, then discontinue
All other 
nonhematologic 
toxicitiesb
3 or 4a
Toxicity resolves to 
Grade 0 or 1
Reduce by 1 dose 
level
Toxicity does not 
resolve within 
12 weeks of last 
infusion or if 
> 2 dose level 
reductions exceeded
Nonhematologic
Laboratory AEb
4a
Toxicity resolves to 
≤ Grade 2 
Reduce by 1 dose 
level
Toxicity does not 
resolve within 
12 weeks of last 
infusion or if 
> 2 dose level 
reductions exceeded
AE = adverse event; G-CSF = granulocyte colony-stimulating factor
a
Permanent discontinuation should be considered for any severe or life-threatening event. Consult the sponsor before 
restarting treatment after a Grade 4 drug-related AE.
b
Patients with an intolerable or persistent Grade 2 drug-related AE may hold dosing at the physician’s discretion. 
Permanently discontinue platinum for persistent Grade 2 adverse reactions for which treatment has been held and that do not 
improve to Grade 0 or 1 within 12 weeks of the last dose. With investigator and sponsor agreement, patients with a 
laboratory AE still at Grade 2 after 12 weeks may continue in the study only if asymptomatic and the AE does not worsen.
c
Restarting platinum should occur on Day 1 of the next cycle after criteria for restarting has been met.
5.14.
Dosage and Administration of Docetaxel
The docetaxel dosing regimen for Safety Run-in 2 and Phase 2 Cohort 3 is presented in Table 6 
and Table 7, respectively. Docetaxel will be administered at a dose of 75 mg/m2 using a 
60-minute (± 5 minutes) IV infusion (or an infusion duration according to local practice).
5.14.1.
Dose Modifications for Docetaxel
Docetaxel is known to cause neutropenia, hepatotoxicity, peripheral neuropathy, fluid retention, 
and hypersensitivity reactions. Dose reductions per key toxicities are described below and are in 
accordance with the docetaxel prescribing information.
5.14.1.1.
Neutropenia
Docetaxel causes neutropenia; guidance on dose reductions is shown in Table 16. Patients should 
have an ANC ≥ 1500 cells/μL before initiating the next cycle of docetaxel therapy. Myeloid 
growth factor support is allowed per institutional guidelines.

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Table 16.
Docetaxel Dose Modification Guidelines for Neutropenia
Hematologic Toxicity
Occurrence
Docetaxel Dose
(mg/m2) per Cycle
First
55
Second
37.5
Neutropenic fever (nadir ANC < 500 cells/µL with fever > 38 °C) 
for > 7 days despite growth factor support
Delay of next cycle by > 14 days for nadir ANC < 1500 cells/μL
or
Nadir ANC < 500 cells/µL for > 7 days
Third
Discontinue treatment
ANC = absolute neutrophil count
5.14.1.2.
Hepatic Toxicity
Docetaxel should be withheld for Grade 3 or 4 hepatic toxicity deemed related to docetaxel as 
specified in Table 17. In addition, the investigator should make every effort to exclude malignant 
disease progression as a cause of liver enzyme derangement, which would not be considered a 
toxicity for docetaxel.
Table 17.
Docetaxel Dose Modification Guidelines for Hepatic Toxicity
Hepatic Toxicity
Occurrence
Docetaxel Dose Modification
First
Interrupt treatment until AST/ALT ≤ 1.5  ULN and 
alkaline phosphatase ≤ 2.5  ULN, then reduce to 
55 mg/m2
Interrupt treatment until bilirubin ≤ 1.25  ULN, then 
reduce to 55 mg/m2
If toxicity does not resolve to above criteria within 
3 weeks, discontinue treatment
Second
Interrupt treatment until AST/ALT ≤ 1.5  ULN and 
alkaline phosphatase ≤ 2.5  ULN, then reduce to 
37.5 mg/m2
Interrupt treatment until bilirubin ≤ 1.25  ULN, then 
reduce to 37.5 mg/m2
If toxicity does not resolve to above criteria within 
3 weeks, discontinue treatment
AST or ALT > 1.5  ULN (or baseline 
if higher) and alkaline phosphatase 
> 2.5  ULN
or
Bilirubin > 1.25  ULN
Third
Discontinue treatment
AST or ALT > 3  ULN (or baseline if 
higher)
and
Bilirubin > 2  ULN 
Any
Discontinue treatment
Bilirubin > 5  ULN 
Any
Discontinue treatment
AST or ALT > 5 to 10  ULN for 
> 2 weeks
or
AST or ALT > 10  ULN or baseline
Any
Discontinue treatment
ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal

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5.14.1.3.
Peripheral Neuropathy
Patients who develop ≥ Grade 3 peripheral neuropathy related to docetaxel should have 
docetaxel discontinued permanently.
5.14.1.4.
Other Toxicities
Docetaxel dose modifications for other Grade 3 or 4 hematologic or nonhematologic toxicities 
deemed related to docetaxel are shown in Table 18. Docetaxel should be delayed until 
improvement of the Grade 3 or 4 toxicity to at least Grade 2 or baseline.
Table 18.
Docetaxel Dose Modification Guidelines for Other Grade 3 or 4 
Toxicities
Other Toxicity
Occurrence
Docetaxel Dose (mg/m2) per 
Cycle
First
55
Second
37.5
Grade 3 or 4 nonhematologic or 
hematologic toxicitya that does not 
resolve to ≤ Grade 2 within 14 days 
Third
Discontinue treatment
a
Grade 3 or 4 nonhematologic or hematologic toxicities apply to those not described in the above dose modification sections.
5.14.2.
Docetaxel Premedication and Prophylaxis
For docetaxel treatment, all patients should be premedicated to reduce the incidence and severity 
of hypersensitivity reactions and fluid retention per their institutional standard of care or as 
follows. Such premedication may consist of oral corticosteroids such as dexamethasone 16 mg 
once per day (eg, 8 mg twice daily) for 3 days starting 1 day prior to docetaxel administration. 
For instances when a patient does not start oral corticosteroids prior to docetaxel administration, 
IV dexamethasone per institutional standard of care can be given prior to docetaxel 
administration.
5.15.
Prior and Concomitant Medications
5.15.1.
Permitted Concomitant Medications
Premedication and prophylaxis for AEs is permitted while on study treatment. Palliative, 
localized non-CNS radiotherapy to areas of nontarget disease, erythroid and/or myeloid growth 
factors (see Section 7.8.1.6), hormonal therapy, luteinizing hormone-releasing hormone agonists 
for prostate cancer, hormonal maintenance therapy for breast cancers, and treatment with 
bisphosphonates/receptor activator of nuclear factor kappa-B ligand inhibitors are permitted.
For patients receiving zimberelimab, immunosuppressive medications, including chronic 
systemic corticosteroids at supraphysiologic doses (physiologic doses being equivalent to a dose 
of ≤ 10 mg oral prednisone) 14 days before the first dose (except for patients who require 
hormone replacement therapy such as hydrocortisone) is not permitted nor while receiving study 
therapy. A temporary course of corticosteroids (ie, contrast allergy, chronic obstructive 
pulmonary disease) may be permitted, depending on the duration and dose, after discussion and 
agreement with the medical monitor. For all other patients, corticosteroid use is permitted for 
symptomatic treatment, premedication, pseudoprogression, and/or specific patient conditions. 

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Inhaled and topical corticosteroid use is permitted. The use of physiologic doses of 
corticosteroids may be approved after consultation with the sponsor. Chronic high-dose steroid 
use is not recommended.
Red blood cell and platelet transfusion are permitted during the study as clinically indicated and 
should be recorded in the electronic case report form (eCRF) dedicated to on study transfusions.
All concomitant medications, including prescription, over-the-counter, herbal supplements, and 
IV medications and fluids received within 30 days before the first dose of study treatment 
through the 30-day safety follow-up visit (or 90-day safety follow-up for zimberelimab) should 
be recorded in the eCRF. The drug name, indication, route, dose, and dates of concomitant 
medications will be captured in the eCRF.
5.15.2.
Prohibited Concomitant Medications
Anticancer therapies including chemotherapy, targeted therapies, and immunotherapy (other than 
study drugs) are not permitted while patients are on study.
Live vaccines within 30 days before the first dose of study treatment and while patients are on 
study treatment are not permitted. Radiation therapy is not permitted unless it is localized 
radiation therapy to a solitary lesion and after discussion with the sponsor.
5.16.
Timing of Dose Administration
For Safety Run-in 1 and Phase 2 Cohort 1, magrolimab should be administered prior to 
pembrolizumab or zimberelimab, followed by platinum and 5-FU. For the pre-expansion safety 
run-in for magrolimab + pembrolizumab (if applicable) and Phase 2 Cohort 2, magrolimab 
should be administered prior to pembrolizumab. Magrolimab and pembrolizumab or 
zimberelimab should be administered on the same day unless administrative reasons do not 
allow, or to accommodate the patient’s schedule, in which case pembrolizumab or zimberelimab 
may be administered on Day 2 of each cycle at the investigator’s discretion. For Safety Run-in 2 
and Phase 2 Cohort 3, magrolimab should be administered prior to docetaxel. Magrolimab 
should be administered 1 hour prior to the next IV drug delivery. Magrolimab postinfusion 
monitoring should occur as described in Section 5.9.
To accommodate the patient’s schedule, platinum chemotherapy may be administered on Day 2 
of each cycle at the investigator’s discretion.
5.17.
Accountability for Investigational Medicinal Product
The investigator is responsible for ensuring adequate accountability of all used and unused study 
drug (kits, vials, etc). This includes acknowledgment of receipt of each shipment of study drug 
(quantity and condition).
Each study site must keep accountability records that capture:
•
The date received and quantity of study drug kits (kits, vials, etc)
•
The date, patient number, and the study lot number dispensed
•
The date, quantity of used and unused study drug returned, along with the initials of the 
person recording the information

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5.17.1.
Investigational Medicinal Product 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 (SOP) 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 SOP. A copy of the site’s approved SOP 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 returned to Gilead.
If the site does not have an appropriate SOP 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
The study procedures to be conducted for each patient enrolled in the study are presented in 
tabular form in Appendix Table 1 and Appendix Table 2 and are described in the following 
sections.
The investigator must document any deviation from the protocol procedures and notify Gilead or 
the contract research organization.
6.1.
Patient Enrollment and Treatment Assignment
Entry into screening does not guarantee enrollment into the study. To manage the total study 
enrollment, Gilead, at its sole discretion, may suspend screening and/or enrollment at any site or 
study-wide at any time.
All patients in Safety Run-in 1 will receive magrolimab + pembrolizumab + platinum + 5-FU. 
Treatment assignment for patients in Phase 2 Cohort 1 will be randomized using IRT. Patients 
will be assigned to receive magrolimab + pembrolizumab + platinum + 5-FU (Arm A) or 
pembrolizumab + platinum + 5-FU (Arm B) in a 1:1 ratio. After 40 patients have been enrolled 
(20 in each arm), Arm C (magrolimab + zimberelimab + platinum + 5-FU) will open and patients 
will be randomized in a 1:1:1 ratio.
All patients in the pre-expansion safety run-in for magrolimab + pembrolizumab (if applicable) 
and Phase 2 Cohort 2 will receive magrolimab + pembrolizumab.
All patients in Safety Run-in 2 and Phase 2 Cohort 3 will receive magrolimab + docetaxel. Once 
the SRT reviews the Safety Run-in 2 and the sponsor determines the RP2D for magrolimab + 
docetaxel, Phase 2 Cohort 3 will open for enrollment.
6.2.
Pretreatment Assessments
6.2.1.
Screening Visit
Patients will be screened within 30 days before dosing on Cycle 1 Day 1 to determine eligibility 
for participation in the study. Standard-of-care procedures performed before obtaining informed 
consent may be used for screening (with the exception of the following tests shown in Table 19, 
which must be drawn after obtaining informed consent and conducted by the central laboratory: 
chemistry, hematology, coagulation, urinalysis, thyroid function, and serum pregnancy samples). 
Refer to Section 6.6 regarding use of tumor imaging obtained prior to enrollment. The following 
will be performed and documented at screening per Appendix Table 1:
•
Obtain written informed consent
•
Obtain medical history including concomitant medications
•
Obtain demographic information
•
Complete physical examination, including vital signs, body weight, and height

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•
Obtain blood and urine samples for the following tests: chemistry; hematology; coagulation; 
urinalysis; serum pregnancy; thyroid panel; blood phenotyping, type, and screen; and direct 
antiglobulin test (DAT) (Section 6.4.2). Blood for biomarker samples will also be collected 
(ie, serum and plasma, and circulating tumor DNA)
•
Tumor biopsy
•
Tumor imaging
•
ECOG
•
Perform 12-lead electrocardiogram (ECG) (single)
•
Record all serious adverse events (SAEs) related to protocol-mandated procedures occurring 
after signing of the informed consent form (ICF)
From the time of obtaining informed consent through the first administration of study drug, 
record only SAEs related to protocol-mandated procedures on the AE eCRF. All other untoward 
medical occurrences observed during the screening period, including exacerbation or changes in 
medical history, are to be considered medical history. See Section 7, Adverse Events and 
Toxicity Management, for additional details.
6.3.
Randomization
Randomization procedures are described in Section 5.1.1. Randomization must be conducted 
within 3 business days of dosing on Cycle 1 Day 1.
6.4.
Treatment Assessments
6.4.1.
Pregnancy Test
Pregnancy tests are required only for female patients of childbearing potential. Note that a 
woman is considered to be of childbearing potential following the initiation of puberty (Tanner 
Stage 2) until becoming postmenopausal, unless permanently sterile or with medically 
documented ovarian failure. Permanent sterilization includes hysterectomy, bilateral 
oophorectomy, or bilateral salpingectomy in a female patient of any age. Women are considered 
to be in a postmenopausal state when they are ≥ 54 years of age with cessation of previously 
occurring menses for ≥ 12 months without an alternative cause. In addition, women of < 54 years 
of age with amenorrhea of ≥ 12 months may also 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. A negative serum pregnancy test is 
required at screening, and a negative urine pregnancy test is required prior to study treatment 
administration on Cycle 1 Day 1. The Cycle 1 Day 1 urine pregnancy test does not need to be 
conducted if the screening pregnancy test was performed within the 3 days before study 
treatment administration. Urine pregnancy tests will also be required at Cycle 2 Day 1 and every 
cycle thereafter and continue monthly up to 6 months after the end of treatment per the duration 
of required contraception as discussed in Appendix 5.

