A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer
Phase: PHASE2
Conditions: Triple-Negative Breast Cancer
Sponsor: Gilead Sciences

CLINICAL STUDY PROTOCOL
Study Title:
A Phase 2 Study of Magrolimab Combination Therapy in Patients 
With Unresectable, Locally Advanced or Metastatic 
Triple-Negative Breast Cancer
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
USA
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
154653
2021-001074-27
NCT04958785
Indication:
Triple-Negative Breast Cancer 
Protocol ID:
GS-US-586-6144
Contact Information:
The medical monitor name and contact information will be 
provided on the Key Study Team Contact List.
Protocol 
Version/Date:
Original:
04 March 2021
Amendment 1:
13 April 2021
Amendment 1.1-VHP:
18 October 2021
Amendment 2:
15 December 2021
Amendment 3:
27 January 2022
Amendment 1.2-UK:
03 February 2022
Amendment 3.1-UK:
17 March 2022
Amendment 3.1-KOR:
31 October 2022
Amendment 3.2-KOR:
01 February 2023
Amendment 4:
07 March 2023
Amendment 5:
30 October 2023
Amendment 6:
30 January 2024
This study will be conducted under United States Food and Drug Administration investigational 
new drug (IND) application regulations (21 Code of Federal Regulations Part 312); however, 
sites located in the European Economic Area, United Kingdom, and Switzerland are not included 
under the IND application and are not considered to be IND sites.
lr'J GILEAU 

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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The information contained in this document, particularly unpublished data, is the property or 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.

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TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................3
LIST OF APPENDICES.................................................................................................................................................7
LIST OF IN-TEXT TABLES .........................................................................................................................................7
LIST OF IN-TEXT FIGURES........................................................................................................................................8
PROTOCOL SYNOPSIS................................................................................................................................................9
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS ....................................................................23
1.
INTRODUCTION................................................................................................................................................26
1.1.
Background..............................................................................................................................................26
1.1.1.
Background on Triple-Negative Breast Cancer ....................................................................26
1.2.
Magrolimab .............................................................................................................................................27
1.2.1.
General Information ..............................................................................................................27
1.2.2.
Nonclinical Pharmacology and Toxicology ..........................................................................29
1.2.3.
Clinical Background for Magrolimab ...................................................................................30
1.3.
Information About Nab-paclitaxel, Paclitaxel, and Sacituzumab Govitecan..........................................33
1.3.1.
Description of Nab-paclitaxel................................................................................................33
1.3.2.
Description of Paclitaxel .......................................................................................................34
1.3.3.
Description of Sacituzumab Govitecan.................................................................................35
1.4.
Rationale for Cohort 1.............................................................................................................................36
1.4.1.
Rationale for Cohort 2...........................................................................................................37
1.5.
Rationale for Dose Selection of Magrolimab..........................................................................................37
1.5.1.
Safety Run-in Cohorts 1 and 2 and Phase 2 Cohorts 1 and 2................................................38
1.6.
Risk/Benefit Assessment for the Study ...................................................................................................38
1.7.
Compliance..............................................................................................................................................40
2.
OBJECTIVES AND ENDPOINTS......................................................................................................................41
3.
STUDY DESIGN.................................................................................................................................................43
3.1.
Study Design ...........................................................................................................................................43
3.1.1.
Safety Run-in Cohorts ...........................................................................................................44
3.1.2.
Phase 2 Cohorts .....................................................................................................................47
3.2.
Study Treatments.....................................................................................................................................49
3.2.1.
Safety Run-in Cohort 1 and Phase 2 Cohort 1 ......................................................................49
3.2.2.
Safety Run-in Cohort 2 and Phase 2 Cohort 2 ......................................................................50
3.3.
Duration of Treatment .............................................................................................................................51
3.4.
Discontinuation Criteria ..........................................................................................................................52
3.5.
Discontinuation From Study Criteria/End of Study ................................................................................53
3.6.
Poststudy Care.........................................................................................................................................53
3.7.
Source Data .............................................................................................................................................53
3.8.
Biomarker Samples to Address the Study Objectives.............................................................................53
3.8.1.
4.
PATIENT POPULATION ...................................................................................................................................56
4.1.
Number of Patients and Patient Selection ...............................................................................................56
4.1.1.
Patient Replacement ..............................................................................................................56
4.2.
Inclusion Criteria.....................................................................................................................................56
4.3.
Exclusion Criteria....................................................................................................................................58
5.
INVESTIGATIONAL MEDICINAL PRODUCTS.............................................................................................61
CCI

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5.1.
Randomization, Blinding, and Treatment Codes Access ........................................................................61
5.1.1.
Randomization.......................................................................................................................61
5.1.2.
Blinding .................................................................................................................................61
5.2.
Description and Handling of Magrolimab...............................................................................................61
5.2.1.
Formulation ...........................................................................................................................61
5.2.2.
Packaging and Labeling ........................................................................................................61
5.2.3.
Storage and Handling ............................................................................................................61
5.3.
Description and Handling of Nab-paclitaxel...........................................................................................62
5.3.1.
Formulation ...........................................................................................................................62
5.3.2.
Packaging and Labeling ........................................................................................................62
5.3.3.
Storage and Handling ............................................................................................................62
5.4.
Description and Handling of Paclitaxel...................................................................................................62
5.4.1.
Formulation ...........................................................................................................................62
5.4.2.
Packaging and Labeling ........................................................................................................62
5.4.3.
Storage and Handling ............................................................................................................63
5.5.
Description and Handling of Sacituzumab Govitecan ............................................................................63
5.5.1.
Formulation ...........................................................................................................................63
5.5.2.
Packaging and Labeling ........................................................................................................63
5.5.3.
Storage and Handling ............................................................................................................63
5.6.
Dosage and Administration of Magrolimab............................................................................................63
5.6.1.
Treatment Delay and Repriming for Magrolimab.................................................................64
5.7.
Dose Modifications, Delays, and Discontinuation for Magrolimab........................................................64
5.8.
Magrolimab Premedication and Prophylaxis ..........................................................................................67
5.9.
Prior and Concomitant Medications........................................................................................................67
5.9.1.
Prior and Concomitant Medications With Magrolimab ........................................................67
5.9.2.
Prior and Concomitant Medications With Nab-paclitaxel and Paclitaxel.............................68
5.9.3.
Prior and Concomitant Medications With Sacituzumab Govitecan......................................68
5.10.
Dosage and Administration of Nab-paclitaxel and Paclitaxel.................................................................69
5.11.
Nab-paclitaxel and Paclitaxel Premedication and Prophylaxis...............................................................70
5.12.
Dose Modifications for Nab-paclitaxel and Paclitaxel............................................................................70
5.12.1.
Hematologic Toxicity............................................................................................................70
5.12.2.
Neurological Toxicity............................................................................................................71
5.12.3.
Hepatic Toxicity ....................................................................................................................71
5.12.4.
Pneumonitis ...........................................................................................................................72
5.12.5.
Other Toxicities.....................................................................................................................72
5.13.
Dosage and Administration of Sacituzumab Govitecan..........................................................................73
5.13.1.
Sacituzumab Govitecan.........................................................................................................73
5.14.
Sacituzumab Govitecan Premedication and Prophylaxis........................................................................74
5.15.
Dose Modifications for Sacituzumab Govitecan.....................................................................................75
5.15.1.
Treatment Delays for Sacituzumab Govitecan......................................................................75
5.15.2.
Dose Reductions and Discontinuation for Sacituzumab Govitecan......................................76
5.16.
Accountability for Investigational Medicinal Product ............................................................................78
5.16.1.
Investigational Medicinal Product Return or Disposal .........................................................78
6.
STUDY PROCEDURES......................................................................................................................................79
6.1.
Patient Enrollment and Treatment Assignment.......................................................................................79
6.2.
Pretreatment Assessments .......................................................................................................................79
6.2.1.
Prescreening ..........................................................................................................................79
6.2.2.
Screening Visit ......................................................................................................................79
6.3.
Randomization.........................................................................................................................................80
6.4.
Treatment Assessments ...........................................................................................................................80
6.4.1.
Pregnancy Test ......................................................................................................................80
6.4.2.
Type and Screen and Direct Antiglobulin Test .....................................................................81
6.4.3.
Vital Signs .............................................................................................................................81

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6.4.4.
Physical Examination ............................................................................................................81
6.4.5.
Performance Status................................................................................................................81
6.4.6.
Electrocardiograms................................................................................................................81
6.4.7.
Patient-reported Outcomes ....................................................................................................82
6.4.8.
Adverse Events......................................................................................................................82
6.4.9.
Concomitant Medications......................................................................................................83
6.5.
Safety Assessments .................................................................................................................................83
6.6.
Efficacy Assessments ..............................................................................................................................84
6.7.
Pharmacokinetic Assessments.................................................................................................................85
6.8.
Immunogenicity (Antidrug Antibodies)..................................................................................................86
6.9.
Biomarker Assessments...........................................................................................................................86
6.10.
Posttreatment Assessments......................................................................................................................87
6.11.
Assessments for Early Discontinuation From Study...............................................................................87
6.11.1.
Criteria for Discontinuation of Study Treatment...................................................................87
6.12.
Criteria for Discontinuation From Study/End of Study ..........................................................................87
6.13.
Poststudy Care.........................................................................................................................................87
6.14.
Sample Storage........................................................................................................................................88
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT................................................................................89
7.1.
Definitions of Adverse Events and Serious Adverse Events...................................................................89
7.1.1.
Adverse Events......................................................................................................................89
7.1.2.
Serious Adverse Events.........................................................................................................89
7.1.3.
Study Drugs and Gilead Concomitant Therapy Special Situations Reports .........................90
7.2.
Assessment of Adverse Events and Serious Adverse Events..................................................................91
7.2.1.
Assessment of Causality for Study Drugs and Procedures ...................................................92
7.2.2.
Assessment of Severity..........................................................................................................92
7.3.
Investigator Reporting Requirements and Instructions ...........................................................................92
7.3.1.
Requirements for Collection Prior to Study Drug Initiation .................................................92
7.3.2.
Adverse Events......................................................................................................................92
7.3.3.
Serious Adverse Events.........................................................................................................92
7.3.4.
Study Drug Special Situations Reports .................................................................................93
7.3.5.
Concomitant Therapy Reports...............................................................................................93
7.4.
Reporting Process for Serious Adverse Events and Special Situation Reports.......................................94
7.4.1.
Serious Adverse Event Reporting Process ............................................................................94
7.4.2.
Special Situations Reporting Process ....................................................................................94
7.5.
Gilead Reporting Requirements ..............................................................................................................96
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events...........................................................................................................................97
7.7.
Abnormal Liver Function Tests...............................................................................................................97
7.8.
Toxicity Management..............................................................................................................................97
7.8.1.
Magrolimab ...........................................................................................................................97
7.8.2.
Nab-paclitaxel and Paclitaxel..............................................................................................103
7.8.3.
Sacituzumab Govitecan.......................................................................................................104
8.
STATISTICAL CONSIDERATIONS...............................................................................................................106
8.1.
Analysis Objectives and Endpoints.......................................................................................................106
8.2.
Planned Analyses...................................................................................................................................106
8.2.1.
Dose-Determination Analysis .............................................................................................106
8.2.2.
Primary Analysis .................................................................................................................106
8.2.3.
Final Analysis......................................................................................................................106
8.3.
Analysis Conventions............................................................................................................................106
8.3.1.
Analysis Sets .......................................................................................................................106
8.3.2.
Data Handling Conventions ................................................................................................108
8.4.
Demographic and Baseline Characteristics Analysis............................................................................108

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8.5.
Efficacy Analysis...................................................................................................................................109
8.5.1.
Primary Efficacy Endpoint Analysis...................................................................................109
8.5.2.
Secondary Efficacy Endpoint Analyses ..............................................................................109
8.6.
Safety Analysis......................................................................................................................................109
8.6.1.
Primary Safety Endpoint Analysis ......................................................................................109
8.6.2.
Other Safety Analysis..........................................................................................................110
8.6.3.
Extent of Exposure ..............................................................................................................110
8.6.4.
Adverse Events....................................................................................................................110
8.6.5.
Laboratory Evaluations .......................................................................................................110
8.6.6.
Other Safety Evaluations.....................................................................................................111
8.7.
Pharmacokinetic Analysis .....................................................................................................................111
8.8.
Immunogenicity Analysis......................................................................................................................111
8.9.
Biomarker Analysis...............................................................................................................................111
8.10.
Analysis of Patient-Reported Outcome Data ........................................................................................111
8.11.
Sample Size ...........................................................................................................................................111
8.12.
Gilead Data Review Committee............................................................................................................112
9.
RESPONSIBILITIES.........................................................................................................................................113
9.1.
Investigator Responsibilities .................................................................................................................113
9.1.1.
Good Clinical Practice.........................................................................................................113
9.1.2.
Financial Disclosure ............................................................................................................113
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval..............................................................................................................................113
9.1.4.
Informed Consent ................................................................................................................113
9.1.5.
Confidentiality.....................................................................................................................114
9.1.6.
Study Files and Retention of Records .................................................................................114
9.1.7.
Case Report Forms ..............................................................................................................115
9.1.8.
Investigator Inspections.......................................................................................................116
9.1.9.
Protocol Compliance ...........................................................................................................116
9.2.
Sponsor Responsibilities .......................................................................................................................116
9.2.1.
Protocol Modifications ........................................................................................................116
9.2.2.
Study Report and Publications ............................................................................................116
9.3.
Joint Investigator/Sponsor Responsibilities ..........................................................................................117
9.3.1.
Payment Reporting ..............................................................................................................117
9.3.2.
Access to Information for Monitoring.................................................................................117
9.3.3.
Access to Information for Auditing or Inspections .............................................................117
9.3.4.
Study Discontinuation .........................................................................................................117
10.
REFERENCES...................................................................................................................................................118
11.
APPENDICES....................................................................................................................................................123