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6.4.2.
Type and Screen and Direct Antiglobulin Test
Due to the risk of developing anemia, and because magrolimab may make phenotyping difficult 
due to expected coating of the RBC membrane, ABO (any of the 4 blood groups A, B, AB, and 
O comprising the ABO system)/rhesus (Rh) factor type, antibody screen, blood phenotyping or 
genotyping, and DAT need to be performed at screening before exposure to magrolimab. Red 
blood cell genotyping (instead of an extended RBC phenotyping) must be performed if a patient 
received any RBC or whole blood transfusion within the previous 3 months (unless the laboratory 
has availability for special techniques for performing phenotyping for patients with a recent 
transfusion). Extended RBC genotyping instead of extended RBC phenotyping is acceptable for 
any patient. Red blood cell phenotyping/genotyping, ABO type, and DAT need not be repeated if 
results dated before screening are available. Antibody screen need not be repeated if results dated 
before screening are available, unless the patient was transfused since that time. Results must be 
available before the first dose of magrolimab.
6.4.3.
Vital Signs
Vital signs will include heart rate, respiratory rate, oxygen saturation, blood pressure, 
temperature, and weight. Height will be recorded during screening only. Weight will be recorded 
during screening and on Day 1 of each cycle. Vital signs are to be recorded prior to dosing of 
study treatment at the visits specified in the schedule of assessments (Appendix Table 1).
6.4.4.
Physical Examination
Complete physical examination will be performed at screening. Thereafter, symptom-directed 
physical examinations are acceptable and may also include routine examination of the skin 
(including fingers, toes, and ears) and neurologic system.
6.4.5.
Performance Status
Performance status will be scored using the ECOG performance status scale index (refer to 
Appendix 9).
6.4.6.
Electrocardiograms
A single ECG will be performed at screening.
Refer to Appendix 12 for zimberelimab monitoring requirements in Belgium.
6.4.7.
Patient-Reported Outcomes
Three patient-reported outcomes (PROs) instruments will be administered in this study 
(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 
Core- Questionnaire [EORTC QLQ-C30], European Organisation for Research and Treatment of 
Cancer Quality of Life - Head and Neck Module [EORTC QLQ-H&N35], and 5 level EuroQol- 
5 dimensions questionnaire [EQ-5D-5L]). The patient should complete these questionnaires 
before any other study procedures at required visits, with the exception of imaging, if applicable, 
and analytes to be assessed by the local and/or central laboratory or specialty laboratories during 
the study (Table 20 Appendix 2), which may be collected prior to the visit. Please refer to the 
schedules of assessments in Appendix 2 for timing of PRO assessments. If the PRO 

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questionnaires are unavailable in a patient’s language, completion is not required. Patients with 
other barriers to questionnaire completion may be exempt from these assessments after 
discussion with the sponsor.
6.4.7.1.
EORTC QLQ-C30 and QLQ-H&N35
The EORTC QLQ-C30 is a reliable and valid measure of PROs and has been widely used among 
patients with cancer. 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. The accompanying module for head and neck 
cancer, QLQ-H&N35, has an additional 35 questions.
6.4.7.2.
EQ-5D-5L
The EQ-5D-5L is an instrument for use as a measure of health outcome {EuroQol Research 
Foundation 2017, Janssen 2013}. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive 
system and the EuroQol visual analogue scale (EQ-VAS). A sample is provided in Appendix 8.
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 be used as a quantitative measure of health outcome that reflects the patient’s 
own judgment
6.4.8.
Adverse Events
At each visit, all AEs observed by the investigator or reported by the patient that occur after the 
first dose of study treatment through 30 days after the last dose of study treatment (or 90 days 
after the last dose for zimberelimab) are to be reported using the applicable eCRF (Section 7.1.1). 
Full details on the definitions, assessment, and reporting instructions for AEs are provided in 
Section 7.
6.4.9.
Concomitant Medications
All concomitant medications taken by the patient while on study are to be documented. Changes 
in baseline concomitant medication information is to be collected after informed consent through 
the study treatment period, and up until 30 days after treatment discontinuation (or 90 days after 
discontinuation of zimberelimab). Concomitant medication associated with procedure-related 

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AEs will be captured from the time of informed consent and onward. Information to be collected 
includes drug name, indication, route, start date, and stop date and must be reported using the 
applicable eCRF. Note that any anticancer therapies after the study treatment period should also 
be collected per the schedule of assessments (Appendix Table 2).
6.5.
Safety Assessments
Analytes to be assessed by the local and/or central laboratory or specialty laboratories at 
screening are presented in Table 19. Refer to Section 7.8.1.2 for hemoglobin and hematocrit 
testing requirements for the first 2 magrolimab doses predose and postdose monitoring.
Table 19.
Screening Laboratory Analytes
Chemistry (Serum or 
Plasma)
Hematology
Urinalysisa
Other Laboratory 
Measurementsb
Sodium
Potassium
Chloride
Bicarbonatec
Total protein
Albumin
Calcium
Magnesium
Phosphorus
Glucose
BUN or urea
Creatinine
Uric acid
Total bilirubin
Direct bilirubin
Indirect bilirubin
AST (SGOT)
ALT (SGPT)
Alkaline phosphatase
RBC
Hemoglobin
Hematocrit
Platelets
WBC total
WBC differential
ANC
Eosinophils
Basophils
Lymphocytes
Monocytes
Reticulocytes
Coagulation
PT
INR
aPTT or PTT
Glucose
Protein
Urine pH
Ketones
Bilirubin
Urine specific gravity
Pregnancy (serum)
Blood phenotyping or 
genotypingd
Type and screen (ABO/Rh)d
DATd
T3 (total or free)
FT4
TSH
DPDe
Additional Samples
Tumor tissue (archival or from 
biopsy)
p16 HPVd
PD-L1d
ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; ALT = alanine aminotransferase; 
ANC = absolute neutrophil count; aPTT = activated partial thromboplastin time; AST = aspartate aminotransferase; BUN = blood 
urea nitrogen; DAT = direct antiglobulin test; DPD = dihydropyrimidine dehydrogenase; FT4 = free thyroxine; HPV = human 
papillomavirus; INR = international normalized ratio; PD-L1 = programmed cell death ligand 1; PT = prothrombin time; 
PTT = partial thromboplastin time; RBC = red blood cell; Rh = rhesus; SGOT = serum glutamic oxaloacetic transaminase; 
SGPT = serum glutamic pyruvic transaminase; T3 = triiodothyronine; TSH = thyroid-stimulating hormone; WBC = white blood 
cell
a
Reflex microscopic testing based on other abnormalities.
b
Refer to Appendix 12 for zimberelimab monitoring requirements in Belgium.
d
Test may be performed at a central laboratory or local laboratory, if available. For PD-L1 and p16 HPV, the local laboratory 
must use the protocol-specified assay.
e
Where such testing is standard of care.
Analytes are required to be collected at screening. Refer to Appendix Table 1 for collection time points.
Analytes to be assessed by the local and/or central laboratory or specialty laboratories during the 
study are presented in Table 20.
CCI

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Table 20. 
Study Laboratory Analytes (To Be Performed During the Study) 
Chemistry (Serum or Plasma) 
Sodium 
Potassium 
Chloride 
Bicarbonateb 
Total protein 
Albumin 
Calcium 
Magnesium 
Phosphoms 
Glucose 
BUN or urea 
Creatinine 
Uric acid 
Total bilimbin 
Direct bilimbin 
Indirect bilimbin 
AST (SGO1) 
ALT (SGPT) 
Alkaline phosphatase 
Haptoglobin 
LDH 
Hematology 
RBC 
Hemoglobin 
Hematocrit 
Platelets 
WBC differential 
ANC 
Eosinophils 
Basophils 
Lymphocytes 
Monocytes 
Reticulocytes 
Other Laboratory Measurements• 
Pregnancy (urine) 
Blood samples for coITelative studies 
Phannacokinetics 
Anti.chug antibodies 
T3 (total or free) 
FT4 
TSH 
Additional Samples 
Stool 
Tumor tissue from biopsy 
ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; BUN= blood urea 
nitrogen; DAT = direct antiglobulin test; FT4 = free thyroxine; LDH = lactate dehydrogenase; RBC = red blood cell; 
SGOT = serum glutam.ic oxaloacetic transaminase; SGPT = senun glutam.ic pymvic transaminase; T3 = triiodothyronine; 
TSH = thyroid-stimulating honuone; WBC = white blood cell 
. 
. 
. 
' 
' 
. 
' 
. 
Analytes are requit·ed to be collected at visits dtuing study. Refer to Appendix Table 1 for collection titue points. 
6.6. 
Efficacy Assessments 
Either computed tomography (CT), magnetic resonance imaging, or positrnn emission 
tomography-CT (that includes contrnst-enhanced CT component) of the head, neck, chest, and 
abdomen will be perfo1med at screening, eve1y 6 weeks (2 cycles) until 36 weeks (Cycle 12) and 
then eve1y 9 weeks (3 cycles) dming the study (sta1ting from Cycle 1 Day 1), and at the 
end-of-treatment visit if a response assessment has not been erfo1med within the last 30 da 
ro ·essive disease has been documented. 
Chest x-ray, 
ultrasound, endoscopy, laparoscopy, positron emission tomography, radionuclide scans, or 
tumor markers will not be considered for response assessment. 
For radiographic evaluations, the same method of assessment and the same technique 
( eg, scan type, scanner, patient position, dose of contrast, injection/scan interval) should be used 
to characterize each identified and repo1ted lesion at baseline and during study treatment and 
follow-up. 
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Scans taken as paii of standard medical practice up to 30 days prior to emollment can be used for 
screening as long as they meet all study requirements. During the ti·eatment phase, scans may be 
perfo1med at time points other than eve1y 6 or 9 weeks as clinically indicated to assess tumor 
progression. 
For patients who stop study ti·eatment in the absence of radiographic disease progression ( eg, 
experienced unexpected toxicity), scans should continue to be collected approximately eve1y 
6 weeks (2 cycles) until 36 weeks (12 cycles) from Cycle 1 Day 1 and then eve1y 9 weeks 
(3 cycles) until radiographic disease progression or initiation of systemic antitumor therapy other 
than the study u-eatment, whichever is eai·lier. 
Patients will be assessed for response by the investigator or qualified designee using RECIST, 
Version 1.1 {Eisenhauer 2009} for the primaiy and secondaiy efficacy endpoints, irRECIST 
{Nishino 2013} will be used for ti·eatment past initial detennination of disease progression by 
RECIST 1.1. 
6.7. 
Pharmacokinetic Assessments 
Magrolimab senun concenti·ation 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 ma rolimab accordin to the schedule of assessments in 
A 
endix Table 1 
Zimberelimab senun concenu-ation will be measured by a validated enzyme-linked 
irmnunosorbent assay immunoassay method. 
Blood samples for PK assessment will be collected at predose and at the end of infusion on 
Cycle 1 Day 1 and Cycle 3 Day 1 from patients who received zimberelimab according to the 
schedule of assessments in Appendix Table 1. 
6.8. 
Immunogenicity (Antidrug Antibodies) 
Peripheral blood for irmnunogenicity assessments for ADAs against magrolimab and 
zimberelimab will be collected as described in the schedule of assessments (Appendix 2). When 
collected on the day of study drng dosing, the ADA blood sample must be collected at the saine 
time as the predose PK sample. The presence of anti-magrolimab and anti-zimberelimab 
antibodies will be dete1mined by a validated chemiluminescence irmnunoassay method. 
6.9. 
Biomarker Assessments 
Biomai·ker samples will be collected to assess PD, mechanism of action, and ti·eatment response 
biomai·kers and to define conelates of clinical efficacy and/or safety, as outlined in Section 3.8. 
The biomarker sainple collection schedules are outlined in Appendix 2. 
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Patients are required to submit mandatory pretreatment tumor tissue from a core needle or 
excisional tumor biopsy (fine needle aspirate is not adequate) from a site not previously 
irradiated. A newly obtained biopsy collected within 90 days prior to study treatment start is 
strongly preferred, but an archival sample is acceptable For archival samples submitted in lieu of 
newly obtained biopsies, tissue collected within 6 months prior to study treatment start is 
strongly preferred whenever possible. 
Patients will also be requested to consent to a mandatory on-treatment biopsy, unless not feasible 
as determined by the investigator and discussed with the sponsor.
For additional details and instructions regarding tissue requirements and procedures for sample 
collection, storage, and shipment, refer to the study laboratory manual.
6.10.
Posttreatment Assessments
Posttreatment assessments are summarized in Appendix Table 2. There are 2 types of follow-up 
visit, as follows:
•
Safety follow-up (30 days [± 7 days] after the last dose of study drug, or the start of 
subsequent therapy; or 90 days [± 7 days] after the last dose of zimberelimab, or the start of 
subsequent therapy, whichever occurs first)
•
Survival follow-up (every 2 months after the safety follow-up)
Patients who discontinue study treatment are to return for an end-of-treatment visit for evaluation 
of safety within 7 days of their last dose or the decision to end study treatment. In addition, 
patients are to have a safety follow-up visit or telephone call 30 days (± 7 days) after their last 
dose of study treatment (or 90 days after the last dose of zimberelimab) or prior to the start of 
subsequent antineoplastic therapy, whichever occurs first. When an SAE or treatment-related AE 
is reported during a telephone call, the patient should come to the clinic for physical examination 
and blood tests, if clinically needed. Follow-up for ongoing SAEs or treatment-related AEs after 
the safety follow-up visit/call will stop if a patient begins another anticancer therapy. Pregnancy 
testing will continue monthly up to 6 months after the end of treatment per the duration of 
required contraception, as discussed in Appendix 5. Testing during preprogression visits and 
survival follow-up may be done at home and the result self-reported by the patient. Survival 
follow-up will be conducted via a phone call or in person, as needed, every 2 months until death 
or the end of the study. Duration of survival follow-up will be limited to 5 years.
6.11.
Assessments for Early Discontinuation From Study Treatment
If a patient discontinues study dosing (for example, as a result of an AE), every attempt should 
be made to keep the patient in the study and continue to perform the required study-related 
follow-up and procedures (Section 6.11.1). In the absence of disease progression, scans should 
continue to be collected as described in Section 6.6 until disease progression or initiation of 
systemic antitumor therapy other than the study treatment, whichever is earlier. For patients who 
discontinue from the study prior to completion of all protocol-required visits for study 
assessments or survival follow-up as described in the schedule of assessments 
(Appendix Table 2), the investigator may search publicly available records (where permitted by 
local laws and regulations) to ascertain survival status unless the patient withdraws consent for 
such follow-up. This ensures reduced risk of missing critical efficacy data.