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LIST OF APPENDICES
Appendix 1.
Investigator Signature Page...................................................................................................124
Appendix 2.
Schedules of Assessments .....................................................................................................125
Appendix 3.
Pandemic Risk Assessment and Mitigation Plan ..................................................................136
Appendix 4.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities ........................................................................................................................140
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements..................................................................................................141
Appendix 6.
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire–Core Questionnaire (EORTC-QLQ-C30) and Breast Cancer Module 
(EORTC-QLQ-BR23) ...........................................................................................................145
Appendix 7.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L).................................................146
Appendix 8.
Eastern Cooperative Oncology Group (ECOG) Performance Status....................................149
Appendix 9.
American Society of Clinical Oncology/College of American Pathologists 
Guidelines..............................................................................................................................150
Appendix 10.
Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1) ...............................151
Appendix 11.
UGT1A1 Inducers and Inhibitors..........................................................................................152
Appendix 12.
Country-Specific Requirements ............................................................................................153
Appendix 13.
Amendment History ..............................................................................................................154
LIST OF IN-TEXT TABLES
Table 1.
Study Objectives and Endpoints..............................................................................................41
Table 2.
Stopping Boundary Due to Toxicity (Phase 2 Cohort 1 Arm A) ............................................48
Table 3.
Stopping Boundary Due to Toxicity (Phase 2 Cohort 2).........................................................49
Table 4.
Safety Run-in Cohort 1: Dose Level, Schedule, and De-escalation........................................49
Table 5.
Phase 2 Cohort 1: Dose Level and Schedule...........................................................................50
Table 6.
Safety Run-in Cohort 2: Dose Level, Schedule, and De-escalation........................................50
Table 7.
Phase 2 Cohort 2: Dose Level and Schedule...........................................................................51
Table 8.
Repriming Guidelines for Magrolimab (Safety Run-in Cohort 1 and Phase 2 Cohort 
1)..............................................................................................................................................66
Table 9.
Repriming Guidelines for Magrolimab (Safety Run-in Cohort 2 and Phase 2 Cohort 
2)..............................................................................................................................................66
Table 10.
Magrolimab Dosing Guidance for Planned Surgical Procedures on Study.............................67
Table 11.
Nab-paclitaxel and Paclitaxel Reductions for Hematologic Toxicity .....................................71
Table 12.
Nab-paclitaxel and Paclitaxel Dose Reductions for Neurological Toxicity............................71
Table 13.
Nab-paclitaxel and Paclitaxel Dose Reductions for Hepatic Toxicity ....................................72
Table 14.
Nab-paclitaxel and Paclitaxel Dose Reductions for Nonhematologic, 
Nongastrointestinal, Nonneurologic, and Nonhepatic Toxicity, Nonpneumonitis 
Toxicity....................................................................................................................................73
Table 15.
Guidance for Premedication and Prophylaxis for Toxicities Associated With 
Sacituzumab Govitecan ...........................................................................................................74
Table 16.
Recommended Dose Modification Schedule for Sacituzumab Govitecan..............................77
Table 17.
Screening Laboratory Analytes ...............................................................................................83
Table 18.
Study Laboratory Analytes......................................................................................................84
Table 19.
Management of Pneumonitis.................................................................................................102

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LIST OF IN-TEXT FIGURES
Figure 1.
Effect of Magrolimab on Anemia and Mitigation With a Priming/Maintenance 
Dosing Regimen ......................................................................................................................32
Figure 2.
Study Schema ..........................................................................................................................44

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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 
Unresectable, Locally Advanced or Metastatic Triple-Negative Breast 
Cancer
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
154653
2021-001074-27
NCT04958785
Study Centers 
Planned:
Approximately 50 centers
Objectives and 
Endpoints:
Primary Objectives
Primary Endpoints
Safety Run-in Cohort 1:
•
To evaluate the safety, 
tolerability, and recommended 
Phase 2 dose (RP2D) of 
magrolimab in combination with 
nab-paclitaxel or paclitaxel
Phase 2 Cohort 1:
•
To compare the efficacy of 
magrolimab in combination with 
nab-paclitaxel or paclitaxel 
versus nab-paclitaxel or 
paclitaxel alone as determined by 
progression-free survival (PFS) 
by investigator assessment 
Safety Run-in Cohort 2:
•
To evaluate the safety, 
tolerability, and RP2D of 
magrolimab in combination with 
sacituzumab govitecan
Cohort 2 (Safety Run-in Cohort 2 and 
Phase 2 Cohort 2):
•
To evaluate the efficacy of 
magrolimab in combination with 
sacituzumab govitecan as 
determined by confirmed 
objective response rate (ORR) by 
investigator assessment
Safety Run-in Cohorts 1 and 2:
•
Incidence of dose-limiting toxicities 
(DLTs), adverse events (AEs), and 
laboratory abnormalities according to 
National Cancer Institute (NCI) 
Common Terminology Criteria for 
Adverse Events (CTCAE), Version 5.0 
Phase 2 Cohort 1:
•
PFS, defined as the time from the date 
of randomization until the earliest date 
of documented disease progression as 
determined by investigator assessment 
using Response Evaluation Criteria in 
Solid Tumors (RECIST), Version 1.1, 
or death from any cause, whichever 
occurs first
Cohort 2 (Safety Run-in Cohort 2 and 
Phase 2 Cohort 2):
•
Confirmed ORR (defined as the 
proportion of patients who achieve 
complete response or partial response 
that is confirmed at least 4 weeks after 
initial documentation of response), as 
determined by investigator assessment 
per RECIST, Version 1.1

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Secondary Objectives
Secondary Endpoints
Phase 2 Cohort 1:
•
To compare the efficacy between 
treatment arms by ORR by 
investigator assessment 
•
To compare the efficacy between 
treatment arms by additional 
measures of efficacy, including 
duration of response (DOR) and 
overall survival (OS)
•
To compare the safety and 
tolerability between treatment 
arms
Cohort 2 (Safety Run-in Cohort 2 and 
Phase 2 Cohort 2): 
•
To evaluate PFS by investigator 
assessment
•
To evaluate additional measures 
of efficacy of magrolimab in 
combination with sacituzumab 
govitecan, including DOR and 
OS
•
Safety and tolerability of 
magrolimab in combination with 
sacituzumab govitecan
Safety Run-in Cohorts 1 and 2 and 
Phase 2 Cohorts 1 and 2:
•
To evaluate the pharmacokinetics 
(PK) and immunogenicity of 
magrolimab in combination with 
anticancer chemotherapies
Phase 2 Cohort 1 and Cohort 2 (Safety 
Run-in Cohort 2 and Phase 2 Cohort 2):
•
Confirmed ORR, as determined by 
investigator assessment per RECIST, 
Version 1.1 (only for Phase 2 Cohort 1)
•
PFS, as determined by investigator 
assessment per RECIST, Version 1.1, 
or death from any cause, whichever 
occurs first (only for Cohort 2)
•
DOR, defined as time from first 
documentation of complete response or 
partial response to the earliest date of 
documented disease progression as 
determined by investigator assessment, 
per RECIST, Version 1.1, or death from 
any cause, whichever occurs first 
•
OS, defined as time from date of 
randomization to death from any cause
•
Incidence of AEs and laboratory 
abnormalities according to NCI 
CTCAE, Version 5.0
Safety Run-in Cohorts 1 and 2 and Phase 2 
Cohorts 1 and 2:
•
Magrolimab concentration versus time 
and antidrug antibodies (ADA) to 
magrolimab 
CCI

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Study Design:
This is a Phase 2, randomized (Phase 2 Cohort 1 only), open-label, 
multicenter study to evaluate magrolimab in combination with either 
nab-paclitaxel or paclitaxel for patients with untreated, unresectable, 
locally advanced or metastatic triple-negative breast cancer (mTNBC) 
and magrolimab in combination with sacituzumab govitecan for patients 
with unresectable, locally advanced or mTNBC who have received at 
least 1 and no more than 2 prior lines of treatment in the advanced setting. 
This study will consist of 2 Safety Run-in Cohorts:
•
Safety Run-in Cohort 1: magrolimab in combination with choice of 
nab‑paclitaxel or paclitaxel in patients previously untreated for 
unresectable, locally advanced or mTNBC whose tumors are not 
appropriate for immune checkpoint inhibitor therapy
After completion of Safety Run-in Cohort 1, Phase 2 Cohort 1 will be 
open to enrollment.
•
Phase 2 Cohort 1: a randomized, open-label cohort of magrolimab in 
combination with choice of nab‑paclitaxel or paclitaxel (Experimental 
Arm A) versus nab‑paclitaxel or paclitaxel (Control Arm B) in 
patients previously untreated for unresectable, locally advanced or 
mTNBC whose tumors are not appropriate for immune checkpoint 
inhibitor therapy.
•
Safety Run-in Cohort 2: magrolimab in combination with 
sacituzumab govitecan in patients with unresectable, locally advanced 
or mTNBC who have received at least 1 and no more than 2 prior 
lines of treatment in the unresectable, locally advanced or metastatic 
setting.
After completion of Safety Run-in Cohort 2, Phase 2 Cohort 2 will be 
open to enrollment.
•
Phase 2 Cohort 2: magrolimab in combination with sacituzumab 
govitecan in patients with unresectable, locally advanced or mTNBC 
who have received at least 1 and no more than 2 prior lines of 
treatment in the unresectable, locally advanced or metastatic setting.
The study schematic is provided below.

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mTNBC = metastatic triple-negative breast cancer; N = number of patients; R = ratio; 
RP2D = recommended Phase 2 dose 
Safety Run-in Cohort 1 and Safety Run-in Cohort 2: Initially, up to 
6 patients will be enrolled in each Safety Run-in Cohort at a starting dose 
level. A DLT evaluation period of 1 cycle (28 days) for Cohort 1 and 
(21 days) for Cohort 2 will occur.
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 2 or less of 6 DLT-evaluable patients experience a DLT in Cycle 1, 
enrollment into Phase 2 Cohort 1 or Phase 2 Cohort 2 may begin at 
this dose level as the RP2D.
•
If more than 2 patients experience at least one DLT during Cycle 1, 
enrollment at the current dose level will immediately stop and dose 
de-escalation will occur. Up to another 6 patients will then be enrolled 
and evaluated at a lower dose level in the same manner. 
Approximately 18 patients (each cohort) could be potentially enrolled and 
evaluated during the Safety Run-in Cohorts.
DLT Assessment Period for Safety Run-in Cohort 1: The DLT 
assessment period will be the first cycle (28 days). Patients are considered 
evaluable for assessment of a DLT if either of the following criteria is 
met in the DLT assessment period:
•
The patient experienced a DLT at any time after initiation of the first 
infusion of magrolimab.
Untreated 
unresectable locally 
advanced or mTNBC 
patients who are not 
eligible for immune 
check point inhibitors 
Unresectable locally 
advanced or mTNBC 
patients who have 
received one prior 
line of treatment in 
the unresectable 
locally advanced or 
metastatic setting 
Safety Run-in Cohort 1 
N=6-18 
Phase 2 Cohort 1 
N=28 
Maerolimab 
+ Nab-paclitaxel 
or Paclitaxel 
ArmA: 
• 
Magrolimab • 
• 
______. 
Nab-paclitaxel or Paclitaxel 
~N•_14 
Safety Run-in Cohort 2 
N=6-18 
Maerolimab 
+ sacituzumab 
11ovitecan 
Arm B: 
Nab-paclitaxel 
or Paclitaxel 
N•14 
Phase 2 Cohort 2 
N=40 
Magrolimab + 
sacituzumab govitecan 
N•40 

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•
The patient did not experience a DLT and completed at least 
3 infusions of magrolimab (28-day cycle), and at least 2 doses of 
nab-paclitaxel or paclitaxel in Safety Run-in Cohort 1.
DLT Assessment Period for Safety Run-in Cohort 2: The DLT 
assessment period will be the first cycle (21 days). Patients are considered 
evaluable for assessment of a DLT if either of the following criteria is 
met in the DLT assessment period:
•
The patient experienced a DLT at any time after initiation of the first 
infusion of magrolimab.
•
The patient did not experience a DLT and completed at least 
2 infusions of magrolimab (21-day cycle), and at least 2 infusions of 
sacituzumab govitecan in Safety Run-in Cohort 2.
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 
Cohorts will be replaced.
The DLT definition is provided in the main protocol (Section 3.1.1.2).
Phase 2 Cohort 1: Once Safety Run-in Cohort 1 is completed and the 
RP2D for magrolimab in combination with either nab-paclitaxel or 
paclitaxel is determined, the sponsor will open Phase 2 Cohort 1. In this 
open-label, randomized, 2-arm cohort, unresectable, locally advanced or 
mTNBC patients will be randomized in a 1:1 ratio to receive either 
magrolimab in combination with the choice of nab-paclitaxel or paclitaxel 
(Experimental Arm A) or nab-paclitaxel or paclitaxel (Control Arm B). 
The primary efficacy assessment will be investigator-assessed PFS. In the 
original study design, the primary analysis was to occur after 63 events; 
however, due to the early closure of Phase 2 Cohort 1, the primary 
analysis will occur when every enrolled patient has a minimum of 
6 months follow-up. Stratification factors for randomization include the 
following: 1) receipt versus nonreceipt of neoadjuvant and/or adjuvant 
taxane therapy, 2) presence versus absence of liver metastases, 3) 
treatment with nab-paclitaxel versus paclitaxel.
Phase 2 Cohort 2: Once Safety Run-in Cohort 2 is completed and the 
RP2D for magrolimab in combination with sacituzumab govitecan is 
determined, the sponsor will open Phase 2 Cohort 2. In this open-label 
single-arm cohort, unresectable, locally advanced or mTNBC patients 
will receive magrolimab in combination with sacituzumab govitecan. The 
primary efficacy assessment will be investigator-assessed confirmed 
ORR.