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6.11.1. 
Criteria for Discontinuation of Study Treatment 
Criteria for discontinuation of study ti·eatment are provided in Section 3.4. 
6.12. 
Criteria for Discontinuation From Study/End of Study 
Criteria for discontinuation from study are provided in Section 3.5. 
6.13. 
Poststudy Care 
Final 
Amendment6 
Upon withdrawal from study ti·eatment, patients will receive the care upon which they and their 
physicians agree. Postti·eatment assessments are described in Appendix Table 2. See 
Appendix 12 for poststudy care considerations in France. 
6.14. 
Sample Storage 
At t e en 
O t IS SUI y, 
these samples may be retained in storage by Gilead for a period up to 15 years. If patients 
provide additional specific consent, residual PK samples may be desti·oyed no later than 15 years 
after the end of study or per country requirements. 
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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, and 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 ICF 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 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.)
•
Inpatient hospitalization or prolongation of existing hospitalization
•
Persistent or significant disability/incapacity
•
A congenital anomaly/birth defect

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•
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 Adverse Event/Serious Adverse Event Clarifications
Given that 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 NCI CTCAE Grade 5.
7.1.3.
Study Drugs and Gilead Concomitant Therapy Special Situations Reports
Special situation 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 or 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.

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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/device 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.
7.2.1.
Assessment of Causality for Study Drugs and Procedures
The investigator or qualified subinvestigator is responsible for assessing the relationship to study 
drug 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, or concomitant medication).
•
Yes: There is reasonable possibility that the event 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.
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).

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7.2.2.
Assessment of Severity
The severity of AEs will be graded using the NCI CTCAE, Version 5.0. For each episode, the 
highest grade attained should be reported as defined in the Toxicity Grading Scale (Appendix 4).
7.3.
Investigator Reporting Requirements and Instructions
7.3.1.
Requirements for Collection Prior to Study Drug Initiation
After informed consent, but prior to initiation of study medication, 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, all AEs, regardless of cause or relationship, will be collected 
until 30 days after last administration of study drug (or 90 days after the last administration of 
zimberelimab) or start of subsequent anticancer therapy, whichever occurs first and reported on 
the eCRFs as instructed.
All AEs should be followed up until resolution or until the AE is stable, if possible. Gilead may 
request that certain AEs be followed beyond the protocol-defined follow-up period.
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 posttreatment follow-up visit, 
must be reported on the applicable eCRFs and to Gilead 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 after the posttreatment follow-up visit but within 30 days of the 
last dose of study drug (or 90 days after the last dose of zimberelimab), regardless of causality, 
should also be reported.
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).

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7.3.5.
Concomitant Therapy Reports
7.3.5.1.
Gilead Concomitant Therapy Special Situations Report
Special situations involving a Gilead concomitant therapy (not considered study drug) that occur 
after the patient first consents to participate in the study (ie, signing the informed consent) and 
throughout the duration of the study, including the posttreatment follow-up visit, must be 
reported to Gilead PS utilizing the paper SSR form (Section 7.4.2.2).
7.3.5.2.
Non-Gilead Concomitant Therapy 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 due to a non-Gilead concomitant 
medication, the AE should be reported on the AE form.
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 report form. Details of the symptoms and signs, clinical 
management, and outcome will be reported, when available.
7.4.
Reporting Process for Serious Adverse Events and Special Situation 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 ICF 
signature throughout the duration of the study, including the protocol-required posttreatment 
follow-up period.

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If 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:
Gilead:
Gilead PS
or
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:
Gilead PS
or
7.4.2.2.
Reporting Process for Gilead Concomitant Medications
Special situations that involve concomitant medications manufactured by Gilead 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 to:
Gilead:
Gilead PS
or
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 due to a non-Gilead concomitant 
medication must be reported as an AE.
7.4.2.3.
Pregnancy Reporting Process
The investigator should report pregnancies in female study patients that are identified after 
initiation of study drug and throughout the study, including the protocol-required posttreatment 
follow-up period or 6 months after the last dose of latest administered study treatment, 
whichever is longer, to Gilead PS within 24 hours of becoming aware of the pregnancy using the 
pregnancy report form.
PPD
PPD
PPD
PPD
PPD
PPD

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In the zimberelimab-containing cohort only, the investigator should report pregnancies in female 
partners of male patients that are identified after initiation of study drug and throughout the study 
for 120 days after the last dose of zimberelimab 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:
Gilead PS
or
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 due to 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 the 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: 
Refer to Appendix 5 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 that may be in the form of line listings, serious adverse drug reactions, or 
suspected unexpected serious adverse reactions (SUSARs). 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 SUSARs 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.
PPD
PPD
PPD

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All investigators will receive a safety letter notifying them of relevant SUSAR reports associated 
with any study drug. The investigator should notify the IRB or IEC of SUSAR 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 AEs, 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 AEs or SAEs 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 (eg, decreased 
hemoglobin).
Severity should be recorded and graded according to the NCI CTCAE, Version 5.0. 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.
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 injury, the 
patient may be discontinued from the study treatment if the investigator determines 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 injury according to Hy’s Law, defined by FDA Guidance for 
Industry, Drug-Induced Liver Injury: Premarketing Clinical Evaluation, as {U.S. Department of 
Health and Human Services 2009}:
•
Treatment-emergent ALT or AST elevation (≥ 3  ULN), AND
•
Treatment-emergent total bilirubin elevation (> 2  ULN) and absence of cholestasis 
(defined as alkaline phosphatase < 2  ULN), AND
•
No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, 
alcohol ingestion, congestive heart failure, worsening liver metastases)

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7.8.
Toxicity Management
7.8.1.
Magrolimab
7.8.1.1.
Type and Screen and Direct Antiglobulin Test
Magrolimab may interfere with RBC phenotyping due to expected coating of the RBC 
membrane. Due to the risk of developing anemia, and because magrolimab may make 
phenotyping difficult, at screening and prior to exposure to magrolimab, ABO/Rh type, antibody 
screen, DAT, and extended RBC phenotyping (including minor antigens such as CcDEe, Cw, 
MNSs, Kk, FyaFyb, and JkaJkb) will be performed for each patient (Section 6.4.2).
Red blood cell phenotyping/genotyping, ABO type and DAT need not be repeated if results 
dated before screening are available. Antibody screen need not be repeated if results dated before 
screening are available, unless the patient was transfused since that time.
7.8.1.2.
Anemia, Blood Cross-Matching, and Packed Red Blood Cell Transfusion 
Procedures
Magrolimab binds to RBCs and leads to erythrophagocytosis. CD47 is a member of the Rh 
complex in the RBCs membrane. Therefore, when magrolimab binds to CD47, it is likely to 
interfere with routine blood bank tests needed in case of transfusion. Notify blood transfusion 
centers/blood banks of this interference with blood bank testing and inform them that a patient 
will receive magrolimab. 
In clinical studies, anemia is the most common treatment-related AE and is typically manifested 
as a decline in hemoglobin of about 0.5 g/dL to 1.5 g/dL observed in the first 1 to 2 weeks of 
treatment. Significant drops in hemoglobin level (2 g/dL or higher) have also been observed in 
early doses. For patients with significant diseases or medical conditions, such as unstable angina, 
ischemic heart disease, or uncontrolled diabetes mellitus, treatment-related anemia could be 
life-threatening or fatal. Patients with a low baseline hemoglobin level, especially those with 
cardiac history or risk factors, must be monitored closely after initial administrations of 
magrolimab as preexisting anemia could be exacerbated. Red blood cell transfusions are 
permitted prior to study treatment to ensure adequate hemoglobin level as per investigator 
clinical judgment.
Within 24 hours prior to each of the first 2 doses of magrolimab infusion during initial treatment, 
all patients must have a documented hemoglobin ≥ 9 g/dL. Patients who do not meet these 
criteria must be transfused and have their hemoglobin rechecked to meet 9 g/dL prior to each of 
the first 2 doses of magrolimab.
Additional hemoglobin and hematocrit measurements must be checked 3 to 6 hours after the 
initiation of the first and second doses of magrolimab during initial treatment. Local and central 
sample collection is required. The patient should be transfused as clinically appropriate. 
Investigators should consider additional hemoglobin and hematocrit monitoring during the first 
week of treatment in patients with symptoms of anemia or at increased risk for complications of 
anemia.

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For Patients After Exposure to Magrolimab:
For all elective RBC and platelet transfusions, use leukocyte-reduced and gamma-irradiated units 
per institutional guidelines. For RBCs, phenotype/genotype matched units are preferred; 
however, cytomegalovirus (CMV)-seronegative units for CMV-seronegative patients are not 
required for this study.
For instances where the ABO/Rh type cannot be resolved, use pretreatment (historical) 
phenotype/genotype matched units for minor RBC antigens (CcDEe and Kk, to the extent 
feasible). Regarding the ABO type, the institution may use the historical blood group or O type, 
as per the institutional guidelines.
For emergency transfusions, the transfusion centers may consider using emergency Group O red 
cells if phenotype/genotype matched units are not available.
Whenever possible, blood plasma therapy should be blood type specific. Platelets should be 
blood type compatible whenever possible and, if not, should have been tested and found not to 
have high titer anti-A or anti-B. Otherwise, plasma and platelet products can be provided as per 
the institutional policy.
A recent report has suggested that cross-match interference by RBCs due to treatment with 
magrolimab may be resolved using gamma-clone anti-IgG and multiple alloadsorptions with 
papain-treated RBC samples cells, or pooled single donor apheresis platelets, or commercial 
human platelet concentrate product if required {Troughton 2018, Velliquette 2019}.
7.8.1.3.
Management of Infusion-Related Reactions
Infusion-related reactions are defined by the NCI CTCAE, Version 5.0 as “a disorder 
characterized by adverse reaction to the infusion of pharmacological or biological substances” 
(Appendix 4). For the purposes of this study, the time frame for IRR assessment is the 24-hour 
period beginning at the start of the infusion. Premedications as described in Section 5.9.2 will be 
used to proactively manage IRRs.

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Recommendations for the management of IRRs are provided in Table 21.
Table 21.
Management of Infusion-Related Reactions 
Infusion-Related Reactions
CTCAE Grade 
Management
Grade 1
Mild transient reaction
Remain at bedside and monitor patient until resolution of symptoms.
Patients who experience IRRs with the first 2 doses of magrolimab should 
continue premedication with corticosteroids prior to subsequent doses at the 
investigator’s discretion.
Grade 2
Requiring symptomatic treatment 
and prophylactic medications for 
≤ 24 hours
Interrupt magrolimab/placebo therapy per protocol and begin an IV infusion 
of normal saline and consider treating the patient with diphenhydramine 
50 mg IV (or equivalent) and/or 500 to 750 mg of oral acetaminophen.
Remain at bedside and monitor patient until resolution of symptoms.
Corticosteroid therapy may also be given at the discretion of the investigator.
If the infusion is interrupted, wait until symptoms resolve, then restart the 
infusion at 50% of the original infusion rate.
If no further complications occur after 1 hour (± 10 minutes), the rate may be 
increased to 100% of the original infusion rate. Monitor the patient closely.
If symptoms recur, stop infusion and disconnect patient from the infusion 
apparatus. No further magrolimab/placebo will be administered at that visit.
Patients who experience IRRs with the first 2 doses of magrolimab should 
continue premedication with corticosteroids prior to subsequent doses at the 
investigator’s discretion.
The amount of magrolimab infused must be recorded on the eCRF.
Patients who experience a Grade 2 IRR during the postinfusion observation 
period that does not resolve to ≤ Grade 1 during that time should be observed 
until the AE resolves or stabilizes, with vital sign measurements as medically 
indicated for the management of the AE.
Grade 3-4
Grade 3: Prolonged reactions or 
recurrence of symptoms 
following initial improvement, or 
where hospitalization is indicated 
for other clinical sequelae
Grade 4: Life-threatening 
consequences, where urgent 
intervention is indicated
Immediately discontinue infusion of magrolimab/placebo.
Begin an IV infusion of normal saline and consider treating the patient as 
follows: Administer bronchodilators, epinephrine 0.2 to 1 mg of a 1:1000 
solution for SC administration or 0.1 to 0.25 mg of a 1:10,000 solution 
injected slowly for IV administration and/or diphenhydramine 50 mg IV with 
methylprednisolone 100 mg IV (or equivalent), as needed.
All patients with ≥ Grade 3 IRRs will be observed until the AE resolves or 
stabilizes, with vital sign measurements and additional evaluations as 
medically indicated for the management of the AEs. The patient should be 
monitored until the investigator is comfortable that the symptoms will not 
recur.
Patients who experience Grade 3 IRRs must be given premedication prior to 
subsequent doses. In this setting, premedication with oral acetaminophen 
(650 to 1000 mg), oral or IV diphenhydramine (25 to 50 mg), and IV 
dexamethasone (4 to 20 mg), or a comparable regimen, is recommended for 
the subsequent 2 doses. Continued premedication with corticosteroids 
beyond these 2 doses may be administered at the discretion of the treating 
physician. 
Patients who receive premedication and still experience a recurrent Grade 3 
IRR or patients who experience a Grade 4 IRR at any time will be 
permanently discontinued from the study treatment.
For anaphylaxis, investigators should follow their institutional guidelines for 
treatment.