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Number of 
Patients Planned:
Approximately 104 patients total
•
Safety Run-in Cohort 1: approximately 6 to 18 patients
•
Phase 2 Cohort 1: approximately 28 patients
•
Safety Run-in Cohort 2: approximately 6 to 18 patients
•
Phase 2 Cohort 2: approximately 40 patients
Target Population: Phase 2 Cohort 1: Previously untreated patients with unresectable, 
locally advanced or mTNBC whose tumors are not appropriate for 
immune checkpoint inhibitor therapy who do not express programmed 
death ligand 1 (PD-L1), as determined by an approved test according to 
local standards.
Phase 2 Cohort 2: Patients with unresectable locally advanced or 
mTNBC who have received at least 1 and no more than 2 prior lines of 
treatment in the unresectable, locally advanced or metastatic setting.
Duration of 
Treatment:
Cohort 1: Cycle lengths are 28 days. All patients will continue study 
treatment unless they meet study treatment discontinuation criteria.
Cohort 2: Cycle lengths are 21 days. All patients will continue study 
treatment unless they meet study treatment discontinuation criteria.
Diagnosis and 
Main Eligibility 
Criteria:
Inclusion Criteria:
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, at least 18 years of age.
4) Patients must have an Eastern Cooperative Oncology Group (ECOG) 
performance status of 0 or 1.
5) Laboratory measurements, blood counts:
a) Hemoglobin must be ≥ 9 g/dL prior to initial dose of study 
treatment. Red blood cell (RBC) transfusions are allowed to meet 
hemoglobin eligibility within limits set per Exclusion 
Criterion #4, except in South Korea.
b) Absolute neutrophil count at least 1.5  109/L without growth 
factor support within 2 weeks of study treatment initiation.
c) Platelets at least 100  109/L.

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6) Laboratory measurements, renal function:
a) Patients must have adequate renal function as demonstrated by a 
creatinine clearance of at least 30 mL/min; calculated by the 
Cockcroft Gault formula.
7) Adequate liver function, as demonstrated by:
a) Aspartate aminotransferase less than or equal to 2.5  upper limit 
of normal (ULN) or less than or equal to 5  ULN in patients with 
liver metastases.
b) Alanine aminotransferase less than or equal to 2.5  ULN or less 
than or equal to 5  ULN in patients with liver metastases.
c) Bilirubin less than or equal to 1.5  ULN, or less than or equal 
to 3.0  ULN and primarily unconjugated if patient has a 
documented history of Gilbert’s syndrome or genetic equivalent.
8) Pretreatment blood cross-match completed.
9) 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.
10) Measurable disease according to RECIST, Version 1.1. Previously 
irradiated lesions can be considered as measurable disease only if 
disease progression has been unequivocally documented at that site 
since radiation.
11) Patients must have a life expectancy of 3 months or greater, in the 
opinion of the investigator.
Safety Run-in Cohort 1 and Phase 2 Cohort 1
In addition to meeting the inclusion criteria for all patients, patients who 
are enrolled into Safety Run-in Cohort 1 and Phase 2 Cohort 1 must fulfill 
the following cohort-specific inclusion criteria:
12) Patients previously untreated with systemic therapy for unresectable 
locally advanced or metastatic breast cancer and with a diagnosis of 
TNBC that is histologically or cytologically confirmed based on the 
most recent analyzed biopsy or other pathology specimen, defined as 
negative for estrogen receptor (ER), progesterone receptor (PR), and 
human epidermal growth factor receptor 2 (HER2) according to the 
most recent American Society of Clinical Oncology/College of 
American Pathologists (ASCO/CAP) guideline (Appendix 9).
13) Patients whose tumors are considered PD-L1 negative, as determined 
by an approved test according to local standards.
14) Prior systemic treatment for neoadjuvant and/or adjuvant therapy 
and/or curative intent radiation therapy is permitted if completed at 
least 6 months prior to enrollment.

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Note: Maintenance therapies are not counted as separate lines of therapy.
Safety Run-in Cohort 2 and Phase 2 Cohort 2
In addition to meeting the inclusion criteria for all patients, patients who 
are enrolled into Safety Run-in Cohort 2 and Phase 2 Cohort 2 must fulfill 
the following cohort-specific inclusion criteria:
15) Patients with unresectable, locally advanced or metastatic breast 
cancer with a diagnosis of TNBC that is histologically or 
cytologically confirmed based on the most recent analyzed biopsy or 
other pathology specimen, defined as negative for ER, PR, and HER2 
according to the most recent ASCO/CAP guideline (Appendix 9), 
who have received at least 1 and no more than 2 prior lines of 
systemic therapy in the unresectable, locally advanced/metastatic 
setting. Patients must have been previously treated with a taxane in 
the neoadjuvant, adjuvant, or locally advanced/metastatic setting. 
16) Patients with tumors considered positive for PD-L1 expression (as 
determined by an approved test according to local standards) must 
have received an immune checkpoint inhibitor for a prior line of 
treatment for locally advanced/metastatic disease.
Exclusion Criteria:
Patients who meet any of the following exclusion criteria are not to be 
enrolled in this study:
1) Positive serum pregnancy test.
2) Breastfeeding female.
3) Active central nervous system (CNS) disease. Patients with 
asymptomatic and stable, treated CNS lesions who have been off 
steroids, radiation and/or surgery, and/or other CNS-directed therapy 
for at least 4 weeks are allowed. 
4) RBC transfusion dependence, defined as requiring more than 2 units 
of packed RBC transfusions during the 4-week period prior to 
screening. RBC transfusions are permitted during the screening period 
and prior to enrollment to meet the hemoglobin inclusion criteria, 
except in South Korea.
5) History of hemolytic anemia, autoimmune thrombocytopenia, or 
Evans syndrome in the last 3 months.
6) Known hypersensitivity to any of the study drugs, the metabolites, or 
formulation excipient.
7) Prior treatment with CD47 or signal regulatory protein alpha-targeting 
agents.

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8) Current participation in another interventional clinical study. Patients 
enrolled in a clinical study who are no longer receiving therapeutic 
intervention are eligible.
9) Known inherited or acquired bleeding disorders.
10) 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. Additional information for sites in the United Kingdom 
(UK) is provided in Appendix 12.
11) 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 2 years.
12) Known active or chronic hepatitis B or C infection or human 
immunodeficiency virus infection in medical history.
13) Uncontrolled pleural effusion. 
14) Uncontrolled hypercalcemia (Grade 2 or higher) or symptomatic 
hypercalcemia requiring continued use of bisphosphonate therapy.
15) Rapid deterioration during screening prior to enrollment (eg, 
significant change in performance status, 20% or greater decrease in 
serum albumin levels or uncontrolled tumor-related pain).
16) Severe/serious systemic infection within 4 weeks of randomization or 
any active, uncontrolled infection requiring systemic therapy within 
7 days of enrollment. 
17) Other concurrent medical or psychiatric conditions that, in the 
investigator’s opinion, may be likely to confound study interpretation 
or prevent completion of study procedures and follow-up 
examinations.
18) Prior anticancer therapy within the specified timeframes prior to start 
of magrolimab is not permitted: 2 weeks for chemotherapy agents, 
endocrine therapy, or targeted small molecule therapy; 3 weeks for 
monoclonal antibodies, antibody-drug conjugates, immunotherapy, or 
investigational agents.
19) Patients who have received a live vaccine within 30 days of 
randomization.

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Safety Run-in Cohort 1 and Phase 2 Cohort 1
Patients who meet the following exclusion criterion are not eligible to be 
enrolled into Safety Run-in Cohort 1 or Phase 2 Cohort 1:
20) Disease progression within 6 months following neoadjuvant/adjuvant 
therapy or prior lines of systemic therapy for unresectable locally 
advanced or metastatic breast cancer. 
NOTE: Localized non-CNS radiotherapy, hormonal therapy for breast 
cancer in the curative setting, and treatment with bisphosphonates and 
receptor activator of nuclear factor kappa B ligand inhibitors are not 
included in Exclusion Criterion #20. Patients should be recovered from 
the effects of radiation. Additional information for sites in the UK is 
provided in Appendix 12.
Safety Run-in Cohort 2 and Phase 2 Cohort 2
Patients who meet any of the following exclusion criteria are not eligible 
to be enrolled into Safety Run-in Cohort 2 or Phase 2 Cohort 2:
21) Patients with active chronic inflammatory bowel disease (ulcerative 
colitis, Crohn disease) and patients with a history of bowel 
obstruction or gastrointestinal perforation within 6 months of 
enrollment. 
22) Patients who previously received topoisomerase I inhibitors or 
antibody-drug conjugates containing a topoisomerase inhibitor.
23) High-dose systemic corticosteroids (≥ 20 mg of prednisone or its 
equivalent) are not allowed within 2 weeks of Cycle 1 Day 1.
24) Have not recovered (ie, ≥ Grade 2 is considered not recovered) from 
AEs due to a previously administered agent
Note: patients with any grade of neuropathy, alopecia, hypo- or 
hyperthyroidism, or other endocrinopathies that are well 
controlled with hormone replacement are an exception to this 
criterion and will qualify for the study.
Note: if patients received major surgery, they must have recovered 
adequately from the toxicity and/or complications from the 
intervention prior to starting therapy.
NOTE: Localized non-CNS radiotherapy is not criteria for exclusion. 
Patients should be recovered from the effects of radiation.
Study Procedures/
Frequency:
Refer to Appendix Table 1, Appendix Table 2, and Appendix Table 3.

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Test Product, 
Dose, and Mode of 
Administration:
Safety Run-in Cohort 1 Starting Doses:
•
Magrolimab 1 mg/kg intravenous (IV) (priming)
•
Magrolimab 30 mg/kg IV every week for the first 2 cycles and 
magrolimab 30 mg/kg IV every 2 weeks for Cycle 3 and onward
In combination with nab-paclitaxel 100 mg/m2 IV or paclitaxel 90 mg/m² 
IV per investigator discretion.
Experimental Arm A of Phase 2 Cohort 1:
Magrolimab dose will be determined in Safety Run-in Cohort 1.
In combination with nab-paclitaxel 100 mg/m2 IV or paclitaxel 90 mg/m² 
IV per investigator discretion.
Safety Run-in Cohort 2 Starting Doses:
•
Magrolimab 1 mg/kg IV (priming)
•
Magrolimab 30 mg/kg IV every week for the first 2 cycles and 
magrolimab 60 mg/kg IV every 3 weeks for Cycle 3 and onward
In combination with sacituzumab govitecan 10 mg/kg IV.
Phase 2 Cohort 2:
Magrolimab dose will be determined in Safety Run-in Cohort 2.
In combination with sacituzumab govitecan 10 mg/kg IV.
Reference 
Therapy, Dose, 
and Mode of 
Administration
Control Arm B of Phase 2 Cohort 1:
Nab-paclitaxel 100 mg/m² IV or paclitaxel 90 mg/m² IV per investigator 
discretion
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 examination, 12-lead electrocardiogram, ECOG performance 
status, and vital signs measurements. Adverse events will be graded using 
NCI CTCAE, Version 5.0.
Efficacy:
Cohort 1 (Phase 2 only): Efficacy will be evaluated by PFS, ORR, DOR, 
OS, and PRO assessment (EORTC-QLQ-C30, EORTC-QLQ-BR23, and 
EQ-5D-5L) scores. Assessment of response will be measured by 
RECIST, Version 1.1.
Cohort 2: Efficacy will be evaluated by PFS, ORR, DOR, and OS. 
Assessment of response will be measured by RECIST, Version 1.1.

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Pharmacokinetics: Magrolimab serum drug concentrations will be assessed at predose at 
multiple time points until study discontinuation. Peripheral blood for 
immunogenicity assessments for ADA against magrolimab will also be 
collected at predose and multiple time points during the study.
Statistical 
Methods:
Analysis Data Sets
The DLT-Evaluable Analysis Set for Safety Run-in Cohort 1 will include 
all patients who meet 1 of the following criteria in the DLT assessment 
period:
•
Patient experienced a DLT at any time after initiation of the first 
infusion of magrolimab.
•
Patient did not experience a DLT and completed at least 3 infusions 
of magrolimab (28-day cycle) and at least 2 doses of nab-paclitaxel or 
paclitaxel in Safety Run-in Cohort 1.
The DLT-Evaluable Analysis Set for Safety Run-in Cohort 2 will include 
all patients who meet 1 of the following criteria in the DLT assessment 
period:
•
Patient experienced a DLT at any time after initiation of the first 
infusion of magrolimab.
•
Patient did not experience a DLT and completed at least 2 infusions 
of magrolimab (21-day cycle) and at least 2 infusions of sacituzumab 
govitecan in Safety Run-in Cohort 2.
For Safety Run-in Cohorts, the modified Intent-to-Treat (ITT) Analysis 
Set will include all patients who received at least 1 dose of any study drug 
and the Safety Analysis Sets will include all patients who received at least 
1 dose of any study drug.
For Phase 2 Cohort 1, the ITT Analysis Set will include all randomized 
patients according to the treatment arm to which the patients are 
randomized, unless otherwise specified. The Safety Analysis Set will 
include all randomized patients who received at least 1 dose of any study 
treatment, with treatment assignments designated according to the actual 
treatment received.
For Phase 2 Cohort 2, the Safety Analysis Set will include all patients 
who received at least 1 dose of any study drug.
For Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2), the 
modified ITT Analysis Set will include all patients who received at least 
1 dose of study drug at the selected Phase 2 Cohort 2 dose level.
The PK Analysis Set will include all patients who received any amount of 
magrolimab and have at least 1 measurable posttreatment serum 
concentration of magrolimab.

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The Immunogenicity Analysis Set will include all patients who received 
any amount of magrolimab and had at least 1 evaluable anti-magrolimab 
antibody test result.
The Biomarker Analysis Set includes all patients who received any study 
drug and have at least 1 evaluable biomarker measurement available. This 
will be the primary analysis set for all biomarker data analyses.
Dose-Determination Analysis
For the purposes of making the dose de-escalation decisions for Safety 
Run-in Cohort 1 and 2, dose-determination analyses of relevant safety 
data focusing on DLTs and overall safety profile will be conducted by the 
sponsor after all patients have completed the required DLT assessment 
period as specified in Section 3.1.1. Safety assessments (eg, AEs, 
electrocardiogram, laboratory results) will be displayed to facilitate the 
dose de-escalation decisions.
Efficacy Analysis
For Phase 2 Cohort 1, PFS by investigator assessment will be analyzed 
using Kaplan-Meier (KM) methods. Patients who did not have 
documented disease progression or death will be censored at the date of 
their last adequate 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 may be used to compare treatment 
difference in PFS. A Cox proportional hazard regression model may be 
used to estimate the hazard ratio (HR) and its 2-sided 95% CI.
For Safety Run-in Cohort 2 and Phase 2 Cohort 2, confirmed ORR by 
investigator assessment with 95% CI based on the Clopper-Pearson 
method will also be estimated. Patients who do not have sufficient 
baseline or on-study tumor assessment 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.
Sample Size Calculation
Based on the original design for Phase 2 Cohort 1, using an unstratified 
log-rank test, a total of 63 PFS events provides 82% power at a 1-sided 
alpha of 0.15 to detect a HR of 0.61 (assuming median PFS of at 
least 9 months compared to a control arm median PFS of 5.5 months). 