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Infusion-Related Reactions
CTCAE Grade 
Management
All patients with a Grade 3 or higher IRR will be observed until the AE 
resolves or stabilizes, with vital sign measurements and additional 
evaluations as medically indicated for the management of the AE.
AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; eCRF = electronic case report form; 
IRR = infusion-related reaction; IV = intravenous; SC = subcutaneous
7.8.1.4.
Management of Pneumonitis
Pneumonitis has been infrequently observed in patients receiving magrolimab. Generally, 
immune-related AEs have not been observed in clinical use with magrolimab. In contrast to 
T-cell checkpoint inhibitors, magrolimab primarily exerts its antitumor efficacy through 
macrophage-mediated phagocytosis of tumor cells. Nonspecific T-cell or other host immune 
responses that are seen with T-cell checkpoint inhibitors have not been observed with 
magrolimab in nonclinical studies. Additionally, no events of macrophage activation syndrome 
or hemophagocytic lymphohistiocytosis have been reported in clinical studies.
In instances of suspected pneumonitis, first rule out noninflammatory causes (eg, infections). If a 
noninflammatory cause is identified, treat accordingly and continue therapy per protocol. 
Evaluate with imaging (eg, chest x-ray, CT) and pulmonary consultation.
Management of potential pneumonitis is detailed in Table 22 and follows American Society of 
Clinical Oncology guidelines for immune-related AEs {Brahmer 2018}. Patients who experience 
Grade 3 or 4 pneumonitis will be permanently discontinued from study treatment.

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Table 22.
Pneumonitis Management Algorithm
CTCAE Grade of Pneumonitis
Management
Follow-Up
Grade 1
Radiographic changes 
(chest x-ray or CT) only
Monitor for signs and symptoms 
weekly and consider monitoring with 
chest x-ray
Consider pulmonary and infectious 
disease consults
Consider reimaging with CT in 
3 to 4 weeks as clinically indicated
May resume magrolimab with 
radiographic evidence of 
improvement or resolution
If no clinical improvement or 
worsening, treat as Grade 2
Grade 2
Mild-to-moderate new symptoms
Interrupt magrolimab therapy per 
protocol
Pulmonary and infectious disease 
consults
Consider empirical antibiotics
Monitor signs and symptoms every 
2 to 3 days; consider hospitalization
1 mg/kg/day oral prednisone or IV 
equivalent
Consider bronchoscopy, lung biopsy
Reimage every 1 to 3 days
If improving to baseline, taper 
corticosteroids over 4 to 6 weeks and 
resume magrolimab therapy per 
protocol
If no clinical improvement after 
48 to 72 hours or worsening, treat as 
Grade 3 to 4
Grade 3 or 4
Severe new symptoms; 
new/worsening hypoxia; 
life-threatening
Discontinue magrolimab therapy
Hospitalize
Pulmonary and infectious disease 
consults
1 to 2 mg/kg/day 
methylprednisolone IV or IV 
equivalent
Add empirical antibiotics and 
consider prophylactic antibiotics for 
opportunistic infections
Consider bronchoscopy, lung biopsy
If improving to baseline, taper 
corticosteroids over 4 to 6 weeks
If no clinical improvement after 
48 hours or worsening, consider 
additional immunosuppression 
(eg, infliximab, cyclophosphamide, 
IV immunoglobulin, mycophenolate 
mofetil)
CT = computed tomography; CTCAE = Common Terminology Criteria for Adverse Events; IV = intravenous
7.8.1.5.
Thromboembolic Events
Thromboembolic events, including deep vein thromboses and pulmonary embolisms, have been 
reported in some patients receiving magrolimab, sometimes early in therapy. Available data for 
magrolimab do not support a clear or consistent relationship between clinical thromboembolic 
events and magrolimab use. Patients should be closely monitored for the symptoms of 
thromboembolic events and treated accordingly.
7.8.1.6.
Severe Neutropenia
Severe neutropenia and febrile neutropenia have been reported in patients treated with 
magrolimab. Close monitoring of hematologic parameters (Table 20) including neutrophils is 
required for all patients treated with magrolimab. Prophylactic antibiotics and/or antimycotics 
should be considered. Administer G-CSF if clinically indicated. 

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Recommendations for magrolimab dose delay in case of severe neutropenia: 
•
For Grade 3 neutropenia (ANC ≥ 500 cells/µL) without fever or infection, delay of 
magrolimab dosing is not recommended.
•
For Grade 4 neutropenia (ANC < 500 cells/µL) without fever or infection, or Grade 3 or 
higher neutropenia with fever or infection, magrolimab dose delay should be considered. 
Upon resolution to Grade ≤ 2, resuming magrolimab at the same dose should be considered.
•
For persistent severe neutropenia or febrile neutropenia (> 2 occurrences), discontinuation of 
magrolimab can be considered.
7.8.1.7.
Serious Infections
Patients (with or without neutropenia) should be regularly monitored for signs and symptoms of 
infection. For patients with prolonged neutropenia or patients at risk, consider infection 
prophylaxis including antibiotics (eg, fluoroquinolone) or antifungal agents (eg, oral triazoles or 
parenteral echinocandin) in accordance with current guidelines. For serious infections, hold 
magrolimab until the infection has resolved clinically. For serious infections that remain active 
for 14 or more days, consider discontinuation of magrolimab.
7.8.2.
Pembrolizumab
Dose modifications for pembrolizumab are described in Section 5.10.1.
Adverse events associated with pembrolizumab exposure may represent an immune-based 
etiology. These immune-related AEs may occur shortly after the first dose or several months 
after the last dose of pembrolizumab treatment and may affect more than 1 body system 
simultaneously. Therefore, early recognition and initiation of treatment are critical to reduce 
complications. Based on existing clinical study data, most immune-related AEs were reversible 
and could be managed with interruptions of pembrolizumab, administration of corticosteroids, 
and/or other supportive care. For suspected immune-related AEs, ensure adequate evaluation to 
confirm etiology or exclude other causes. Additional procedures or tests such as bronchoscopy, 
endoscopy, and skin biopsy may be included as part of the evaluation. Based on the severity of 
immune-related AEs, withhold or permanently discontinue pembrolizumab and administer 
corticosteroids. Dose modification and toxicity management guidelines for immune-related AEs 
associated with pembrolizumab are provided in Table 23. If pembrolizumab is discontinued for 
reasons other than disease progression, the remaining drug(s) in the combination regimen may be 
continued. Additional safety guidelines are provided in the country-specific prescribing 
information.

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Table 23.
Pembrolizumab Dose Modification and Toxicity Management 
Guidelines
Immune-
Related AE
Toxicity Grade 
or Conditions 
(CTCAE 
Version 5.0)
Action Taken 
With 
Pembrolizumab
Immune-Related AE 
Management With 
Corticosteroid and/or 
Other Therapies
Monitor and Follow-Up
Grade 2
Withhold
Pneumonitis
Grade 3 or 4 or 
recurrent Grade 2
Permanently 
discontinue
• Administer 
corticosteroids (initial 
dose of prednisone 
1-2 mg/kg or equivalent) 
followed by taper
• Monitor patients for signs and 
symptoms of pneumonitis
• Evaluate patients with 
suspected pneumonitis with 
radiographic imaging and 
initiate corticosteroid 
treatment
• Add prophylactic antibiotics 
for opportunistic infections
Grade 2 or 3
Withhold
Diarrhea/colitis
Grade 4
Permanently 
discontinue
• Administer 
corticosteroids (initial 
dose of prednisone 
1-2 mg/kg or equivalent) 
followed by taper
• Monitor patients for signs and 
symptoms of enterocolitis (ie, 
diarrhea, abdominal pain, 
blood or mucus in stool with 
or without fever) and of bowel 
perforation (ie, peritoneal 
signs and ileus)
• Patients with ≥ Grade 2 
diarrhea suspecting colitis 
should consider GI 
consultation and performing 
endoscopy to rule out colitis
• Patients with diarrhea/colitis 
should be advised to drink 
liberal quantities of clear 
fluids. If sufficient oral fluid 
intake is not feasible, fluid and 
electrolytes should be 
substituted via IV infusion
Grade 2
Withhold
• Administer 
corticosteroids (initial 
dose of prednisone 
0.5-1 mg/kg or 
equivalent) followed by 
taper
AST/ALT 
elevation or 
increased 
bilirubin
Grade 3 or 4
Permanently 
discontinue
• Administer 
corticosteroids (initial 
dose of prednisone 
1-2 mg/kg or equivalent) 
followed by taper
• Monitor with liver function 
tests (consider weekly or more 
frequently until liver enzyme 
value returned to baseline or is 
stable)
T1DM or 
hyperglycemia
Newly onset T1DM 
or Grade 3 or 4 
hyperglycemia 
associated with 
evidence of β-cell 
failure
Withhold
• Initiate insulin 
replacement therapy for 
patients with T1DM
• Administer 
antihyperglycemic in 
patients with 
hyperglycemia
• Monitor patients for 
hyperglycemia or other signs 
and symptoms of diabetes

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Immune-
Related AE
Toxicity Grade 
or Conditions 
(CTCAE 
Version 5.0)
Action Taken 
With 
Pembrolizumab
Immune-Related AE 
Management With 
Corticosteroid and/or 
Other Therapies
Monitor and Follow-Up
Grade 2
Withhold
Hypophysitis
Grade 3 or 4
Withhold or 
permanently 
discontinuea
• Administer 
corticosteroids and 
initiate hormonal 
replacements as 
clinically indicated
• Monitor for signs and 
symptoms of hypophysitis 
(including hypopituitarism and 
adrenal insufficiency)
Grade 2
Continue
Hyperthyroidism
Grade 3 or 4
Withhold or 
permanently 
discontinuea
• Treat with nonselective 
beta-blockers 
(eg, propranolol) or 
thionamides as 
appropriate
• Monitor for signs and 
symptoms of thyroid disorders
Hypothyroidism
Grades 2-4
Continue
• Initiate thyroid 
replacement hormones 
(eg, levothyroxine or 
liothyronine) per 
standard of care
• Monitor for signs and 
symptoms of thyroid disorders
Grade 2
Withhold
Nephritis and 
renal dysfunction
Grade 3 or 4
Permanently 
discontinue
• Administer 
corticosteroids 
(prednisone 1-2 mg/kg 
or equivalent) followed 
by taper
• Monitor changes of renal 
function
Grade 1 or 2
Withhold
Myocarditis
Grade 3 or 4
Permanently 
discontinue
• Based on severity of AE, 
administer 
corticosteroids
• Ensure adequate evaluation to 
confirm etiology and/or 
exclude other causes
Intolerable/persistent 
Grade 2
Withhold
Grade 3
Withhold or 
discontinue based on 
the type of event. 
Events that require 
discontinuation 
include, and are not 
limited to, GBS and 
encephalitis
All other 
immune-related 
AEs
Grade 4 or recurrent 
Grade 3
Permanently 
discontinue
• Based on type and 
severity of AE, 
administer 
corticosteroids
• Ensure adequate evaluation to 
confirm etiology and/or 
exclude other causes
AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology 
Criteria for Adverse Events; GBS = Guillain-Barre Syndrome; GI = gastrointestinal; IV = intravenous; T1DM = type 1 diabetes 
mellitus
a
The decision to withhold or permanently discontinue pembrolizumab is at the discretion of the investigator or treating 
physician.
For patients with Grade 3 or 4 immune-related endocrinopathy for which withholding of 
pembrolizumab is required, pembrolizumab may be resumed when the AE resolves to ≤ Grade 2 
and is controlled with hormonal replacement therapy or achieves metabolic control (in the case 
of type 1 diabetes mellitus [T1DM]).