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Assuming an accrual period of 15 months, a minimum follow-up time of 
6 months, and a 5% annual drop-out rate, 92 total patients (46 patients per 
arm) would be required to obtain 63 events.
Due to the early closure of Phase 2 Cohort 1, 28 patients have been 
enrolled and randomized for Arm A and Arm B. The analysis of the PFS 
given the current sample size is under powered and will be descriptive 
only.
For Safety Run-in Cohort 2 and Phase 2 Cohort 2, using chi-square test, a 
total of 46 patients (including 6 patients in Safety Run-in Cohort 2 and 
40 in Phase 2 Cohort 2) provides 88% power at a 1-sided alpha of 0.15 to 
detect an ORR of 50% compared with a null ORR of 34%.
Power calculations were performed using EAST 6.5.
This study will be conducted in accordance with the guidelines of Good Clinical Practice, 
including archiving of essential documents.

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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
5F9
magrolimab
1L
first-line
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
ASCO
American Society of Clinical Oncology
AST
aspartate aminotransferase
CAP
College of American Pathologists
CD47
cluster of differentiation 47
CI
confidence interval
CMV
cytomegalovirus
CNS
central nervous system
COVID-19
Coronavirus Disease 2019
CPS
Combined Positive Score
CRC
colorectal cancer
CRF
case report form
CRO
contract research organization
CSR
clinical study report
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
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EDC
electronic data capture
ELISA
enzyme-linked immunosorbent assay
EORTC-QLQ-C30
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire - Core Questionnaire
EORTC-QLQ BR23
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire - Core Questionnaire–Breast Cancer Module
EOT
end of treatment
EQ-5D
EuroQol (5 dimensions)

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EQ-5D-5L
5-level EuroQol 5 dimensions
EQ-VAS
EuroQol visual analogue scale
ER
estrogen receptor
EU
European Union
Fc
crystallizable fragment
FDA
Food and Drug Administration
G-CSF
granulocyte-colony stimulating factor
GDRC
Gilead Data Review Committee
Gilead
Gilead Sciences
HER2
human epidermal growth factor receptor 2
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 G 4
IND
investigational new drug
IRB
institutional review board
IRR
infusion-related reaction
IRT
interactive response technology
ITT
intent-to-treat
IUD
intrauterine device
IV
intravenous
KD
dissociation constant
KM
Kaplan-Meier
mAb
monoclonal antibody
MDS
myelodysplastic syndromes
MedDRA
Medical Dictionary for Regulatory Activities
MOA
mechanism of action
MRI
magnetic resonance imaging
MTD
maximum tolerated dose
mTNBC
metastatic triple-negative breast cancer
nab
nanoparticle albumin-bound
NCI
National Cancer Institute
NHL
non-Hodgkin lymphoma
ORR
objective response rate
OS
overall survival
PBMC
peripheral blood mononuclear cell
PD
pharmacodynamic(s)

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PD-L1
programmed cell death ligand 1
PET
positron emission tomography
PFS
progression-free survival
PK
pharmacokinetic(s)
PR
progesterone receptor
PRO
patient-reported outcome
PS
Patient Safety
r/r
relapsed/refractory
RBC
red blood cell
RECIST
Response Evaluation Criteria in Solid Tumors
RNA
ribonucleic acid
RO
receptor occupancy
RP2D
recommended Phase 2 dose
SAE
serious adverse event
SIRPα
signal regulatory protein alpha
SOP
standard operating procedure
SRT
safety review team
SSRs
special situation reports
SUSAR
suspected unexpected serious adverse reaction
TCR
T-cell receptor
TEAE
treatment-emergent adverse event
TNBC
triple-negative breast cancer
Trop-2
trophoblast cell-surface antigen 2
UK
United Kingdom
ULN
upper limit of normal
US
United States
VAS
visual analogue scale
w/v
weight-to-volume ratio

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1.
INTRODUCTION
1.1.
Background
1.1.1.
Background on Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC) is defined by the absence of immunostaining for estrogen 
receptor, progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). 
Approximately 15% to 20% of all breast cancers are classified as TNBC. Generally, compared to 
other breast cancer subtypes, TNBC typically has more aggressive features, including a faster 
proliferation rate and a more invasive phenotype. Patients with locally advanced or metastatic 
TNBC (mTNBC) have a poor prognosis. Standard-of-care therapy for patients with mTNBC is 
chemotherapy. Taxane-based chemotherapeutic regimens are considered standard of care in 
first-line (1L) therapy for patients with mTNBC {Cardoso 2012}, with single-agent taxanes as 
the recommended chemotherapy regimen across international guidelines. However, even with 
these agents, the median overall survival (OS) is approximately 18 months or less {Cardoso 
2020, Gradishar 2020}. 
Taxane treatment can involve paclitaxel, nanoparticle albumin-bound (nab)paclitaxel, and 
docetaxel. While these 3 agents fall into the same taxane chemotherapeutic class, there are 
differences in terms of their safety profile, particularly between paclitaxel or nab-paclitaxel and 
docetaxel. Docetaxel has been associated with a more severe toxicity profile than paclitaxel or 
nab-paclitaxel, as well as a strict requirement for steroid premedication that cannot be tapered 
during the entire length of its administration. Nab-paclitaxel, which is an albumin-bound 
formulation of paclitaxel, was developed to avoid toxicities associated with administration of 
paclitaxel delivery-solution vehicles. Initial studies of nab-paclitaxel demonstrated higher 
antitumor activity as compared to paclitaxel in metastatic breast cancer. However, growing 
evidence suggests that paclitaxel and nab-paclitaxel may have a comparable benefit. Specifically, 
a study of the combination of paclitaxel or nab-paclitaxel with bevacizumab as 1L treatment for 
metastatic breast cancer, including mTNBC, was shown to provide similar progression-free 
survival (PFS) when given on a weekly basis {Rugo 2015}.
Moreover, results from the recent Phase 3 KEYNOTE 355 study evaluating pembrolizumab with 
a choice of chemotherapy in patients with previously untreated, locally recurrent, inoperable or 
metastatic TNBC whose tumors expressed programmed cell death ligand 1 (PD-L1) indicate 
generally a consistent benefit with regard to PFS irrespective of chemotherapy partner (including 
nab-paclitaxel or paclitaxel). The combinations were well tolerated, with no new safety concerns 
({Cortes 2020}, {Cortes 2020}NCT02819518). In patients with a high-level of PD-L1 
expression (Combined Positive Score [CPS] of at least 10) treated with pembrolizumab + nab-
paclitaxel versus placebo + nab-paclitaxel, PFS was 9.9 versus 5.5 months, with a hazard ratio 
(HR [95% CI]) of 0.57 (0.34-0.95), and 9.6 versus 3.6 months (HR: 0.33; 85% CI: 0.14-0.76) 
with pembrolizumab + paclitaxel versus placebo+ paclitaxel. The addition of pembrolizumab to 
chemotherapy significantly improved the median OS in patients with a CPS of at least 10 as 
compared to chemotherapy alone (23.0 months vs 16.1 months, respectively) at a median follow-
up of 44.1 months {Cortes 2021}. The pembrolizumab combination reduced the risk of death by 

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27% (HR: 0.73; 95% CI: 0.55-0.95; P = 0.0093). These results have served as the basis of 
pembrolizumab’s approval in patients with locally recurrent unresectable or mTNBC whose 
tumors express PD-L1 (CPS of at least 10) {Cortes 2020}.
Additional immune checkpoint inhibitor combinations with taxanes are being evaluated in the 
mTNBC setting. Efficacy to date has been observed in the PD-L1–positive setting; however, 
therapeutic advances including novel combinations are needed for patients whose tumors do not 
express PD-L1.
Patients with TNBC who have failed approved or accepted treatments in the first- and 
second-line setting remain in dire need of additional therapeutic approaches. The trophoblast 
cell-surface antigen 2 (Trop-2) antigen is highly expressed on most solid epithelial cancers, 
including TNBC. Sacituzumab govitecan is a Trop-2 targeted antibody with 
camptothecin-derived agent SN-38, a topoisomerase I inhibitor, as its payload that binds to 
Trop-2 for targeted delivery of SN-38 directly to the tumor cell while minimizing systemic 
exposure of SN-38 to decrease host toxicity. Results from the ASCENT study evaluating 
sacituzumab govitecan monotherapy in patients with locally advanced or mTNBC who had 
relapsed after at least 2 prior chemotherapies for breast cancer (1 of which could be in the 
neoadjuvant/adjuvant setting provided progression occurred within a 12-month period) showed 
benefit with regards to PFS against single-agent chemotherapy. Patients treated with sacituzumab 
govitecan had a median PFS of 5.6 months versus 1.7 months in the single-agent chemotherapy. 
The study also showed an improved OS of 12.1 months in the sacituzumab govitecan arm versus 
6.7 months in the chemotherapy arm {Bardia 2021}. The results of this study led to the approval 
of sacituzumab govitecan in patients with unresectable locally advanced or mTNBC who have 
received 2 or more prior systemic therapies, at least 1 of them for metastatic disease.
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 

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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 
crystallizable fragment (Fc)-dependent effector functions, although the presence of the 
immunoglobulin G 4 (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 (MOA) 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).
As described in Edition 8 of the magrolimab investigator’s brochure (IB), magrolimab is being 
investigated as an anticancer therapeutic in 6 ongoing clinical studies in the United States (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 magrolimab IB, Edition 8.
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. Consequently, magrolimab is being evaluated clinically in several 
combinations with cytotoxic agents including chemotherapy.
For further information on magrolimab, refer to the current IB.

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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 cell-mediated 
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. Treatment of AML cells with hydroxyurea had no effect 
on magrolimab-induced phagocytosis, nor did hydroxyurea treatment trigger 
magrolimab-induced phagocytosis of normal bone marrow cells. In contrast, the combination of 
magrolimab and avelumab effectively enhanced phagocytosis of ovarian cancer cells by human 
macrophages compared to magrolimab or avelumab alone. Moreover, the combination of 
magrolimab with cytotoxic agent azacitidine at a clinically relevant concentration enhanced 
phagocytosis of HL60 cells in vitro when compared to magrolimab or azacitidine 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 an additive 
effect on eliminating cancer cells, 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.
The safety pharmacology evaluations as part of a Good Laboratory Practice 8-week toxicology 
study demonstrated no magrolimab-related effects on central nervous system (CNS), 
cardiovascular, or respiratory function in cynomolgus monkeys.
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 

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and clinical chemistry parameters and erythroid cell morphology. Hematology changes included 
decreases in RBC mass associated with decreases in mean corpuscular volume and haptoglobin; 
increases in mean corpuscular hemoglobin concentration, reticulocytes, and RBC distribution 
width; RBC 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 except for 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, but all the 
available data (literature, data from knockout mice, and limited clinical data) suggest no role for 
CD47 in embryo-fetal development. Moreover, notably, a waiver has been granted by the 
US Food and Drug Administration (FDA) for conducting embryo-fetal studies for magrolimab, 
as in most cases magrolimab is utilized in combination with other products that most likely have 
contraindications in women of childbearing age.
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 and lymphomas. 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. 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 (10%) evaluable 
patients 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 a Phase 1 AML study (SCI-CD47-002), as in the solid tumor Phase 1 study, nonlinear 
PK consistent with target-mediated clearance was observed. Three of 20 (15%) evaluable 
patients 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).

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Preliminary PK data 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 (11%) patients 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, as noted above. 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 (r/r) AML, along with 2 Phase 1b 
partnered studies in AML as well as urothelial cancer. Four combination studies include the 
following: Study 5F9003, a Phase 1b/2 study of magrolimab with rituximab in patients with 
r/r 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 between 
approximately 0.4 to 1.5 g/dL across indications, with many patients’ hemoglobin improving on 
therapy back to baseline, with a decrease in RBC transfusion requirements for those patients who 
were transfusion-dependent at baseline.
Magrolimab has been evaluated as a monotherapy or in combination in multiple solid tumor 
types. In the Phase 1 Study SCI-CD47-001 of magrolimab monotherapy, 88 patients with 
advanced solid tumors were treated with magrolimab doses up to 45 mg/kg. No MTD was 
reached. As described in the 2020 IB, across 548 patients treated with magrolimab, which 
includes both solid tumors and hematologic malignancies, fatigue, anemia, and headache were 
the 3 most frequently reported AEs (43.0%, 40.8%, and 36.4% of patients, respectively). Patients 
experienced mostly Grade 1 and 2 fatigue (2.8% of patients reported severe fatigue).
Anemia is the most common treatment-related AE, reported in 35.4% of patients. Approximately 
13% of all patients experienced anemia Grade 1 or 2, and 22% severe anemia. Notably, many of 
those patients with severe anemia were patients with AML and MDS, who have 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 is on average 0.5 to 
2 g/dL. In patients with solid tumors, the fall in hemoglobin was followed by a compensatory 

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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 and are shown in Figure 1. Hyperbilirubinemia 
(predominately unconjugated) indicates 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
The red blood cell profile of a solid tumor patient 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. Most common signs/symptoms of IRRs 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 Sections 5.8 
and 7.8.1.3. 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.
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.
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In summary, as of July 2020, 568 patients (346 solid tumor/lymphoma patients and 
222 AML/MDS patients) 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 hematologic and solid tumor 
malignancies. In the Phase 1 Study SCI-CD47-001 of magrolimab monotherapy in advanced 
solid tumors, 2 patients with clear cell ovarian and fallopian tube carcinomas achieved a partial 
response 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 the Phase 1b/2 study of 
magrolimab in combination with cetuximab in r/r CRC patients (Study 5F9004), 2 objective 
responses among 32 patients (6%) were observed in r/r metastatic KRAS wildtype CRC patients 
who were refractory to cetuximab, with a disease control rate of 50% {Fisher 2020}. The OS in 
KRAS wildtype and KRAS mutant CRC patients treated with magrolimab and cetuximab was 
9.5 and 7.6 months, respectively. These data may compare favorably to historical data in KRAS 
wildtype and mutant patients treated with standard of care, with a median OS of 8.0 and 
6.5 months, respectively {Van Cutsem 2018}.
In hematologic malignancies, efficacy has been observed in NHL, MDS, and AML. In study 
5F9003, patients with r/r NHL were treated with magrolimab in combination with rituximab. In 
97 NHL patients evaluable for efficacy (malignancies included diffuse large B-cell lymphoma 
[DLBCL] and indolent lymphoma), the objective response rate (ORR) was 45%, with a complete 
response rate of 19%. The ORR in DLBCL was 36% in 59 patients and 61% for 38 indolent 
lymphoma patients treated. In Study 5F9005, patients with untreated AML ineligible for 
induction chemotherapy and untreated, higher-risk MDS patients were treated with magrolimab 
in combination with azacitidine. In 25 AML patients, the ORR was 64% and CR rate was 40%. 
In 33 MDS patients, the ORR was 91% and 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.
1.3.
Information About Nab-paclitaxel, Paclitaxel, and Sacituzumab Govitecan
1.3.1.
Description of Nab-paclitaxel
Nab-paclitaxel (Abraxane) is a nanoparticle albumin-bound microtubule inhibitor and taxane 
indicated for the treatment of metastatic breast cancer after failure of combination chemotherapy 
for metastatic disease. Nab-paclitaxel is also approved in some countries in combination with 
atezolizumab for adult patients with mTNBC whose tumors express PD-L1 {Abraxane® 2005 }.

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1.3.1.1.
Clinical Data for Nab-paclitaxel
Nab-paclitaxel is indicated for multiple cancer types, including metastatic breast cancer and 
mTNBC (for patients whose tumors express PD-L1), in combination with atezolizumab 
{Abraxane® 2005 }.
The most common AEs (at least 20%) in patients with metastatic breast cancer are alopecia, 
neutropenia, sensory neuropathy, abnormal electrocardiogram (ECG), fatigue/asthenia, 
myalgia/arthralgia, aspartate aminotransferase (AST) elevation, alkaline phosphatase elevation, 
anemia, nausea, infections, and diarrhea {Abraxane® 2008, Abraxane® 2005 }. Nab-paclitaxel 
is contraindicated in patients who have neutrophil counts less than 1500 cells/mm³ and carries a 
black box warning. Nab-paclitaxel is also contraindicated in patients with severe hypersensitivity 
reaction to the drug. Nab-paclitaxel causes myelosuppression, sensory neuropathy, severe 
hypersensitivity reactions, and potential fetal harm.
Nab-paclitaxel is approved as monotherapy in metastatic breast cancer and in combination with 
atezolizumab in mTNBC for patients whose tumors express PD-L1. As a monotherapy, 
nab-paclitaxel was compared to paclitaxel in a randomized Phase 3 study in metastatic breast 
cancer patients who had failed combination chemotherapy or relapsed within 6 months of 
adjuvant chemotherapy. Nab-paclitaxel had a statistically significantly higher ORR of 21.5% 
compared to 11.1% for control {Abraxane® 2008, Abraxane® 2005 }. There was no statistically 
significant difference in OS between the 2 study arms.
The approval for 1L, PD-L1–positive TNBC was based on a randomized Phase 3 study 
evaluating atezolizumab + nab-paclitaxel versus placebo + nab-paclitaxel {Schmid 2018}. In 
451 patients, the median PFS was 7.2 months with atezolizumab + nab-paclitaxel, as compared 
with 5.5 months with placebo + nab-paclitaxel (P = 0.002). Among patients with PD-L1–positive 
tumors, the median PFS was 7.5 months and 5.0 months for experimental and control arms, 
respectively (HR: 0.62; P < 0.001). These data formed the basis for the approval of 
nab-paclitaxel + atezolizumab in PD-L1-positive mTNBC in the European Union (EU) in 
August 2019.
1.3.2.
Description of Paclitaxel
Paclitaxel, sold under the brand name Taxol® among others, is a natural product (obtained via a 
semisynthetic process from the Pacific yew tree [Taxus brevifolia]) with antitumor activity. It 
promotes the assembly and stabilization of microtubules, while inhibiting their depolymerization, 
and thus results in inhibition of mitosis and cell death. Common side effects include nausea and 
vomiting, loss of appetite, neutropenia, alopecia, anemia, arthralgia/myalgia, diarrhea, 
leukopenia, opportunistic infections, peripheral neuropathy, thrombocytopenia, mucositis, 
hypersensitivity, renal impairment, and hypotension. Dexamethasone is usually administered 
prior to paclitaxel infusion to mitigate some of the side effects.

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1.3.2.1.
Clinical Data for Paclitaxel
In the US, paclitaxel is approved for the adjuvant treatment of node-positive breast cancer 
administered sequentially to standard doxorubicin-containing combination chemotherapy; it is 
also approved as single-agent for the treatment of metastatic breast cancer (mBC) after failure of 
combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant 
chemotherapy. Approval was based on a Phase 3 study of 2 different doses (175 mg/m2 versus 
135 mg/m2) of Cremophor EL-dissolved paclitaxel given every 3 weeks in patients with mBC 
whose disease had progressed on or after previous chemotherapy {Nabholtz 1996}. Compared to 
the lower dose, the higher dose was associated with a longer median time to disease progression 
(4.2 versus 3.0 months, respectively; P = 0.027) and a longer median OS (11.7 versus 
10.5 months, respectively; P = 0.321). In the EU, paclitaxel is approved as monotherapy for late 
mBC and in combination with bevacizumab as 1L treatment.
The combination of pembrolizumab with a choice of chemotherapy (paclitaxel, nab-paclitaxel, or 
gemcitabine/carboplatin) received approval by the FDA based on the results of the KEYNOTE 
355 study for the treatment of patients with locally recurrent unresectable or metastatic TNBC 
whose tumors express PD-L1 (CPS at least 10) as determined by an FDA-approved test.
1.3.3.
Description of Sacituzumab Govitecan
Sacituzumab govitecan sold under the brand name Trodelvy® is an antibody-drug conjugate 
composed of 3 compounds: a humanized monoclonal antibody, a topoisomerase I inhibitor, and 
linker protein. It binds to Trop-2 expressing cells, forming an internalized complex that releases 
SN-38 intracellularly. SN-38 binds to topoisomerase I-DNA complexes, causing DNA damage 
and apoptosis. Common side effects include nausea, vomiting, diarrhea, neutropenia, anemia, 
fatigue, alopecia, constipation, decreased appetite, leukopenia, hyperglycemia, and 
hypomagnesemia {Bardia 2017}.
1.3.3.1.
Clinical Data for Sacituzumab Govitecan
Sacituzumab govitecan is approved in several countries, including the US, Canada, EU, and 
Australia, for the treatment of unresectable locally advanced or mTNBC. Approval for TNBC 
was based on the ASCENT protocol, a Phase 3, multicenter study with 468 patients with 
relapsed/refractory TNBC {Bardia 2021}. Patients were randomly assigned to receive 
sacituzumab govitecan (235 patients) or chemotherapy (233 patients). The median age was 
54 years, all patients were previously treated with taxanes and had no brain metastases. 
Sacituzumab govitecan was dosed at 10 mg/kg on Days 1 and 8 every 21 days until progression 
or unacceptable toxicity. Sacituzumab govitecan demonstrated a longer median PFS (5.6 vs 
1.7 months), and longer median OS (12.1 vs 6.7 months) than the chemotherapy arm. The 
percentage of patients with an objective response was 35% with sacituzumab govitecan and 5% 
with chemotherapy. The incidences of key treatment-related AEs of Grade 3 or higher were 
neutropenia (51% with sacituzumab govitecan and 33% with chemotherapy), leukopenia (10% 
and 5%), diarrhea (10% and < 1%), anemia (8% and 5%), and febrile neutropenia (6% and 2%). 
There were 3 deaths owing to AEs in each group; no deaths were considered to be related to 
sacituzumab govitecan treatment.

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1.4.
Rationale for Cohort 1
Strong nonclinical and clinical rationale exists for combining magrolimab with chemotherapy 
agents, including taxanes. Chemotherapeutic agents have been demonstrated to enhance 
prophagocytic signals on tumor cells, which leads to synergistic antitumor activity when 
combined with magrolimab, a CD47-targeting antibody that blocks the antiphagocytic signal. 
Simultaneous blockade of the antiphagocytic signal CD47 by magrolimab with upregulation of 
prophagocytic signals via chemotherapies can lead to synergistic phagocytosis of tumor cells by 
macrophages. Indeed, magrolimab combination with taxanes (paclitaxel) led to enhanced 
phagocytosis of solid tumor cells in vitro and a statistically significant reduction and elimination 
of ovarian cancers in vivo when compared to single-agent therapy {Sikic 2016}. Clinically, 
magrolimab has been combined with cytotoxic agents and chemotherapy (including azacitidine, 
gemcitabine, and oxaliplatin) in hematologic malignancies including AML, MDS, and NHL. 
These agents also upregulate prophagocytic signals and have led to enhanced combination 
activity with magrolimab in nonclinical models. In the clinical setting, magrolimab and 
azacitidine have led to a 91% ORR in patients with untreated higher-risk MDS and a 64% ORR 
in untreated AML patients {Sallman 2020}. Combination efficacy also has been observed with 
magrolimab in combination with chemotherapeutic agents (gemcitabine, oxaliplatin, and 
rituximab) in patients with r/r DLBCL. Importantly, the addition of magrolimab to these 
cytotoxic/chemotherapeutic agents did not generally exacerbate toxicities and the combination 
had an acceptable safety profile, with no MTD reached (Section 1.2.3.3).
Patients with newly diagnosed mTNBC are generally treated with either taxane-based 
chemotherapy or an immune checkpoint inhibitor (atezolizumab) in combination with taxane for 
those patients whose tumors express PD-L1. While the recent approval of atezolizumab + 
nab-paclitaxel has improved PFS in the frontline mTNBC setting, this effect was most 
pronounced in those patients whose tumors were PD-L1 positive. These results led to the 
approval of atezolizumab in combination with nab-paclitaxel in PD-L1–positive mTNBC 
patients. Additional immune checkpoint inhibitors combined with taxane therapy are also being 
evaluated in the frontline mTNBC setting. Despite these advances, single-agent taxane therapy 
remains a standard for newly diagnosed mTNBC patients whose tumors are PD-L1 negative. 
PD-L1–negative mTNBC is seen in approximately 35% to 60% of patients {Marra 2019}. 
Outcomes with single-agent taxane therapy in mTNBC remain suboptimal, with response rates 
approximately 30%, PFS around 5 months, and OS around 12 to 18 months {Kim 2017, Schmid 
2018, Tutt 2018}. Thus, novel regimens that can safely and effectively be combined with taxanes 
are needed to improve the clinical benefit in PD-L1–negative frontline mTNBC patients. Strong 
nonclinical and clinical data support the evaluation of magrolimab in combination with 
chemotherapy, including taxanes, in patients with newly diagnosed mTNBC.
The objective of this Phase 2 study cohort is to evaluate the safety, tolerability, and 
recommended Phase 2 dose (RP2D) of magrolimab in combination with nab-paclitaxel or 
paclitaxel in patients previously untreated for unresectable, locally advanced or metastatic TNBC 
whose tumors are not appropriate for immune checkpoint inhibitor therapy. In the randomized 
portion, the efficacy and safety of magrolimab in combination with the choice of nab-paclitaxel 
or paclitaxel will be compared against nab-paclitaxel or paclitaxel in the same patient population. 