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7.8.3.
Zimberelimab
Zimberelimab management guidelines are provided in Table 24, which is intended to provide 
guidance on how to manage zimberelimab (eg, continue treatment, hold treatment, resume 
treatment, permanently discontinue) for a given toxicity. Monitor patients closely for signs and 
symptoms of immune-related AEs. Early evaluations with radiographic imaging, relevant 
laboratory testing, procedures and specialty consultation should be considered. Management of 
toxicities should be conducted in accordance with best clinical practices, standard institutional 
guidelines, and current European Society for Medical Oncology (ESMO), American Society of 
Clinical Oncology (ASCO), and/or National Comprehensive Cancer Network (NCCN) 
guidelines. The study medical monitor may be contacted if there are differences between these 
toxicity management guidelines and local guidelines and/or institutional standard practice. 
Additional country-specific requirements for monitoring of zimberelimab toxicity are presented 
in Appendix 12 (patients in Belgium only).
All toxicities will be graded according to NCI CTCAE Version 5.0. In case of doubt, the 
investigator should consult with the medical monitor.
Zimberelimab treatment may be temporarily suspended in patients experiencing toxicity 
considered to be related to study treatment. If zimberelimab has been withheld for more than 
42 days because of toxicity, the patient should be discontinued from zimberelimab. However, 
zimberelimab can be resumed after being withheld for more than 42 days if the medical monitor 
agrees that the patient is likely to derive clinical benefit.
Table 24.
Treatment Modifications and Toxicity Management for 
Zimberelimab
Adverse Event
Severity
Action to be Taken With Zimberelimab
Grade 1-2
• Interrupt infusion
• If symptoms resolve with supportive care 
promptly consider resuming infusion
Infusion-related reaction
(including anaphylaxis)
Grade 3-4 
(including anaphylaxis)
• Stop infusion and permanently discontinue
Grade 1
• Continue at investigator discretion
Grade 2-3
• Consider holding
• If treatment is held, resume when improved to 
Grade 1 or baseline
Dermatologic toxicity 
(including but not limited to 
rash, maculopapular rash, and 
pruritis)
For SJS and TEN, see specific 
recommendations
Grade 4 
• Permanently discontinue
SCAR (including but not 
limited to SJS or TEN)
Any
• Permanently discontinue
Myocarditis
Grade 2-4
• Permanently discontinue
CCI

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Adverse Event
Severity
Action to be Taken With Zimberelimab
Grade 2
• Withhold
• If held, resume after ALT/AST returns to 
baseline
Hepatitis/transaminitis without 
elevated bilirubin
Grade 3 or 4
• Permanently discontinue
Grade 1 or 2 blood 
bilirubin increased
• Withhold
• Discontinue any potentially hepatotoxic 
medications. If no resolution, then permanently 
discontinue
Hepatitis/transaminitis with 
elevated bilirubin (except in 
Gilbert’s syndrome)
Grade ≥ 3 blood 
bilirubin increased
• Permanently discontinue
Grade 1 or 2
• Consider holding
Endocrinopathies
(adrenal, pituitary, diabetes)
Grade 3 or 4
• Hold until clinical management is stable
• Resume when improved to Grade ≤ 1
Thyroid disorder 
(hypothyroidism and 
hyperthyroidism)
• No discontinuation required for hypothyroidism
• For symptomatic hyperthyroidism resembling Graves-like disease, consider 
holding and resuming after workup is complete and there is evidence of 
improvement in symptoms and TFTs
Grade 2
• Hold
• Resume when improved to ≤ Grade 1 and 
steroids are tapered to ≤ 10 mg/day or 
discontinued
Nephritis or immune-mediated 
kidney injury
Grade 3 or 4
• Permanently discontinue if related to treatment
Grade 2 or 3
• Hold
• Resume when colitis/diarrhea resolves to Grade 
≤ 1 and steroid dose is stable/decreasing at 
≤ 10 mg/day (prednisone or equivalent dose)
• Discontinue if recurrence on rechallenge
Diarrhea/colitis including 
immune-mediated colitis/
enterocolitis
Grade 4
• Permanently discontinue
Grade 1
• Monitor closely if continuing
Grade 2
• Hold
• Consider resuming when improved to Grade ≤ 1 
and steroid dose is stable/decreasing at 
≤ 10 mg/day (prednisone or equivalent dose)
Pneumonitis, including 
immune-mediated lung 
disease and interstitial lung 
disease
Grade 3 or 4 
pneumonitis
• Permanently discontinue

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Adverse Event
Severity
Action to be Taken With Zimberelimab
Grade 2
• Consider holding
• Resume when:
o Symptoms no longer present
oNo radiographic evidence of pancreatic 
inflammation
oAmylase and lipase have returned to 
normal or baseline
Pancreatitis
Grade 3 or 4
• Permanently discontinue
Grade 2
• Consider holding
• If held, resume when improved to ≤ Grade 1
Grade 3 
• Hold
• Consider resuming when improved to ≤ Grade 1
Other 
(may involve any organ 
system)
Grade 3 (recurrent) or 
Grade 4
• Permanently discontinue
ALT = alanine aminotransferase; AST = aspartate aminotransferase; SCAR = severe cutaneous adverse reaction; SJS = 
Stevens-Johnson syndrome; TEN = toxic epidermal necrolysis; TFTs = thyroid function tests
7.8.4.
5-Fluorouracil
Safety management guidelines for 5-FU are described in Section 5.12.1. Additional safety 
guidelines are provided in the country-specific prescribing information.
7.8.5.
Cisplatin
Safety management guidelines for cisplatin are described in Section 5.13.1. Additional safety 
guidelines are provided in the country-specific prescribing information.
7.8.6.
Carboplatin
Safety management guidelines for carboplatin are described in Section 5.13.1. Additional safety 
guidelines are provided in the country-specific prescribing information.
7.8.7.
Docetaxel
Safety management guidelines for docetaxel are described in Section 5.14. Additional safety 
guidelines are provided in the country-specific prescribing information.

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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
The objectives and endpoints are provided in Section 2.
8.2.
Planned Analyses
8.2.1.
Safety Analysis
8.2.1.1.
Dose Determination Analysis
For the purposes of making the dose de-escalation decisions for the safety run-in evaluations, 
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 1 dosing cycle (21 days), as 
defined in Section 3.1.1.
8.2.2.
Efficacy Analysis
For the primary analysis of each cohort, outstanding data queries will have been resolved or 
adjudicated as unresolvable, and the data will have been cleaned and finalized for the analysis.
8.2.2.1.
Phase 2 Cohort 1
For Phase 2 Cohort 1, the primary analysis of PFS will be conducted after 93 PFS events occur 
in Arm A and Arm B.
8.2.2.2.
Phase 2 Cohorts 2 and 3
For Phase 2 Cohorts 2 and 3, the primary analysis of ORR will be conducted 6 months after the 
last patient is enrolled.
8.2.3.
Final Analysis
The final analysis will be performed 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.
8.3.
Analysis Conventions
8.3.1.
Analysis Sets
8.3.1.1.
Efficacy
8.3.1.1.1.
Safety Run-in
For the Safety Run-in evaluations, the primary analysis set for efficacy analysis is the Modified 
Intent-to-Treat (mITT) Analysis Set, defined as all patients who received at least 1 dose of any 
study drug.

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8.3.1.1.2.
Phase 2 Cohort 1
For Phase 2 Cohort 1, the primary analysis set for efficacy analysis is the Intent-to-Treat (ITT) 
Analysis Set, defined as concurrent randomized patients according to the treatment group to 
which the patients are randomized, unless otherwise specified.
8.3.1.1.3.
Phase 2 Cohorts 2 and 3
For Phase 2 Cohorts 2 and 3, the primary analysis set for efficacy analysis is the mITT Analysis 
Set, defined as all patients who receive at least 1 dose of study drug.
8.3.1.2.
Safety
8.3.1.2.1.
Safety Run-in
For the safety run-in evaluations, the primary analysis set for the DLT analysis is the 
DLT-Evaluable Analysis Set, which will include all enrolled patients who meet either of the 
following criteria during the DLT assessment period:
•
The patient experiences a DLT at any time after initiation of the first infusion of magrolimab.
•
The patient does not experience a DLT and completes at least 2 infusions of magrolimab and 
at least 1 dose of pembrolizumab, 1 dose of platinum, and 1 dose of 5-FU for Safety 
Run-in 1; at least 1 dose of docetaxel for Safety Run-in 2; and at least 1 dose of 
pembrolizumab for the pre-expansion safety run-in for magrolimab + pembrolizumab (if 
applicable).
For the safety run-in evaluations, the primary analysis set for safety analyses other than the DLT 
analysis is the Safety Analysis Set, defined as all patients who receive at least 1 dose of study 
drug.
8.3.1.2.2.
Phase 2 Cohort 1
For Phase 2 Cohort 1, the analysis set for safety analyses is the Safety Analysis Set, defined as 
all randomized patients who receive at least 1 dose of any study drug, with treatment assignment 
designated according to the actual treatment received.
8.3.1.2.3.
Phase 2 Cohorts 2 and 3
For Phase 2 Cohorts 2 and 3, the analysis set for safety analyses is the Safety Analysis Set, 
defined as all patients who receive at least 1 dose of any study drug.
8.3.1.3.
Pharmacokinetics
The PK analysis for magrolimab will be conducted on the Magrolimab PK Analysis Set, defined 
as all patients who receive any amount of magrolimab and have at least 1 measurable 
posttreatment serum concentration of magrolimab.

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The PK analysis for zimberelimab may be conducted on the Zimberelimab PK Analysis Set 
when appropriate, defined as all patients who receive any amount of zimberelimab and have at 
least 1 measurable posttreatment serum concentration of zimberelimab.
8.3.1.4.
Immunogenicity
The immunogenicity analysis for magrolimab will be conducted on the Magrolimab 
Immunogenicity Analysis Set, defined as all patients who receive any amount of magrolimab and 
have at least 1 evaluable anti-magrolimab antibody test result.
The immunogenicity analysis for zimberelimab may be conducted on the Zimberelimab 
Immunogenicity Analysis Set when appropriate, defined as all patients who receive any amount 
of zimberelimab and have at least 1 evaluable anti-zimberelimab antibody test result.
8.3.1.5.
Biomarker
The biomarker analysis will be conducted on the Biomarker Analysis Set, defined as all patients 
who receive any study drug and have at least 1 evaluable biomarker measurement available.
8.3.2.
Data Handling Conventions
By-patient listings will be created for important variables from each eCRF module. Summary 
tables for continuous variables will contain the following statistics: N (number in analysis set), 
n (number with data), mean, SD, and 95% CIs for the mean, median, minimum, and maximum. 
Summary tables for categorical variables will include the following statistics: N, n, percentage, 
and 95% CIs for the percentage. Unless otherwise indicated, 95% CIs for binary variables will be 
calculated using the binomial distribution (exact method) and will be 2-sided. Data will be 
described and summarized by treatment group and cohort.
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. For patients who were not dosed, unless otherwise 
specified, the baseline value will be the last (most recent) value before or on the randomization 
date (Phase 2 Cohort 1) or enrollment date (Safety Run-in cohorts and Phase 2 Cohorts 2 and 3). 
As appropriate, changes from baseline to each subsequent time point will be described and 
summarized. Graphical techniques (ie, waterfall plots, Kaplan-Meier [KM] curves, line plots) 
may be used when such methods are appropriate and informative. Analyses will be based upon 
the observed data unless methods for handling missing data are specified. If there is a significant 
degree of nonnormality, analyses may be performed on log-transformed data or nonparametric 
tests may be applied, as appropriate.
8.4.
Demographic and Baseline Characteristics Analysis
Demographic and baseline measurements will be summarized using standard descriptive 
methods. Demographic summaries will include sex, race/ethnicity, and age. Baseline data will 
include a summary of body weight, height, body mass index, selected laboratory data, medical 
and cancer history, prior treatment and number of prior treatments, tumor imaging for baseline 
response assessment, ECOG performance status, and randomization stratification factors 
(ie, PD-L1 expression and p16 status), if applicable.

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8.5.
Efficacy Analysis
8.5.1.
Primary Efficacy Endpoint Analyses
8.5.1.1.
Phase 2 Cohort 1
For Phase 2 Cohort 1, PFS will be analyzed using KM methods. Patients who do 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 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 HR and its 2-sided 
95% CI.
8.5.1.2.
Phase 2 Cohorts 2 and 3
For Phase 2 Cohorts 2 and 3, the ORR along with the 95% CI based on the Clopper-Pearson 
method will be estimated. Patients who do not have sufficient baseline or on-study tumor 
assessment to characterize response will be counted as nonresponders.
8.5.2.
Secondary Efficacy Endpoint Analyses
For Phase 2 Cohort 1, analyses of OS and PFS as secondary efficacy endpoints will be similar to 
that of the primary efficacy endpoint of PFS. For the analysis of ORR as the secondary efficacy 
endpoint, the ORR along with the 95% CI will be estimated based on the Clopper-Pearson 
method for each treatment group. The Cochran Mantel-Haenszel test adjusted for stratification 
factors will be used to compare treatment difference in ORR.
For Phase 2 Cohorts 2 and 3, analysis of ORR as the secondary efficacy endpoint will be similar 
to that of the primary efficacy endpoint of ORR. The OS and PFS as secondary efficacy 
endpoints will be analyzed using KM methods. The KM estimate of the median duration, its 
corresponding 95% CI, and the KM plots will be provided, when appropriate.
For analyses of DOR, the KM method will be used to estimate the median duration and its 
corresponding 95% CI, and the KM plots will be provided, when appropriate.
8.6.
Safety Analysis
8.6.1.
Primary Safety Endpoint Analysis
For the safety run-in evaluations, the incidence of DLTs during the DLT assessment period by 
count and percentage will be reported for each safety run-in using the DLT-Evaluable Analysis 
Set. The DLT assessment period is defined as the first cycle (21 days) and applies to each 
safety run-in evaluation.

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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 plus 90 days after the last dose of zimberelimab) and 
prior to the day of initiation of subsequent antineoplastic therapy, will be summarized by cohort 
and treatment group (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, the number and 
percentage of patients will be summarized. For continuous safety data, including laboratory data, 
the number of patients, mean, SD, minimum, quartiles, median, and maximum will be 
summarized.
8.6.3.
Extent of Exposure
A patient’s extent of exposure to study drug data will be generated from the study drug 
administration data. Exposure data will be summarized by cohort and treatment group.
8.6.4.
Adverse Events
Clinical and laboratory AEs will be coded using the Medical Dictionary for Regulatory 
Activities. 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 drug plus 30 days (or 90 days after the last dose of zimberelimab) and 
prior to the day of initiation of subsequent antineoplastic therapy.
Summaries (number and percentage of patients) of treatment-emergent AEs (by system organ 
class and preferred term) will be provided by cohort and treatment group.
8.6.5.
Laboratory Evaluations
Selected laboratory data (using conventional units) will be summarized using only observed data. 
Data and change from baseline at all scheduled time points will be summarized.
Graded laboratory abnormalities will be defined using the grading scheme in Appendix 4.
Incidence of treatment-emergent laboratory abnormalities, defined as values that increase at least 
1 toxicity grade from baseline at any time point postbaseline, up to and including the date of last 
dose of study drug plus 30 days (or 90 days after the last dose of zimberelimab) and prior to the 
day of initiation of subsequent antineoplastic therapy for patients who permanently discontinue 
study drug, will be summarized by cohort and treatment group. If baseline data are missing, then 
any graded abnormality (ie, at least Grade 1) will be considered treatment emergent.
Laboratory abnormalities that occur before the first dose of study drug or after the patient has 
been discontinued from treatment for at least 30 days (or 90 days after the last dose of 
zimberelimab) and prior to the day of initiation of subsequent antineoplastic therapy will be 
included in a data listing.

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Other Safety Evaluations 
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Other safety measures will be summarized by coho1t and treatment group, when appropriate. 
Details will be provided in the statistical analysis plan. 
8.7. 
Pharmacokinetic Analysis 
The PK Analysis Set will be used for summaries of PK concentration of magrolimab versus time. 
Sernm concentrations will be listed and summarized for magrolimab using descriptive statistics 
by sampling time point and treatment. Graphical plots of mean concentration versus time profiles 
by treatment will be generated. All data from this study may be combined with PK data from 
other Gilead clinical studies and analyzed using a population PK model. Such an analysis would 
be reported separately. If data allows, an exposure versus response (efficacy and/or safety) 
analysis may be conducted and repo1ted separately. Phannacokinetic analyses for zimberelimab 
may be perfo1med and repo1ted, as appropriate. Zimberelimab PK data from this study may be 
pooled with data from other studies to perfo1m population PK analysis and will be reported 
separately. 
8.8. 
Immunogenicity Analysis 
Immunogenicity will be assessed using a 3-tier screen, confnmato1y, and titer approach on study 
samples. The rate and magnitude of anti-magrolimab antibody incidence, prevalence, 
persistence, and transience will be summari 
• • 
• 
• 
Antidrng antibody analyses for zimberelimab may be perfo1med and 
repo1t ed separately, as appropriate. 
8.9. 
Biomarker Analysis 
The baseline level, absolute level, and change from baseline level over time will be summarized 
using descriptive statistics for each biom 
• 
• 
• 
• 
will be described in a separate Biomarker Analysis Plan. 
8.10. 
Analysis of Patient-Reported Outcome Data 
Changes from baseline in the EORTC QLQ-C30, EORTC QLQ-H&N35, and EQ-5D-5L 
questionnaires will be calculated. 
8.11. 
Sample Size 
For Phase 2 Cohort 1 Ann A versus Alm B, a total of 93 PFS events provides 75% power at a 
I-sided alpha of0.15 to detect an HR of0.7 (assuming median PFS of7 months compared with a 
control group median PFS of 4.9 months) using an unstratified log-rank test. Assuming an 
accrnal period of 15 months, a minimum follow-up time of 5 months, and a 10% annual drop-out 
rate, 66 patients per treatment group (Ann A versus Alm B) would be required to obtain 
93 events. Once the Phase 2 Cohort 1 emolls 20 patients in each Alm A and Alm B, Alm C will 
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open. For Arm C versus Arm B, a total of 61 PFS events provides 64% power at a 1-sided alpha 
of 0.15 to detect an HR of 0.7 (assuming a median PFS of 7 months compared with a control 
group median PFS of 4.9 months) using an unstratified log-rank test. Assuming an approximate 
accrual of 11 months, a minimum follow-up time of 5 months, and a 10% annual drop-out rate, 
46 patients per treatment arm (Arm C versus concurrent Arm B) would be required to obtain 
61 events. The control group assumption is based on pembrolizumab + platinum + 5-FU efficacy 
in a historical study (KEYNOTE-048) {Burtness 2019}. The power calculation was performed 
using EAST 6.5.
For Phase 2 Cohort 2, no formal sample size calculation has been performed (25 patients).
For Phase 2 Cohort 3, a sample size of 40 patients provides 83% power at a 1-sided alpha of 0.15 
to detect an ORR of 18% compared with a null ORR of 7.9% using a chi-squared test. The null 
ORR is based on historical taxane efficacy data in the second-line setting {Cohen 2019, Ferris 
2016}. The power calculation was performed using nQuery 8.0.

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9_ 
9.1. 
9.1.1. 
RESPONSIBILITIES 
Investigator Responsibilities 
Good Clinical Practice 
Final 
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The investigator will ensure that this study is conducted in accordance with International Council 
for Haim onisation (of Technical Requirements for Phai·maceuticals for Human Use) (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 an angements with Gilead or proprietaiy interests in the study dmg during 
the course of a clinical study. This documentation must be provided prior to the investigator's 
(and any subinvestigator's) paiticipation in the study. The investigator and subinvestigator agree 
to notify Gilead of any change in repo1iable 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, ICF, and any accompanying material to be provided to the patient (such as 
adve1tisements, patient info1mation sheets, or descriptions of the study used to obtain info1med 
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 necessaiy to 
reduce immediate risk to study patients. 
9.1.4. 
Informed Consent 
The investigator is responsible for obtaining written infonned consent from each individual 
paiticipating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazai·ds of the study before unde1taking any study-related procedures. The investigator 
must use the most cunent IRB- or !EC-approved ICF for documenting written info1m ed consent. 
Each ICF ( 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 
impaitial witness (if required by IRB or IEC or local requirements). 
The results of the tests perfo1m ed on the samples will not be given to the 
patient or the investigator. 
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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, case report forms (CRFs)/eCRFs, study drug information, and any other study 
information, remain 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 study 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, CRFs/eCRFs, IRB/IEC and 
governmental approval with correspondence, the ICF, 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 patient meets eligibility criteria (ie, medical history, physical 
examination, and confirmation of diagnosis [to support inclusion and exclusion criteria])
•
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

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•
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, and including 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, 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 study 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
For each patient consented, an eCRF casebook will be completed by an authorized study staff 
member whose training for this function is completed in the electronic data capture (EDC) 
system. The eCRF casebook will only capture the data required per the protocol schedules of 
assessments. The Inclusion/Exclusion Criteria and Enrollment eCRFs should be completed only 
after all data related to eligibility have been received. Data entry should be performed in 
accordance with the CRF Completion Guidelines provided by the sponsor. Subsequent to data 
entry, a study monitor will perform source data verification within the EDC system. 
System-generated or manual queries will be issued in the EDC system as data discrepancies are 
identified by the monitor or Gilead staff 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. At a minimum, prior to database lock (as instructed by Gilead), 
the investigator will use his/her login credentials 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 by that site. This archive must be stored in accordance with the records retention 
requirements outlined in Section 9.1.6.

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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 IRBs/IECs, 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 may be made only by the sponsor.
9.2.2.
Study Report and Publications
A clinical study report will be prepared and provided to the regulatory agency. 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.
Investigators in this study may communicate, orally present, or publish in scientific journals or 
other scholarly media only after the following conditions have been met:
•
The results of the study in their entirety have been publicly disclosed by or with the consent 
of Gilead in an abstract, manuscript, or presentation form or the study has been completed at 
all study sites for at least 2 years.
•
The investigator will submit to Gilead any proposed publication or presentation along with 
the respective scientific journal or presentation forum at least 30 days before submission of 
the publication or presentation.
•
No such communication, presentation, or publication will include Gilead’s confidential 
information (Section 9.1.5).
•
The investigator will comply with Gilead’s request to delete references to its confidential 
information (other than the study results) in any paper or presentation and agrees to withhold 
publication or presentation for an additional 60 days in order to obtain patent protection if 
deemed necessary.
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff 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, 
travel expenses or reimbursements, consulting fees, and any other transfer of value.

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9.3.2.
Access to Information for Monitoring
The monitor is responsible for routine review of the CRF/eCRF 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 monitor should have access to any patient records needed to 
verify the entries in the CRF/eCRF. The investigator agrees to cooperate with the monitor to 
ensure that any problems detected through any type of monitoring (central, 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 medical 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, IRBs, and IECs. 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.
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Jaiswal S, Jamieson CH, Pang WW, Park CY, Chao MP, Majeti R, et al. CD47 Is Up-Regulated 
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lymphoma: A multicenter, single-arm, phase II study. Eur J Cancer 2021.
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mediated destruction of immunogenic tumors. Nat Med 2015b;21 (10):1209-15.
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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Schedules of Assessments
Appendix 3.
Pandemic Risk Assessment and Mitigation Plan
Appendix 4.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements
Appendix 6.
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire – Core Questionnaire (EORTC QLQ-C30)
Appendix 7.
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire – Head and Neck Module (EORTC QLQ-H&N35)
Appendix 8.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
Appendix 9.
Eastern Cooperative Oncology Group (ECOG) Performance Status
Appendix 10.
Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1)
Appendix 11.
Adapted Immune-Related Response Evaluation Criteria in Solid Tumors 
(irRECIST) Criteria
Appendix 12.
Country-Specific Considerations
Appendix 13.
Authorization Status of Study Interventions
Appendix 14.
Amendment History
 

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Appendix 1.
Investigator Signature Page
GILEAD SCIENCES, INC.
333 LAKESIDE DRIVE
FOSTER CITY, CA 94404
CLINICAL STUDY PROTOCOL ACKNOWLEDGMENT
A Phase 2 Study of Magrolimab Combination Therapy in Patients with Head and Neck 
Squamous Cell Carcinoma
GS-US-548-5916 Amendment 6, 01 November 2023
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval.
[See appended electronic signature]
Name (Printed)
Medical Monitor
Signature
[See appended electronic signature]
Date
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
PPD

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Appendix 2.
Schedules of Assessments
Appendix Table 1.
Schedule of Assessments–Screening and Treatment Period
Cycle (21-Day Cycles)
1a
2a
3a
4+a
Visit Window (Days)
None
± 3b
± 3b
± 3b
± 3b
Cycle Day
Screening
Days −30 to −1
1
2
8
15
1
8
15
1
1
Informed consent
X
Demographics
X
Medical and cancer history
X
ECOG
X
X
X
X
X
Vital signs, height, and weightc
X
X
X
X
X
X
X
X
X
Physical examinationd
X
X
X
X
X
X
X
X
ECG (single)
X
Pregnancy teste
X
X
X
X
X
Hematologyb,f
X
Xf
X
Xf
X
X
X
X
X
X
Haptoglobin and LDHb
X
X
X
Serum or plasma chemistryb
X
X
X
X
X
X
X
X
X
Coagulationg
X
Thyroid panelb, h
X
X
X, Q2C
Blood phenotyping or genotyping, type and screen 
(ABO/Rh), DAT
X
Diagnostic Tissue Testing: PD-L1 and p16 HPVi
X
Urinalysisb, j
X
Tumor imagingk
X
X
Xk
Tumor biopsy (all patients)
X
Xl
Adverse eventsm, hh
X
X
X
X
X
X
X
X
X
X
Concomitant medicationshh
X
X
X
X
X
X
X
X
X
X
Randomizationn
X
PRO assessment: EORTC QLQ-C30, EORTC 
QLQ-H&N35, and EQ-5D-5Lb
X
X
X
X

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Cycle (21-Day Cycles)
1a
2a
3a
4+a
Visit Window (Days)
None
± 3b
± 3b
± 3b
± 3b
Cycle Day
Screening
Days −30 to −1
1
2
8
15
1
8
15
1
1
Receptor occupancyo
X
X
X
X
X (C5 and C10)
Circulating tumor DNAp
X
X
X
X
Xp (C5 and C10)
PBMCq
X
X
X
X
X
Xq (C5)
Serum and plasma biomarkersr, s
X
X
X
X
X
X
Xr (C5 and C10)
Whole blood RNAr, s
X
X
X
X
X
Xr (C5 and C10)
Immunophenotyping assayq, s
X
X
X
X
X
Xq (C5)
TCR sequencingq
X
X
X
X
Xq (C5)
Stool microbiomet
X
Whole blood genomicu
X
PK (Magrolimab)v, w
X
 X
X
X
X
X (C5 and C10)
PK (Zimberelimab)x
X
X
Antidrug antibodies (Magrolimab)y
X
X
X
X
Antidrug antibodies (Zimberelimab)z
X
X
IRT registrationaa
X
X
X
X
X
X
X
X
X
All Cohorts, except Phase 2 Cohort 1 Arm B
Premedication for magrolimabbb
X
X
Magrolimabcc
Xf
Xf
X
X
X
X
X
X
Safety Run-in 1, Pre-expansion Safety Run-in for Magrolimab + Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2 Only:
Pembrolizumabdd
X
X
X
X
Phase 2 Cohort 1 Arm C Only
Zimberelimabdd
X
X
X
X
Safety Run-in 1 and Phase 2 Cohort 1 Only:
Cisplatin or carboplatinee
X
X
X
X (C4-6)
5-FUff
X
X
X
X (C4-6)
Safety Run-in 2 and Phase 2 Cohort 3 Only:
Docetaxelgg
X
X
X
X