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In this study, 2 combination regimens will be investigated, namely magrolimab + nab-paclitaxel 
and magrolimab + paclitaxel. Nab-paclitaxel or paclitaxel have been selected as the combination 
partners for magrolimab and comparator given their lack of significant overlapping toxicities 
with magrolimab and their common use in mTNBC, including recent data in combination with 
pembrolizumab and atezolizumab. This approach allows for the inclusion of the most commonly 
used single-agent chemotherapy class (taxanes). The rationale for allowing for the choice of 
either nab-paclitaxel and paclitaxel accounts for variability in availability of the 2 agents across 
the globe, clinical use worldwide, as well as generally comparable benefit observed in terms of 
PFS in the recent 1L TNBC studies (KEYNOTE 355 and IMpassion130).
In summary, a strong nonclinical and clinical rationale exists for evaluating a combination of 
magrolimab and nab-paclitaxel or paclitaxel in untreated mTNBC patients.
1.4.1.
Rationale for Cohort 2
Overexpression of CD47 has been reported in TNBC and is a poor prognostic factor for 
disease-free survival {Yuan 2019}. Additionally, there are data to suggest that CD47 is 
upregulated in chemotherapy-treated TNBC cells indicating that CD47 is an ideal target to treat 
drug-resistant or chemotherapy-treated TNBCs {Si 2021}. Although sacituzumab govitecan has 
demonstrated a significant increase in PFS in heavily pretreated patients with TNBC when 
compared to standard-of-care therapy, there is still room for additional improvement for patients 
who fail initial treatment for advanced TNBC. Sacituzumab govitecan was developed to treat 
cancers by binding to Trop-2 for targeted delivery of SN-38 directly to the tumor cell while 
minimizing systemic exposure of SN-38 to decrease host toxicity. The Trop-2 antigen is highly 
expressed on most solid epithelial cancers, including TNBC. Sacituzumab govitecan causes 
DNA damage and apoptosis, which can serve as the second pro-apoptotic signal needed in tumor 
cells exposed to magrolimab. We believe that the addition of magrolimab to sacituzumab 
govitecan will have an added antitumor effect due to the expression of CD47 and Trop-2 on 
TNBC tumor cells without a significant increase in toxicity due to nonoverlapping safety profiles 
(Section 1.6).
1.5.
Rationale for Dose Selection of Magrolimab
The rationale for the magrolimab dose proposed in this study originates from safety, efficacy, 
and PK/pharmacodynamics (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 (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 

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magrolimab {Advani 2018, Liu 2015a, Sikic 2019}. Based on PK-PD modeling, a maintenance 
dose of 30 mg/kg every 2 weeks is expected to provide more than 90% occupancy of the CD47 
receptor in peripheral blood and tumor tissues and thus is expected to provide maximal efficacy 
while maintaining adequate safety. In solid tumors where the combination therapy 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 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 Study 5F9005 showed that the 
magrolimab dose of 45 mg/kg every 3 weeks was suboptimal compared to 30 mg/kg every 
2 weeks and 60 mg/kg every 3 weeks dosing in maintaining 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 
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.
1.5.1.
Safety Run-in Cohorts 1 and 2 and Phase 2 Cohorts 1 and 2
The following magrolimab dosing regimen is proposed for Safety Run-in Cohort 1 and Phase 2 
Cohort 1 over a 28-day cycle:
•
Cycle 1: priming (1 mg/kg) on Day 1 and 30 mg/kg on Days 8, 15, and 22
•
Cycle 2: weekly doses of 30 mg/kg on Days 1, 8, 15, and 22
•
Cycle 3 and onward: 30 mg/kg on Days 1 and 15
The following magrolimab dosing regimen is proposed for Safety Run-in Cohort 2 and Phase 2 
Cohort 2 over a 21-day cycle:
•
Cycle 1: priming (1 mg/kg) on Day 1 and 30 mg/kg on Days 8 and 15
•
Cycle 2: weekly doses of 30 mg/kg on Days 1, 8, and 15
•
Cycle 3 and onward: 60 mg/kg on Day 1
1.6.
Risk/Benefit Assessment for the Study
Patients with metastatic solid tumors who fail frontline combination chemotherapy and/or 
immune checkpoint inhibitor therapy have limited treatment options with a poor prognosis. In 
general, single-agent chemotherapy (ie, taxanes) are utilized in this setting across several solid 
tumor types. However, response rates are approximately 10%, with a limited median OS. Thus, 
novel therapies that can be safely combined with chemotherapy to enhance efficacy are needed 
in this high-unmet-need patient setting. Patients with newly diagnosed mTNBC whose tumors 

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are PD-L1–negative are treated with single-agent taxane therapy. However, prognosis is limited, 
with a median PFS of approximately 5 months. As in the relapsed solid tumor setting, novel 
agents that can be combined safely with taxanes to enhance efficacy are needed to improve 
patient outcomes in PD-L1–negative mTNBC.
Magrolimab can eliminate tumor cells through macrophage-mediated phagocytosis. Magrolimab 
activity can be enhanced with chemotherapeutic agents that can increase prophagocytic signals 
on tumor cells, leading to synergistic phagocytosis. Nonclinical data have shown that 
magrolimab in combination with taxanes leads to enhanced phagocytosis of solid tumor cells in 
vitro and prolonged remissions in xenograft models compared to single-agent therapy. 
Furthermore, clinical study data has shown that magrolimab can enhance the efficacy of 
cytotoxic agents including an over 90% ORR in patients with newly diagnosed, higher-risk MDS 
with magrolimab in combination with azacitidine {Sallman 2020}. A combination study with 
magrolimab and traditional chemotherapy (gemcitabine, oxaliplatin, and rituximab) is ongoing in 
patients with NHL that has also shown initial signs of activity and an acceptable safety profile. 
Thus, the scientific rationale, nonclinical, and clinical data support a combination of magrolimab 
with taxane chemotherapy, including nab-paclitaxel or paclitaxel.
Treatment with the proposed combination of magrolimab and nab-paclitaxel or paclitaxel for 
mTNBC is not anticipated to pose a significantly increased risk to patients enrolled in this study 
compared to the risk of treatment with the agents alone. Based on the clinical profiles of 
magrolimab, nab-paclitaxel, and paclitaxel, overlapping toxicities (except for potential anemia 
and neutropenia) are not anticipated with the combination. While magrolimab does cause a 
transient, generally mild to moderate anemia, nab-paclitaxel, paclitaxel, and sacituzumab 
govitecan generally induces Grade 1 or 2 anemia in patients. Potential anemia observed is 
managed by a priming/maintenance dose regimen for magrolimab, frequent laboratory 
monitoring of blood counts, and RBC transfusion guidance. Importantly, magrolimab does not 
cause overlapping toxicities that are significant to nab-paclitaxel or paclitaxel, including 
hepatotoxicity or neurological toxicities. Specific clinical and laboratory monitoring of 
magrolimab-, nab-paclitaxel-, and paclitaxel-related toxicities will be implemented in this study. 
Furthermore, magrolimab has been combined with cytotoxic chemotherapy (gemcitabine, 
oxaliplatin, and rituximab in NHL patients) without observation of exacerbation of 
chemotherapy toxicities, with an acceptable safety profile, and with no MTD reached. Thus, the 
anticipated safety profile of magrolimab with taxane combinations represent an acceptable 
risk-benefit ratio to patients.
Magrolimab when given in combination with other chemotherapeutic agents in patients with 
solid tumors and hematologic malignancies has shown promising activity. Sacituzumab 
govitecan has been approved in several countries for the treatment of advanced TNBC based on 
the significant improvement in PFS and OS as compared to standard-of-care therapy. As 
demonstrated by other chemotherapeutic agents, sacituzumab govitecan may enhance the 
prophagocytic signals on tumor cells producing synergistic activity when combined with 
magrolimab. The addition of magrolimab can potentially improve the established activity of 
sacituzumab govitecan in patients with unresectable locally advanced or mTNBC. 

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The safety profile of magrolimab in combination with sacituzumab govitecan is also expected to 
be acceptable. As described in Section 1.3.3.1, key Grade 3 or higher treatment-related AEs for 
sacituzumab govitecan were neutropenia, leukopenia, diarrhea, anemia, and febrile neutropenia. 
Based on the clinical profiles of magrolimab and sacituzumab govitecan, significant overlapping 
toxicities (except for anemia and potentially diarrhea) are not anticipated with the combination. 
While magrolimab has been associated with diarrhea, the vast majority of these events have been 
Grade 1 or 2 in severity. Therefore, the anticipated safety profile of magrolimab in combination 
with sacituzumab govitecan represents an acceptable risk-benefit ratio to patients.
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 a strong scientific rationale, nonclinical and emerging clinical data, 
limited overlapping toxicities, and the risk mitigation measures being implemented for the 
pandemic, the evaluation of magrolimab in combination with nab-paclitaxel or paclitaxel or 
sacituzumab govitecan in patients with mTNBC is anticipated to have an acceptable risk-benefit 
ratio to the patients enrolled in this study.
1.7.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice, and all 
applicable regulatory requirements.

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2.
OBJECTIVES AND ENDPOINTS
Table 1 presents the study objectives and endpoints. The analysis of the endpoints is described in 
Section 8.
Table 1.
Study Objectives and Endpoints
Primary Objectives
Primary Endpoints
Safety Run-in Cohort 1:
•
To evaluate the safety, tolerability, and RP2D 
of magrolimab in combination with nab-
paclitaxel or paclitaxel
Phase 2 Cohort 1:
•
To compare the efficacy of magrolimab in 
combination with nab-paclitaxel or paclitaxel 
versus nab-paclitaxel or paclitaxel alone as 
determined by progression-free survival (PFS) 
by investigator assessment
Safety Run-in Cohort 2:
•
To evaluate the safety, tolerability, and RP2D 
of magrolimab in combination with 
sacituzumab govitecan
Cohort 2 (Safety Run-in Cohort 2 and Phase 2 
Cohort 2):
•
To evaluate the efficacy of magrolimab in 
combination with sacituzumab govitecan as 
determined by confirmed ORR by investigator 
assessment
Safety Run-in Cohorts 1 and 2:
•
Incidence of dose-limiting toxicities (DLTs), AEs, 
and laboratory abnormalities according to National 
Cancer Institute (NCI) Common Terminology Criteria 
for Adverse Events (CTCAE), Version 5.0 
Phase 2 Cohort 1:
•
PFS, defined as the time from the date of 
randomization until the earliest date of documented 
disease progression as determined by investigator 
assessment using RECIST, Version 1.1, or death from 
any cause, whichever occurs first
Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2):
•
Confirmed ORR (defined as the proportion of patients 
who achieve complete response or partial response 
that is confirmed at least 4 weeks after initial 
documentation of response), as determined by 
investigator assessment per RECIST, Version 1.1
Secondary Objectives
Secondary Endpoints
Phase 2 Cohort 1:
•
To compare the efficacy between treatment 
arms by ORR by investigator assessment 
•
To compare the efficacy between treatment 
arms by additional measures of efficacy, 
including DOR and OS
•
To compare the safety and tolerability between 
treatment arms
Cohort 2 (Safety Run-in Cohort 2 and Phase 2 
Cohort 2): 
•
To evaluate PFS by investigator assessment
•
To evaluate additional measures of efficacy of 
magrolimab in combination with sacituzumab 
govitecan, including DOR and OS
•
Safety and tolerability of magrolimab in 
combination with sacituzumab govitecan
Phase 2 Cohort 1 and Cohort 2 (Safety Run-in Cohort 2 
and Phase 2 Cohort 2):
•
Confirmed ORR, as determined by investigator 
assessment per RECIST, Version 1.1 (only for 
Phase 2 Cohort 1)
•
PFS, as determined by investigator assessment per 
RECIST, Version 1.1, or death from any cause, 
whichever occurs first (only for Cohort 2)
•
DOR, defined as time from first documentation of 
complete response or partial response to the earliest 
date of documented disease progression as determined 
by investigator assessment, per RECIST, Version 1.1, 
or death from any cause, whichever occurs first 
•
OS, defined as time from date of randomization to 
death from any cause
•
Incidence of AEs and laboratory abnormalities 
according to NCI CTCAE, Version 5.0

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Safety Run-in Cohorts 1 and 2 and Phase 2 
Cohorts 1 and 2:
•
To evaluate the pharmacokinetics (PK) and 
immunogenicity of magrolimab in combination 
with anticancer chemotherapies
Safety Run-in Cohorts 1 and 2 and Phase 2 Cohorts 1 
and 2:
•
Magrolimab concentration versus time and ADA to 
magrolimab 
CCI

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3.
STUDY DESIGN
3.1.
Study Design
This is a Phase 2, randomized (Phase 2 Cohort 1 only), open-label, multicenter study to evaluate 
magrolimab in combination with either nab-paclitaxel or paclitaxel for patients with untreated, 
unresectable, locally advanced or mTNBC and magrolimab in combination with sacituzumab 
govitecan for patients with unresectable, locally advanced or metastatic TNBC who have 
received at least 1 and no more than 2 prior lines of treatment in the unresectable, locally 
advanced or metastatic setting. This study will consist of 2 Safety Run-in Cohorts:
•
Safety Run-in Cohort 1: magrolimab in combination with the choice of nab‑paclitaxel or 
paclitaxel administered in patients previously untreated for unresectable, locally advanced or 
mTNBC whose tumors are not appropriate for immune checkpoint inhibitor therapy.
•
Safety Run-in Cohort 2: magrolimab in combination with sacituzumab govitecan in patients 
with unresectable, locally advanced or mTNBC who have received at least 1 and no more 
than 2 prior lines of treatment in the unresectable, locally advanced or metastatic setting.
Once the safety review team (SRT) reviews each Safety Run-in Cohort and the sponsor 
determines the RP2D for that cohort, Phase 2 cohorts 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 the first dose of study treatment, during 
which time the patient’s eligibility and baseline characteristics will be determined. Assessments 
performed as part of standard of care prior to informed consent form (ICF) signature may be 
used if they are within the required screening period. Patients will receive study treatment 
according to the dose schedule in Appendix Table 1 and Appendix Table 2.
The study schematic is presented in Figure 2.