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5-FU = 5-fluorouracil; ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; ADA = antidrug antibody; aPTT = activated partial thromboplastin time; 
C = Cycle; DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EORTC QLQ-C30 = European Organisation for the 
Research and Treatment of Cancer Quality of Life Questionnaire – Core Questionnaire; EORTC QLQ-H&N35 = European Organisation for the Research and Treatment of Cancer 
Quality of Life Questionnaire – Head and Neck; EQ-5D-5L = 5-level EuroQol 5 dimensions; FT4 = free thyroxine; HPV = human papilloma virus; INR = international normalized 
ratio; IRT = interactive response technology; LDH = lactate dehydrogenase; PBMC = peripheral blood mononuclear cell; PD-L1 = programmed cell death ligand 1; 
PK = pharmacokinetic(s); PRO = patient-reported outcome; PT = prothrombin time; PTT = partial thromboplastin time; Q2C = every 2 cycles; RECIST = Response Evaluation 
Criteria in Solid Tumors; Rh = rhesus; RP2D = recommended Phase 2 dose; T3 = triiodothyronine; TCR = T-cell receptor; TSH = thyroid-stimulating hormone
a
In cases of magrolimab repriming following a treatment delay (Section 5.9.1), efficacy, biomarker, PK, and immunogenicity assessments should follow the schedule of the 
assigned cycle number. Magrolimab dosing and safety assessments should follow Cycle 1 (refer to Table 2 to Table 7, as appropriate) and then subsequently switch back to 
the assigned cycle schedule. If repriming is necessary before the patient completes Cycle 1 or Cycle 2, the repriming cycle is administered by repeating Cycle 1 dosing, 
followed by Cycle 2 before proceeding to Cycle 3. Magrolimab should not be given on consecutive days. Refer to footnote (aa) for premedication requirement.
b
Pretreatment assessments are to be collected within 24 hours (hemoglobin for the first 2 magrolimab doses per Section 7.8.1.2, PRO assessment) and within 3 days (safety 
labs) prior to any study treatment administration. For patients in Phase 2 Cohort 1 Arm B, assessments are not required at Cycle 1 Days 2, 8, and 15 and Cycle 2 Days 8 and 
15.
c
Height will be collected at screening only. Vital sign measurements will be collected predose on the same day as infusion of any study treatment. Weight will be collected at 
screening and on Day 1 of each cycle. For patients in Phase 2 Cohort 1 Arm B, vital signs are not required at Cycles 1 and 2 Days 8 and 15.
d
A complete physical examination is to be performed at screening, and symptom-directed physical examinations are to be performed from Cycle 1 Day 1. For patients in Phase 
2 Cohort 1 Arm B, physical examination is not required at Cycle 1 Days 8 and 15 and Cycle 2 Day 15.
e
A serum pregnancy test will be conducted at screening. The Cycle 1 Day 1 urine pregnancy test does not need to be conducted if the screening pregnancy test was performed 
within 3 days before study treatment administration. Urine pregnancy tests will also be conducted at Cycle 2 Day 1 and every cycle thereafter.
f
A complete blood count with differential, platelets, and reticulocytes will be conducted. For patients in Phase 2 Cohort 1 Arm B, samples are not required at Cycle 1 Days 2, 
8, and 15 and Cycle 2 Days 8 and 15. Additional hemoglobin and hematocrit measurements will be performed 3 to 6 hours after the initiation of the first and second doses of 
magrolimab during initial treatment (Section 7.8.1.2).
g
The analytes to be tested are PT, INR, and aPTT (or PTT).
h
Thyroid tests to be completed are T3 (total or free), FT4, and TSH.
i
PD-L1 results must be received prior to enrolling a patient in Phase 2 Cohorts 1 and 2. Known PD-L1 and p16 HPV results are acceptable providing protocol-specified assays 
were used for testing and results are available for source verification.
j
Reflex microscopic testing based on other abnormalities.
k
Computed tomography/magnetic resonance imaging/positron emission tomography-computed tomography (that includes a contrast-enhanced computed tomography 
component) will be performed per Section 6.6, every 6 weeks (2 cycles) until 36 weeks (Cycle 12) and then every 9 weeks (3 cycles) during the study (starting from Cycle 1 
Day 1). Per RECIST criteria, if a patient achieves an initial objective response on imaging, an imaging assessment at least 4 weeks later is required for confirmed response. 
Confirmation of disease progression through a subsequent response assessment at least 4 weeks apart may also be considered per Section 3.4. The on-treatment imaging 
window is ± 7 days.
l
The Cycle 3 Day 1 tumor biopsy can be collected any time between Cycle 3 Day 1 and Cycle 4 Day 1.
m
During screening, record only serious adverse events related to protocol-mandated procedures.
n
Phase 2 Cohort 1 screening must be completed before randomization. Randomization must occur within 30 days of signing informed consent. The first dose of study 
treatment must be given within 3 business days after randomization.
o
Receptor occupancy will be collected at select sites, only from patients assigned to receive magrolimab. Samples will be collected predose within 12 hours prior to receiving 
magrolimab. After Cycle 3, samples are to be collected on Day 1 of Cycles 5 and 10 and end of treatment, if occurring before Cycle 10.
p
Circulating tumor DNA samples will be collected predose within 12 hours prior to any study treatment administration. After Cycle 3, samples are to be collected on Day 1 of 
Cycles 5 and 10 and at end of treatment. For patients in Phase 2 Cohort 1 Arm B, samples are not required at Cycle 1 Day 15.
q
Samples will be collected predose within 12 hours prior to any study treatment administration. After Cycle 3, samples are to be collected on Day 1 of Cycle 5. PBMC and 
immunophenotyping assay samples will be collected at select sites. For patients in Phase 2 Cohort 1 Arm B, samples are not required at Cycle 1 Days 8 and 15.

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r
Samples will be collected predose within 12 hours prior to any study treatment administration. After Cycle 3, samples are to be collected on Day 1 of Cycles 5 and 10 and at 
end of treatment, if occurring before Cycle 10.
s
For patients who receive magrolimab, an additional sample for serum and plasma biomarkers, whole blood RNA, and immunophenotyping assay will be collected 4 hours 
(± 30 minutes) after the start of administration of magrolimab on Cycle 1 Day 8.
t
Stool microbiome to be collected predose on or before Cycle 1 Day 1.
u
Whole blood genomic sample can be obtained at a subsequent visit if not obtained at Cycle 1 Day 1.
v
On Cycle 3 Day 1, PK samples are to be collected predose (within 12 hours prior to magrolimab administration) and at 1 hour (± 15 minutes) after the end of infusion of 
magrolimab.
w
Samples for magrolimab PK assessments are to be collected within 12 hours prior to magrolimab administration on Day 1 of Cycles 1, 2, 3, 5, and 10; on Days 8 and 15 of 
Cycle 1; and at end of treatment.
x
Samples for zimberelimab PK assessments are to be collected within 12 hours prior to magrolimab administration and at the end of infusion (+15 minutes) on Day 1 of 
Cycles 1 and 3.
y
Samples for magrolimab ADA assessments are to be collected within 12 hours prior to magrolimab administration on Day 1 of Cycles 1, 2, 3, 5, 10, and at the end of 
treatment.
z
Samples for zimberelimab ADA assessments are to be collected within 12 hours prior to magrolimab administration on Day 1 of Cycles 1 and 3.
aa
Interactive response technology registration will be required for screening, enrollment/randomization, and when dispensing any study drug supplied by Gilead Sciences.
bb
Premedication with acetaminophen, diphenhydramine, and dexamethasone, or a comparable regimen, is required prior to the administration of the first 2 doses of magrolimab 
and in case of reintroduction with repriming (Section 5.9.2).
cc
Magrolimab will be administered first before pembrolizumab or zimberelimab, cisplatin/carboplatin, 5-FU, and docetaxel. Patients should be monitored for 1 hour after 
infusion during Cycle 1. Postinfusion monitoring should begin after the infusion is complete but prior to administering any other study drug. Postinfusion monitoring is not 
required for doses after Cycle 1 Day 15.
dd
Pembrolizumab or zimberelimab will always be administered after magrolimab. Pembrolizumab or zimberelimab may be administered on Day 2 of each cycle at the 
investigator’s discretion for administrative reasons or to accommodate the patient’s schedule.
ee
Cisplatin or carboplatin will always be administered after magrolimab and pembrolizumab. To accommodate the patient’s schedule, platinum chemotherapy may be dosed on 
Day 2 of each cycle at the investigator’s discretion.
ff
5-Fluorouracil will always be administered after magrolimab, pembrolizumab or zimberelimab as a continuous intravenous infusion over 4 days. To accommodate the 
patient’s schedule, 5-FU may be dosed on Day 2 of each cycle at the investigator’s discretion.
gg
Docetaxel will be administered after magrolimab.
hh
For patients in Phase 2 Cohort 1 Arm B, adverse event and concomitant medication assessments at Cycle 1 Days 2, 8, and 15 and Cycle 2 Days 8 and 15 may be completed 
via phone call.
Refer to Appendix 12 for zimberelimab monitoring requirements in Belgium.

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Appendix Table 2.
Schedule of Assessments – Posttreatment
EOT Visit
Safety Follow-Up Visit/Calla
Preprogression Visitc
Survival 
Follow-Up/Call
Within 7 Days After 
Last Dose or EOT 
Decision
30 Daysb After Last Dose
After Safety 
Follow-Up Until 
Disease Progression
Every 2 Months After 
Safety Follow-up Until 
Death or End of Study
Visit Window
± 7 Days
± 7 Days

± 7 Days
Urine pregnancy testd
X
X
X
X
Hematologye
X
Serum or plasma chemistry
X
Receptor occupancyf
X
Circulating tumor DNA
X
Serum and plasma biomarkersf
X
Whole blood RNAf
X
Pharmacokinetics
X
Antidrug antibodies
X
Tumor imaging for response assessmentg
X
X
ECOG
X
Vital signs
X
Symptom-directed physical examination
X
PRO assessment
X
Adverse eventsh
X
X
Concomitant medications
X
X
New anticancer therapy
X
X
Xi
Survival follow-up
Q2Mj

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AE = adverse event; ECOG = Eastern Cooperative Oncology Group; EOT = end of treatment; PRO = patient-reported outcome; Q2M = every 2 months; 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. Visit may be conducted by telephone or in 
person.
b
And at 90 days after the last dose for patients who receive treatment with zimberelimab or prior to the start of subsequent antineoplastic therapy, whichever occurs first.
c
This will only apply for patients who stop study treatment in the absence of disease progression and who will continue to have tumor imaging. See footnote (g) for details on 
tumor imaging schedule. Preprogression visits will be completed first before proceeding to survival follow-up.
d
Pregnancy testing will continue monthly up to 6 months after the end of treatment per the duration of required contraception, as discussed in Appendix 5. Testing during 
preprogression visits and survival follow-up may be done at home and the result self-reported by the patient.
e
A complete blood count with differential, platelets, and reticulocytes will be conducted.
f
Samples are to be collected at the end of treatment, if occurring before Cycle 10.
g
Tumor imaging at the EOT visit is not required if performed within the last 30 days or progressive disease has been documented. Computed tomography/magnetic resonance 
imaging/positron emission tomography-computed tomography (that includes a contrast-enhanced computed tomography component) will be performed per Section 6.6. For 
patients who stop study treatment in the absence of disease progression (eg, experienced unexpected toxicity), scans should continue to be collected approximately every 
6 weeks (2 cycles) until 36 weeks (12 cycles) from Cycle 1 Day 1 and then every 9 weeks (3 cycles) until disease progression or initiation of systemic antitumor therapy other 
than the study treatment, whichever is earlier.
h
Report all AEs through the safety follow-up visit/call and any treatment-related SAEs thereafter.
i
Collect new anticancer therapy data following the last dose of study treatment until the end of survival follow-up.
j
Survival follow-up will be conducted via a phone call or in person, as needed, every 2 months until death or end of study. Duration of survival follow-up will be limited to 
5 years.
Refer to Appendix 12 for zimberelimab monitoring requirements in Belgium.

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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. Special pandemic measures can be applied only 
when these are in accordance with the current situation and applicable local authority 
regulations, recommendations, or similar.
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 a virtual visit. 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 will not be able to stay on the study drug as planned per protocol.
Mitigation plan: If permitted by local ethics committee (EC)/institutional review 
board (IRB), non-investigational product as determined by the sponsor 
(ie, pembrolizumab, 5-fluorouracil, platinum, or 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 alternative clinic.
c) General patient selection guidance:
i)
To minimize patients receiving red blood cell transfusions, Gilead Sciences 
recommends selecting patients with higher hemoglobin thresholds at baseline and 
using 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 EC/IRB and national laws and regulations. Remote consent will be 
allowed if it has been approved by the local EC/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 COVID-19 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 a patient has a diagnosis of COVID-19 while participating in 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 during the study will be performed in accordance with local institutional 
guidelines. Patients who are diagnosed with COVID-19 while participating in this 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 clinical study report. 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 that cannot be mitigated due to the escalation of a 
pandemic, enrollment/randomization 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.
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 5.
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 ≥ 54 years of age with 
cessation of previously occurring menses for ≥ 12 months without an alternative cause. In 
addition, women of < 54 years of age with amenorrhea of ≥ 12 months may also 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.
Based on its mechanism of action and consistent with the risks identified for the approved 
anti-PD-1 agents, nivolumab and pembrolizumab, zimberelimab may cause fetal harm when 
administered to a pregnant woman. No contraindication to hormonal contraception is described 
in the zimberelimab investigator’s brochure. Refer to the latest version of the investigator’s 
brochure for additional information.
Based on its mechanism of action, pembrolizumab can cause fetal harm when administered to a 
pregnant woman. Animal models link the PD-1/PD-L1 signaling pathway with maintenance of 
pregnancy through induction of maternal immune tolerance to fetal tissue. Advise women of the 
potential risk to a fetus. There is no contraindication to hormonal contraception according to the 
pembrolizumab prescribing information.