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Figure 2.
Study Schema
mTNBC = metastatic triple-negative breast cancer; N = number of patients; R = ratio; RP2D = recommended Phase 2 dose 
3.1.1.
Safety Run-in Cohorts
Initially, up to 6 patients will be enrolled in Safety Run-in Cohort 1 at a starting dose level. A 
DLT evaluation period of 1 cycle (28 days) will occur.
Safety Run-in Cohort 2 will enroll up to 6 patients at a starting dose level. A DLT evaluation 
period of 1 cycle (21 days) will occur.
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. 
Cohorts 1 and 2 dose de-escalation decisions will be made as follows:
•
If 2 or less of 6 DLT-evaluable patients experience a DLT in Cycle 1, enrollment into 
Phase 2 Cohort 1 or Phase 2 Cohort 2 may begin at this dose level as the RP2D.
•
If more than 2 patients experience at least one DLT during Cycle 1, enrollment at the current 
dose level will immediately stop and dose de-escalation will occur. Approximately another 
6 patients will then be enrolled and evaluated at a lower dose level in the same manner.
Untreated 
unresectable locally 
advanced or mTNBC 
patients who are not 
eligible for immune 
check point inhibitors 
Unresectable locally 
advanced or mTNBC 
patients who have 
received one prior 
line of treatment in 
the unresectable 
locally advanced or 
metastatic setting 
Safety Run-in Cohort 1 
N=6-18 
Magrolimab 
+ Nab-paclitaxel 
or Paclitaxel - ~ 
Safety Run-in Cohort 2 
N=6-18 
Magrolimab 
+ sacituzumab 
govitecan 
Phase 2 Cohort 1 
N=28 
Arm A: 
Magrolimab + 
Nab-paclitaxel or Paclitaxel 
N=14 
;================= 
Arm B: 
Nab-paclitaxel 
or Paclitaxel 
N=14 
Phase 2 Cohort 2 
N=40 
Magrolimab + 
sacituzumab govitecan 
N=40 

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Approximately 18 patients (each cohort) could be potentially enrolled and evaluated during the 
Safety Run-in Cohorts.
Dose de-escalation for the Safety Run-in Cohorts is presented in Table 4 and Table 6. Based on 
the totality of the data, alternative doses of magrolimab not described in Table 4 or Table 6 may 
be considered by the SRT and sponsor.
3.1.1.1.
DLT Assessment Period
DLT Assessment Period for Safety Run-in Cohort 1: The DLT assessment period will be the 
first cycle (28 days). Patients are considered evaluable for assessment of a DLT if either of the 
following criteria are met in the DLT assessment period:
•
The patient experienced a DLT at any time after initiation of the first infusion of magrolimab.
•
The patient did not experience a DLT and completed at least 3 infusions of magrolimab 
(28-day cycle), and at least 2 doses of nab-paclitaxel or paclitaxel in Safety Run-in Cohort 1.
DLT Assessment Period for Safety Run-in Cohort 2: The DLT assessment period will be the 
first cycle (21 days). Patients are considered evaluable for assessment of a DLT if either of the 
following criteria are met in the DLT assessment period:
•
The patient experienced a DLT at any time after initiation of the first infusion of magrolimab.
•
The patient did not experience a DLT and completed at least 2 infusions of magrolimab 
(21-day cycle), and at least 2 infusions of sacituzumab govitecan in Safety Run-in Cohort 2.
If a patient experiences a DLT during the DLT assessment period, the patient will discontinue 
treatment. Though the dosing during maintenance cycles is higher, the total dose given during 
the priming cycle is higher than the maintenance dose. However, the totality of the data on safety 
during a longer follow-up will be taken into consideration when RP2D is determined.
Patients who are not evaluable for DLT assessment in the Safety Run-in Cohorts will be 
replaced.
3.1.1.2.
DLT Definition
All toxicities will be graded according to the NCI CTCAE, Version 5.0 (Appendix 4). 
A DLT is defined as any:
•
Grade 3 or higher hematologic toxicity including
Grade 3 hemolytic anemia that is medically significant, requiring hospitalization or 
prolongation of existing hospitalization, disabling, or limiting self-care activities of daily 
life.

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•
Event meeting Hy’s Law criteria (Section 7.7).
•
Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment 
baseline during the DLT assessment period, and in the opinion of the investigator, the AE is 
at least possibly related to magrolimab. 
The following are exceptions to the DLT definition and are NOT considered a DLT:
•
Grade 3 anemia; however, Grade 3 hemolytic anemia that is medically significant is 
considered a DLT (see above).
•
Grade 3 febrile neutropenia that has responded clinically within 72 hours of maximal 
supportive care.
•
Grade 3 neutropenia that resolves to Grade 2 or pretreatment baseline with supportive care 
(including growth factors) within 21 days or Grade 4 neutropenia lasting for 7 days or less 
with supportive measures.
•
Grade 3 thrombocytopenia in the absence of clinically significant bleeding that resolves to 
Grade 2 or pretreatment/baseline within 21 days.
•
Grade 3 indirect/unconjugated hyperbilirubinemia that resolves to Grade 2 or lower with 
supportive care within 1 week and is not associated with other clinically significant 
consequences.
•
Grade 3 electrolyte abnormalities that improve to Grade 2 or lower or baseline within 
72 hours, are not clinically complicated, and resolve spontaneously or respond to 
conventional medical interventions.
•
Grade 3 transaminase elevations characterized by increases of more than 5 to less than 
8 times the upper limit of normal (ULN) for AST and/or alanine aminotransferase (ALT). A 
Grade 3 transaminase elevation should meet DLT criteria for increases of more than 8 ULN 
for AST/ALT lasting less than 7 days. Grade 3 elevation in alkaline phosphatase that resolves 
to Grade 2 or lower with supportive care within 1 week and is not associated with other 
clinically significant consequences.
•
Grade 3 nausea/vomiting, or diarrhea that resolves to Grade 2 or lower within 72 hours with 
adequate antiemetic and other supportive care.
•
Grade 3 fatigue that resolves to Grade 2 or lower within 1 week on study.
•
Grade 3 magrolimab, nab-paclitaxel, paclitaxel, and sacituzumab govitecan IRRs in the 
absence of an optimal pretreatment regimen as defined in Section 7.8.1.3.
•
Grade 3 tumor lysis syndrome or electrolyte disturbances (hyperkalemia, hypophosphatemia, 
hyperuricemia) that resolve to Grade 2 or lower or baseline within 72 hours.

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•
Grade 3 hypomagnesemia that resolves to Grade 2 or lower within 1 week.
•
Grade 3 or 4 lymphopenia or leukopenia not associated with other clinically significant 
consequences.
•
Transient (less than or equal to 48 hours) Grade 3 local reactions, flu-like symptoms, 
myalgias, fever, headache, acute pain, or skin toxicity that resolves to Grade 2 or lower 
within 72 hours after medical management (eg, supportive care, including 
immunosuppressant treatment) has been initiated.
The recommended dose for Phase 2 Cohort 1 and Phase 2 Cohort 2 will be determined by the 
sponsor based on all relevant clinical and PK data from all patients treated in the Safety Run-in 
phase.
3.1.1.3.
Safety Review Team
An SRT will be established to assess safety of the patients.
The SRT will include at least 1 investigator, a Gilead safety physician, and the Gilead medical 
monitor. Others may be invited to participate as members of the SRT if additional expertise is 
desired. 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 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
Phase 2 Cohort 1
Once Safety Run-in Cohort 1 is completed and the RP2D for magrolimab + nab-paclitaxel or 
paclitaxel is determined, the sponsor will open Phase 2 Cohort 1. In this open-label, randomized, 
2-arm cohort, unresectable, locally advanced or mTNBC patients will be randomized in a 1:1 
ratio to either magrolimab + nab-paclitaxel or paclitaxel (Experimental Arm A) or nab-paclitaxel 
or paclitaxel (Control Arm B).
The primary efficacy assessment will be investigator-assessed PFS. In the original study design, 
the primary analysis was to occur after 63 events; however, due to the early closure of Phase 2 
Cohort 1, the primary analysis will occur when every enrolled patient has a minimum of 6 
months follow-up. Stratification factors for randomization include the following:
•
Receipt versus nonreceipt of neoadjuvant and/or adjuvant taxane therapy.
•
Presence versus absence of liver metastases.
•
Treatment with nab-paclitaxel versus paclitaxel.

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Phase 2 Cohort 2
Once Safety Run-in Cohort 2 is completed and the RP2D for magrolimab + sacituzumab 
govitecan is determined, the sponsor will open enrollment in Phase 2 Cohort 2. In this open-label 
single-arm cohort, unresectable, locally advanced or mTNBC patients will receive magrolimab 
in combination with sacituzumab govitecan.
3.1.2.1.
Treatment-Related Toxicity Monitoring
Treatment-related toxicity will be monitored by a Gilead Data Review Committee (GDRC) at a 
preset frequency with the stopping boundary listed in Table 2 after the safety data of the first 
12 treated patients in Phase 2 Cohort 1 Arm A from at least 1 cycle of follow-up become 
available. From the original design where 46 patients were planned to be enrolled for Phase 2 
Cohort 2 Arm A, a second GDRC review was planned when safety data of 36 patients from the 
first 3 cycles of follow-up become available. Given the early closure of Phase 2 Cohort 1, a total 
of 14 patients have been enrolled for Phase 2 Cohort 2 Arm A; therefore, only the first GDRC at 
N = 12 will occur. The ongoing treatment will stop when the number of patients with either 
Grade 4 or 5 treatment-related treatment-emergent adverse events (TEAEs) or treatment-related 
deaths meet the criteria. Bayesian toxicity monitoring {Lee 2021} based on beta-binomial model 
was used to derive the boundaries. Noninformative prior distribution of Beta (0.5, 0.5) for the 
true toxicity rate (θ) of Grade 4 or 5 treatment-related TEAEs is used, and excessive toxicity can 
be claimed when 𝑃(𝜃 ≥ 0.18ǀ𝑛, 𝑟) ≥ 0.9. The ‘n’ and ‘r’ are the sample size and number of 
patients with specific events at the interim analysis for toxicity monitoring, respectively. 
Maximum toxicity rate was assumed at 18%, where the excessive toxicity can be claimed if the 
posterior probability of excessive toxicity is higher than or equal to threshold at 90%. The 
probabilities of early stopping are 2.6%, 15.5%, and 50.8% when the true rates are 10%, 18%, 
and 30%, respectively. Similarly, noninformative prior distribution of Beta (0.25, 0.25) for the 
true toxicity rate of treatment-related death is used with maximum toxicity rate and threshold 
assumed as 2.5% and 90%, respectively. The probabilities of early stopping are 0.6%, 3.5%, and 
11.8 % when the true rates are 1%, 2.5%, and 5%, respectively. For Phase 2 Cohort 2, treatment-
related toxicity will be monitored by GDRC at a preset frequency with stopping boundary listed 
in Table 3 after the first 10 patients are treated at the dose level for Phase 2 Cohort 2 for at least 
1 cycle of follow-up, and thereafter when safety data from 30 patients from the first 3 cycles of 
follow-up become available. Same prior distribution as above are assumed. For Grade 4 or 5 
treatment-related TEAEs, maximum toxicity rate and threshold are assumed as 40% and 90%, 
respectively. The probabilities of early stopping are 2.0%, 21.1%, and 73.1% when the true rates 
are 25%, 40%, and 55%, respectively. For treatment-related deaths, maximum toxicity rate and 
threshold are assumed as 2.5% and 90%, respectively. The probabilities of early stopping are 
0.7%, 5.2%, and 21.5% when the true rates are 1%, 2.5%, and 5% respectively.
Table 2.
Stopping Boundary Due to Toxicity (Phase 2 Cohort 1 Arm A)
N = 12
Grade 4 or 5 treatment-related TEAEs
≥ 4
Treatment-related deaths
≥ 2
TEAEs = treatment-emergent adverse events

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Table 3.
Stopping Boundary Due to Toxicity (Phase 2 Cohort 2)
N = 10
N = 30
Grade 4 or 5 treatment-related TEAEs
≥ 6
≥ 16
Treatment-related deaths
≥ 2
≥ 3
TEAEs = treatment-emergent adverse events
3.2.
Study Treatments
3.2.1.
Safety Run-in Cohort 1 and Phase 2 Cohort 1
Table 4 shows the study treatments for Safety Run-in Cohort 1 and Table 5 shows the study 
treatments for Phase 2 Cohort 1. The schedules of assessments are provided in Appendix Table 1 
and Appendix Table 3. Nab-paclitaxel or paclitaxel use will be per investigator discretion and in 
accordance with local guidelines and practices.
Table 4.
Safety Run-in Cohort 1: Dose Level, Schedule, and De-escalation
Dose Schedule (Cycles are 28 Days)
Drug
Dose Level
Cycle 1
Cycle 2
Cycle 3+
Magrolimab
Starting dose
30 mg/kg
1 mg/kg IV (3 h ± 30 min) on 
Day 1 (priming dose); 
30 mg/kg IV (2 h ± 30 min) on 
Days 8, 15, and 22
30 mg/kg IV 
(2 h ± 30 min) on 
Days 1, 8, 15, and 22
30 mg/kg IV 
(2 h ± 30 min) on 
Days 1 and 15
De-escalation
Level −1
20 mg/kg
1 mg/kg IV (3 h ± 30 min) on 
Day 1 (priming dose); 
20 mg/kg IV (2 h ± 30 min) on 
Days 8, 15, and 22
20 mg/kg IV 
(2 h ± 30 min) on 
Days 1, 8, 15, and 22
20 mg/kg IV 
(2 h ± 30 min) on 
Days 1 and 15
De-escalation
Level −2
15 mg/kg
1 mg/kg IV (3 h ± 30 min) on 
Day 1 (priming dose); 
15 mg/kg IV (2 h ± 30 min) on 
Days 8, 15, and 22
15 mg/kg IV 
(2 h ± 30 min) on 
Days 1, 8, 15, and 22
15 mg/kg IV 
(2 h ± 30 min) on 
Days 1 and 15
Nab-paclitaxel
100 mg/m2
100 mg/m2 IV on Days 1, 8, 
and 15
100 mg/m2 IV on 
Days 1, 8, and 15
100 mg/m2 IV on 
Days 1, 8, and 15
Paclitaxel
90 mg/m2
90 mg/m2 IV on Days 1, 8, 
and 15
90 mg/m2 IV on 
Days 1, 8, and 15
90 mg/m2 IV on 
Days 1, 8, and 15
IV = intravenous

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Table 5.
Phase 2 Cohort 1: Dose Level and Schedule
Dose Schedule (Cycles are 28 Days)
Drug
Cycle 1
Cycle 2
Cycle 3+
Magrolimab (Arm A only)
1 mg/kg IV (3 h ± 30 min)
Day 1 (priming dose)
Magrolimab (Arm A only)
RP2Da IV (2 h ± 30 min)
Days 8, 15, and 22
Days 1, 8, 15, and 22
Days 1 and 15
Nab-paclitaxel (Arms A and B)
100 mg/m2 IV
Days 1, 8, and 15
Days 1, 8, and 15
Days 1, 8, and 15
Paclitaxel (Arms A and B)
90 mg/m2 IV
Days 1, 8, and 15
Days 1, 8, and 15
Days 1, 8, and 15
IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in the Safety Run-in Cohort.
3.2.2.
Safety Run-in Cohort 2 and Phase 2 Cohort 2
Table 6 shows the study treatments for Safety Run-in Cohort 2 and Table 7 shows the study 
treatments for Phase 2 Cohort 2. The schedules of assessments are provided in Appendix Table 2 
and Appendix Table 3. 
Table 6.
Safety Run-in Cohort 2: Dose Level, Schedule, and De-escalation
Dose Schedule (Cycles are 21 Days)
Drug
Dose Level
Cycle 1
Cycle 2
Cycle 3+
Magrolimab
Starting dose
30 mg/kg
1 mg/kg IV (3 h ± 30 min) 
on Day 1 (priming dose); 
30 mg/kg IV (2 h ± 30 min) 
on Days 8 and 15
30 mg/kg IV 
(2 h ± 30 min) on 
Days 1, 8, and 15
60 mg/kg IV 
(2 h ± 30 min) on 
Day 1
De-escalation
Level −1
20 mg/kg
1 mg/kg IV (3 h ± 30 min) 
on Day 1 (priming dose); 
20 mg/kg IV (2 h ± 30 min) 
on Days 8 and 15
20 mg/kg IV 
(2 h ± 30 min) on 
Days 1, 8, and 15
45 mg/kg IV 
(2 h ± 30 min) on 
Day 1
De-escalation
Level −2
15 mg/kg
1 mg/kg IV (3 h ± 30 min) 
on Day 1 (priming dose); 
15 mg/kg IV (2 h ± 30 min) 
on Days 8 and 15
15 mg/kg IV 
(2 h ± 30 min) on 
Days 1, 8, and 15
30 mg/kg IV 
(2 h ± 30 min) on 
Day 1
Sacituzumab 
govitecan
10 mg/kg
10 mg/kg IV (3 h ± 30 min) 
on Day 1 and 10 mg/kg IV 
(1 to 2 h ± 30 min) on Day 8
10 mg/kg IV (1 to 
2 h ± 30 min) on 
Days 1 and 8
10 mg/kg IV 
(1 to 2 h ± 30 min) 
on Days 1 and 8
IV = intravenous