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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 of 12 mg/kg 
caused teratogenicity. If this drug is used during pregnancy or if the patient becomes pregnant 
while taking this drug, the patient should be apprised of the potential hazard to a fetus. There is 
no contraindication to hormonal contraception according to the 5-FU prescribing information.
Based on human data from published literature, cisplatin for injection can cause fetal harm when 
administered to pregnant women. Data demonstrate transplacental transfer of cisplatin. Exposure 
of pregnant women to cisplatin-containing chemotherapy has been associated with 
oligohydramnios, intrauterine growth restriction, and preterm birth. Cases of neonatal acute 
respiratory distress syndrome, cytopenias, and hearing loss have been reported. Cisplatin for 
injection administration to animals during and after organogenesis resulted in teratogenicity. 
There is no contraindication to hormonal contraception according to the cisplatin prescribing 
information.
Based on animal studies, carboplatin has been shown to be embryotoxic and teratogenic in rats. 
There are no adequate and well-controlled studies in pregnant women. If this drug is used during 
pregnancy or if the patient becomes pregnant while receiving this drug, the patient should be 
apprised of the potential hazard to the fetus. There is no contraindication to hormonal 
contraception according to the carboplatin prescribing information.
Based on the mechanism of action and findings in animals, docetaxel can cause fetal harm when 
administered to a pregnant woman. Women of childbearing potential should be advised to use 
effective contraception and avoid becoming pregnant during therapy with docetaxel. If the 
patient becomes pregnant while receiving docetaxel, the patient should be apprised of the 
potential hazard to the fetus. There is no contraindication to hormonal contraception according to 
the docetaxel prescribing information.
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 < 1% per year. They must have a negative serum 
pregnancy test at screening, and a negative urine pregnancy test is required prior to study 
treatment administration on Cycle 1 Day 1. The Cycle 1 Day 1 urine pregnancy test does not 
need to be conducted if the screening pregnancy test was performed within 3 days before study 
treatment administration. Urine pregnancy tests will also be performed at Cycle 2 Day 1 and 
every cycle thereafter (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 the last dose of the latest administered study drug unless there 
is a longer time requirement described in the country-specific prescribing information. If the 
duration of contraception differs by study drug, the longest effective duration of contraception 
should be observed.

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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:
Non-hormonal 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
■
Transdermal combined contraceptive patch
■
Combined contraceptive vaginal ring
■
Progesterone-only 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

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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 and until 6 months after last dose of the latest administered study drug unless 
there is a longer time requirement described in the country-specific prescribing information. If 
the duration of contraception differs by study drug, the longest effective duration of 
contraception should be observed. 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.
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 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 last study drug dose must also report the information to the investigator. 
Partner pregnancy information will only be collected for the zimberelimab cohort in this study 
(throughout the study and for 120 days after the last dose of zimberelimab); however, the 
investigator should reinforce proper contraception use with the study patient if a partner 
pregnancy is reported in any cohort.
Instructions for reporting pregnancy and pregnancy outcome are outlined in Section 7.4.2.3.

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Appendix 6.
European Organisation for Research and Treatment of Cancer 
Quality of Life Questionnaire – Core Questionnaire 
(EORTC QLQ-C30)
https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-QLQ-C30-English.pdf

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Appendix 7.
European Organisation for Research and Treatment of Cancer 
Quality of Life Questionnaire – Head and Neck Module 
(EORTC QLQ-H&N35)
https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN35-English.pdf

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Appendix 8.
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 9.
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade
0
Fully active, able to carry on all pre-disease 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 10.
Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1)
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 11.
Adapted Immune-Related Response Evaluation Criteria in Solid 
Tumors (irRECIST) Criteria
Nishino M, Giobbie-Hurder A, Gargano M, Suda M, Ramaiya NH et al. Developing a Common 
Language for Tumor Response to Immunotherapy: Immune-related Response Criteria using 
Unidimentional measurements. Clin Cancer Res. 2013; 19(14):3936–3943.

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Appendix 12.
Country-Specific Considerations
Appendix Table 3.
France
Protocol Section
Consideration for France Only
Sections 3.6 and 6.13 
(Poststudy care)
The sponsor will continue to provide magrolimab to patients, free of charge, for 
3 years after completion of the study, subject to the following conditions:
•
The physician in charge of the study recommends that is in the best 
interest of the study patient to continue treatment with the study drug.
•
There is no suitable alternative medical treatment according to the 
Institutional Committee’s decision.
For patients receiving zimberelimab, an alternative, approved PD-1 inhibitor 
such as pembrolizumab may be substituted.
The sponsor will be exempt from providing the study drug after the study is 
completed in one of the following cases:
•
The product development has been discontinued or the clinical studies 
with the product ended unsuccessfully.
•
Administering the study drug for prolonged period of time is 
unsuitable for the patient and may harm the patient’s health.
•
When the study drug receives marketing authorization in the European 
Union in the indication under investigation in this study.
Appendix Table 4.
Belgium
Protocol Section
Consideration for Belgium Only
Schedule of Assessments 
Tables (Appendix Table 1 and 
Appendix Table 2)
Section 6.4.6
Section 7.8.3
Additional cardiac assessments for patients dosed with zimberelimab are added 
to study visits (see below).
On-Treatment Cardiac Monitoring Assessments
Cycle (21-Day Cycles)
1
2
3
4+
Visit Window (Days)
None
± 3
± 3
± 3
± 3
Cycle Day
Screening
Days −30 
to −1
1
2
8
15
1
8
15
1
1
Troponin Ia
X
As clinically indicated
12-lead ECGb
X
As clinically indicated
X
As clinically 
indicated
As clinically 
indicated
X
ECG = electrocardiogram
a
Additional cardiac biomarkers such as creatine kinase isoenzyme, brain natriuretic peptide, etc may be performed as 
clinically indicated. Assessments to be performed at the local laboratory. 
b
12-lead ECG to be performed at screening, Cycle 2 Day 1, Cycle 4 Day 1, then every 4 cycles. Additional ECG assessments 
may be performed as clinically indicated. 
In cases of suspected myocarditis, refer to Section 7.8.3, Table 24 and the international guidelines for recommendations on 
diagnostic tests and management including but not limited to cardiologist consultation, and cardiac functional tests such as 
echocardiography or cardiac magnetic resonance imaging as clinically indicated.
I 
I 
I 
I 
I 

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Posttreatment Cardiac Monitoring Assessments
EOT Visit
Safety Follow-up Visit/Call
Preprogression 
Visit
Survival 
Follow-Up/Call
Within 7 Days After 
Last Dose or EOT 
Decision
30 Days After Last Dose
After Safety 
Follow-Up Until 
Disease 
Progression
Every 2 Months 
After Safety 
Follow-Up Until 
Death or End of 
Study
Visit Window
± 7 Days
± 7 Days

± 7 Days
Troponin Ia
X
X
12-lead ECGb
X
X
ECG = electrocardiogram; EOT = end of treatment
a
Additional cardiac biomarkers such as creatine kinase isoenzyme, brain natriuretic peptide, etc may be performed as 
clinically indicated. Assessments to be performed at the local laboratory. 
b
12-lead ECG to be performed at EOT and 30-day safety follow-up visit. Additional ECG assessments may be performed as 
clinically indicated. 
In cases of suspected myocarditis, refer to Section 7.8.3, Table 24 and the international guidelines for recommendations on 
diagnostic tests and management including but not limited to cardiologist consultation, and cardiac functional tests such as 
echocardiography or cardiac magnetic resonance imaging as clinically indicated.

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Appendix 13.
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
Noa
NA
Zimberelimab
Study drug
Noa
NA
Pembrolizumab
Study drug
Yes
Yes
5-Fluorouracil
Study drug
Yes
Yes
Carboplatin
Study drug
Yes
Yes
Cisplatin
Study drug
Yes
Yes
Docetaxel
Study drug
Yes
Yes
Acetaminophen
AxMP
Yes
Yes
Diphenhydramine
AxMP
Yes
Yes
Dexamethasone
AxMP
Yes
Yes
AxMP = auxiliary medicinal product; EU = European Union; NA = not applicable
a
Rationale described in Section 1.

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Appendix 14.
Amendment History
A high-level summary of this amendment is provided in tabular form in Appendix Table 5 with 
changes listed in order of importance. Minor changes such as the correction of typographic 
errors, grammar, or formatting are not detailed.
Separate summary of change documents for earlier amendments are available upon request.
A separate tracked change (red-lined) document comparing Amendment 5 to this amendment 
will be made available upon the publication of this protocol.
Appendix Table 5.
Amendment 6 (01 November 2023)
Rationale for Key Changes Included in Amendment 6
Affected Sections
Nonclinical and clinical experience with zimberelimab was added to 
provide a rationale for the use of zimberelimab in Cohort 1 Arm C.
Sections 1.4 and 1.6
Objectives and endpoints were modified to indicate that disease 
progression will be determined by investigator assessment instead of 
independent central review.
Synopsis, Sections 2 and 3.1.2.1
Instructions outlining the duration of postinfusion monitoring of 
patients after zimberelimab infusion have been added to align with the 
pharmacy instructions for zimberelimab.
Section 5.11
Instructions on the administration of docetaxel have been added to 
allow for the infusion duration to follow local practice.
Section 5.14
The benefit/risk assessment of the study was updated with potential 
overlapping toxicities and their mitigation per the current clinical 
experience with magrolimab. 
Section 1.6
New sections for management of severe neutropenia and serious 
infections have been added. Cross-references to these sections have 
been added for further clarity on magrolimab dose delays with regards 
to these adverse events.
Sections 5.9.1, 7.8.1.6, and 7.8.1.7
Guidance for the management of IRRs has been updated.
Sections 1.2.3.2 and 7.8.1.3
Guidance for the management of zimberelimab toxicities has been 
updated.
Section 7.8.3
Criteria for permanent discontinuation of magrolimab has been 
updated to include recurrent Grade 3 IRRs despite premedication.
Section 5.9.1
A new segment of text was added to accommodate patient schedules 
regarding the administration of pembrolizumab, zimberelimab, and 
platinum chemotherapy. 
Section 5.16 and Appendix Table 1
Details for red blood cell phenotyping were added to clarify testing 
requirements.
Section 7.8.1.1
Text was updated for the monitoring and mitigation of anemia in 
patients with low baseline hemoglobin levels.
Section 7.8.1.2
Patient response assessments for secondary efficacy endpoints were 
updated to use Response Evaluation Criteria in Solid Tumors 
(RECIST) Version 1.1 in order to align with the table of objectives 
and endpoints.
Section 6.6

Magrolimab
Protocol GS-US-548-5916
Final
Gilead Sciences, Inc.
Amendment 6
CONFIDENTIAL
Page 162
01 November 2023
Rationale for Key Changes Included in Amendment 6
Affected Sections
Information on study auxiliary medicinal products/noninvestigational 
medicinal products has been added.
Section 1.3.11
A new segment of text outlining standard-of-care (SOC) procedures, 
performed prior to obtaining informed consent, was added to clarify 
that certain SOC assessments are allowed to be used for patient 
eligibility at the screening period.
Section 6.2.1
Exclusion criteria 24 and 26 were updated to remove “systemic” for 
clarity.
Synopsis and Section 4.3
Exclusion criterion 22 was modified  to allow patients with HIV who 
have undetectable HIV viral load to enroll.
Synopsis and Section 4.3
A sentence was added to clarify that questionnaires should be 
completed before any other study procedures with the exception of 
imaging and laboratory analyte assessments. A new sentence was also 
added to outline the exemptions for the completion of patient-reported 
outcomes (PRO) instruments if unavailable in patient’s language or 
other barriers.
Section 6.4.7
Country-specific considerations for Belgium have been added. 
References to the country-specific requirements appendix have also 
been added throughout the document, as applicable.
Sections 6.4.6, 6.5, Appendix Table 1, 
Appendix Table 2, and Appendix 12
Appendix Table 1 footnote ‘m’ was updated to only record serious 
adverse events related to protocol-mandated procedures during 
screening.
Appendix 2
Text updated to allow local sourcing of commercial product when 
aligned with local regulations.
Sections 5.3.2, 5.5.2, 5.6.2, 5.7.2, and 
5.8.2
An Authorization Status of Study Interventions table was added.
Appendix 13
Text clarifying the baseline value for patients who were not dosed was 
added.
Section 8.3.2
Text describing magrolimab contraindication in pregnancy has been 
updated to include nonclinical observations in embryo-fetal 
development.
Appendix 5
The reference for the Immune-Related Response Evaluation Criteria in 
Solid Tumors (irRECIST) Criteria has been updated.
Appendix 11
Global Patient Safety (GLPS) has changed to Patient Safety (PS) to 
reflect the new department name.
Throughout the protocol, as required
Minor changes were included to correct typographic errors.
Throughout the protocol, as required

Protocol GS-US-548-5916 Amend 6
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
02-Nov-2023
12:21:34
PPD-