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Table 7.
Phase 2 Cohort 2: Dose Level and Schedule
Dose Schedule (Cycles are 21 Days)
Drug
Cycle 1
Cycle 2
Cycle 3+
Magrolimab
1 mg/kg IV (3 h ± 30 min)
Day 1 (priming dose)
Magrolimab
RP2Da IV (2 h ± 30 min)
Days 8 and 15
Days 1, 8, and 15
Day 1
Sacituzumab govitecan
10 mg/kg IV
Day 1 
(3 h ± 15 min) and 
Day 8 
(1 to 2 h ± 30 min)
Days 1 and 8
(1 to 2 h ± 30 min)
Days 1 and 8
(1 to 2 h ± 30 min)
IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in the Safety Run-in Cohort.
For patients receiving magrolimab in combination with paclitaxel/nab-paclitaxel (Safety Run-in 
Cohort 1 and Cohort 1, Arm A) or sacituzumab govitecan (Safety Run-in Cohort 2 and 
Cohort 2), Cycle 1 Day 1 treatment can be administered over 2 days such that magrolimab is 
administered on Cycle 1 Day 1 and paclitaxel/nab-paclitaxel or sacituzumab govitecan on 
Cycle 1 Day 2. This also applies to repriming cycles that require Cycle 1 Day 1 dosing of 
magrolimab. Cycle 1 Day 1 dosing and infusion time requirements for each agent should be 
followed, as listed in Table 4, Table 5, Table 6, and Table 7. Premedication guidelines should be 
followed prior to magrolimab (see Section 5.8), paclitaxel/nab-paclitaxel (see Section 5.11), or 
sacituzumab govitecan (see Section 5.14). Patients should be observed during and following 
infusion for signs or symptoms of IRRs (see Section 5.6 for magrolimab, Section 5.10 for 
paclitaxel/nab-paclitaxel, and Section 5.13 for sacituzumab govitecan).
3.3.
Duration of Treatment
Cycle lengths are 28 days for Safety Run-in Cohort 1 and Phase 2 Cohort 1. Cycle lengths are 
21 days for Safety Run-in Cohort 2 and Phase 2 Cohort 2. Patients may continue treatment 
unless they develop unacceptable toxicity that cannot be clinically managed by dose or schedule 
modifications. 
If in the opinion of the investigator, the patient is deriving a clinical benefit, magrolimab, 
nab-paclitaxel, paclitaxel, or sacituzumab govitecan may be continued if the combination partner 
is discontinued due to unacceptable toxicity:
•
Magrolimab can be continued if nab-paclitaxel, paclitaxel, or sacituzumab govitecan is 
discontinued for unacceptable toxicity. 
•
Nab-paclitaxel, paclitaxel, or sacituzumab govitecan can be continued if magrolimab is 
discontinued for unacceptable toxicity. 
Patients who discontinue all study drugs will be followed for safety, disease progression, and 
survival.

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During the study, patients who meet criteria for disease progression per RECIST, Version 1.1, 
and show evidence of a clinical benefit may continue study drug treatment past the initial 
determination of disease progression, provided all of the following criteria are met:
•
No new symptoms or worsening of previous symptoms
•
Tolerance of study treatment
•
Stable Eastern Cooperative Oncology Group (ECOG) performance status
•
Treatment beyond progression will not delay an imminent intervention to prevent serious 
complications of disease progression (for example, CNS metastases)
The decision to continue treatment should be approved by the sponsor. Patients who continue 
study drug treatment past the initial determination of disease progression will be required to 
reconsent to the continued treatment.
3.4.
Discontinuation Criteria
Reasons for discontinuation of study treatment may include, but are not limited to, the following:
•
Disease progression (treatment beyond disease progression 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 [see Section 7.4.2.3] or other AEs)
•
Patients who permanently discontinue study drug for pregnancy should continue to have 
assessments for early discontinuation from the study performed (see Section 6.11); if there 
are any questions regarding permanent discontinuation, these should be discussed with the 
sponsor
•
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
Patients may continue study drug treatment beyond 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, 
and the end of study, whichever occurs first.
For any patient who dies during this follow-up period, the immediate cause of death must be 
reported to the sponsor.
3.6.
Poststudy Care
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), survival, and 
AEs as specified in Appendix Table 3.
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 indications studied, as well as the 
efficacy and MOA 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:
•
Blood sample for RO at select sites
•
Peripheral blood mononuclear cell (PBMC) to assess immune cell phenotypes (at select sites)

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• 
Sernm 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 assay 
• 
T-cell receptor sequencing sample to assess immune repertoire changes 
• 
Circulating tumor DNA sample to monitor treatment response 
• 
Stool samples to assess microbiome 
• 
Mandato1y baseline tumor tissue and on-treatment biopsies to assess immune cells, tumor 
cell-surface proteins, Trop-2 expression, and/or genomic biomarkers 
Blood and tumor biopsy samples will be collected to measure biomarkers, which may include 
but will not be liinited 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 
Inicroenvironment, and genetic mutations in tumor cells or subclones of tumor cells, at the time 
points listed in the schedule of assessments (Appendix Table 4). 
Blood and tumor samples will also be used for genomic research. In addition, a whole blood 
sample will be collected at Cycle 1 Day 1 but may be collected at any time during the study, if 
necessaiy. These samples will be used to identify or validate genetic mai·kers 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 diug absmption and disposition. These 
specimens may also be used to develop biomai·ker or diagnostic assays and establish the 
perfonnance chai·acteristics of these assays. Genoinics reseai·ch may include sequencing of 
genetic material derived from both cancer cells and nonnal cells. Sequencing of genetic material 
derived from cancer cells will be used to better understand the MOA 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 nonnal 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 countiy requirements. 
3.8.1. 
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4.
PATIENT POPULATION
4.1.
Number of Patients and Patient Selection
Approximately 104 patients may be enrolled in the study:
•
Safety Run-in Cohort 1: approximately 6 to 18 patients
•
Phase 2 Cohort 1: approximately 28 patients
•
Safety Run-in Cohort 2: approximately 6 to 18 patients
•
Phase 2 Cohort 2: approximately 40 patients
Patients enrolled in Cohort 1 Arm B with documented progressive disease can rescreen to enroll 
in Cohort 2 as long as they meet all other eligibility criteria.
4.1.1.
Patient Replacement
Patients may be replaced during the Safety Run-in Cohort if not evaluable for DLT assessment 
as described in Section 3.1.1.1.
4.2.
Inclusion Criteria
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, at least 18 years of age.
4) Patients must have an ECOG performance status of 0 or 1.
5) Laboratory measurements, blood counts:
a) Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment. RBC transfusions 
are allowed to meet hemoglobin eligibility within limits set per Exclusion Criterion #4 
(and per Section 7.8.1.2), except in South Korea.
b) Absolute neutrophil count (ANC) at least 1.5  109/L without growth factor support 
within 2 weeks of study treatment initiation.
c) Platelets at least 100  109/L.

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6) Laboratory measurements, renal function:
a) Patients must have adequate renal function as demonstrated by a creatinine clearance of 
at least 30 mL/min; calculated by the Cockcroft Gault formula.
7) Adequate liver function, as demonstrated by:
a) AST less than or equal to 2.5  ULN or less than or equal to 5  ULN in patients with 
liver metastases.
b) ALT less than or equal to 2.5  ULN or less than or equal to 5  ULN in patients with 
liver metastases.
c) Bilirubin less than or equal to 1.5  ULN, or less than or equal to 3.0  ULN and 
primarily unconjugated if patient has a documented history of Gilbert’s syndrome or 
genetic equivalent.
8) Pretreatment blood cross-match completed (Section 7.8.1.1).
9) 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.
10) Measurable disease according to RECIST, Version 1.1. Previously irradiated lesions can be 
considered as measurable disease only if disease progression has been unequivocally 
documented at that site since radiation.
11) Patients must have a life expectancy of 3 months or greater, in the opinion of the investigator.
Safety Run-in Cohort 1 and Phase 2 Cohort 1
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety 
Run-in Cohort 1 and Phase 2 Cohort 1 must fulfill the following cohort-specific inclusion 
criteria:
12) Patients previously untreated with systemic therapy for unresectable locally advanced or 
metastatic breast cancer and with a diagnosis of TNBC that is histologically or cytologically 
confirmed based on the most recent analyzed biopsy or other pathology specimen, defined as 
negative for estrogen receptor (ER), PR, and HER2 according to the most recent American 
Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guideline 
(Appendix 9). 
13) Patients whose tumors are considered PD-L1 negative, as determined by an approved test 
according to local standards.
14) Prior systemic treatment for neoadjuvant and/or adjuvant therapy and/or curative intent 
radiation therapy is permitted if completed at least 6 months prior to enrollment.
Note: Maintenance therapies are not counted as separate lines of therapy.

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Safety Run-in Cohort 2 and Phase 2 Cohort 2
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety 
Run-in Cohort 2 and Phase 2 Cohort 2 must fulfill the following cohort-specific inclusion 
criterion:
15) Patients with unresectable, locally advanced or metastatic breast cancer with a diagnosis of 
TNBC that is histologically or cytologically confirmed based on the most recent analyzed 
biopsy or other pathology specimen, defined as negative for ER, PR, and HER2 according to 
the most recent ASCO/CAP guideline (Appendix 9), who have received at least 1 and no 
more than 2 prior lines of systemic therapy in the unresectable, locally advanced/metastatic 
setting. Patients must have been previously treated with a taxane in the neoadjuvant, 
adjuvant, or locally advanced/metastatic setting. 
16) Patients with tumors considered positive for PD-L1 expression (as determined by an 
approved test according to local standards) must have received an immune checkpoint 
inhibitor for prior line of treatment for locally advanced/metastatic disease.
4.3.
Exclusion Criteria
Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
1) Positive serum pregnancy test.
2) Breastfeeding female.
3) Active CNS disease. Patients with asymptomatic and stable, treated CNS lesions who have 
been off steroids, radiation and/or surgery, and/or other CNS-directed therapy for at least 
4 weeks are allowed.
4) RBC 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 criteria, except in South Korea.
5) History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 
3 months.
6) Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
7) Prior treatment with CD47 or signal regulatory protein alpha-targeting agents.
8) Current participation in another interventional clinical study. Patients enrolled in a clinical 
study who are no longer receiving therapeutic intervention are eligible.
9) Known inherited or acquired bleeding disorders.

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10) 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. Additional information for sites in the 
United Kingdom (UK) is provided in Appendix 12. 
11) 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 2 years.
12) Known active or chronic hepatitis B or C infection or human immunodeficiency virus 
infection in medical history.
13) Uncontrolled pleural effusion. 
14) Uncontrolled hypercalcemia (Grade 2 or higher) or symptomatic hypercalcemia requiring 
continued use of bisphosphonate therapy.
15) Rapid deterioration during screening prior to enrollment (eg, significant change in 
performance status, 20% or greater decrease in serum albumin levels or uncontrolled 
tumor-related pain).
16) Severe/serious systemic infection within 4 weeks of randomization or any active, 
uncontrolled infection requiring systemic therapy within 7 days of enrollment. 
17) Other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be 
likely to confound study interpretation or prevent completion of study procedures and 
follow-up examinations.
18) Prior anticancer therapy within the specified timeframe prior to start of magrolimab is not 
permitted: 2 weeks for chemotherapy agents, endocrine therapy, or targeted small molecule 
therapy; 3 weeks for monoclonal antibodies, antibody-drug conjugates, immunotherapy, or 
investigational agents.
19) Patients who have received a live vaccine within 30 days of randomization.
Safety Run-in Cohort 1 and Phase 2 Cohort 1
Patients who meet the following exclusion criterion are not eligible to be enrolled into Safety 
Run-in Cohort 1 or Phase 2 Cohort 1:
20) Disease progression within 6 months following neoadjuvant/adjuvant therapy or prior lines 
of systemic therapy for unresectable locally advanced or metastatic breast cancer. 
NOTE: Localized non-CNS radiotherapy, hormonal therapy for breast cancer in the curative 
setting, and treatment with bisphosphonates and receptor activator of nuclear factor kappa B 
ligand inhibitors are not included in Exclusion Criterion #20. Patients should be recovered from 
the effects of radiation. Additional information for sites in the UK is provided in Appendix 12

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Safety Run-in Cohort 2 and Phase 2 Cohort 2
Patients who meet any of the following exclusion criteria are not eligible to be enrolled into 
Safety Run-in Cohort 2 or Phase 2 Cohort 2:
21) Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) 
and patients with a history of bowel obstruction or gastrointestinal perforation within 
6 months of enrollment.
22) Patients who previously received topoisomerase I inhibitors or antibody-drug conjugates 
containing a topoisomerase I inhibitor.
23) High-dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed 
within 2 weeks of Cycle 1 Day 1.
24) Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously 
administered agent.
Note: patients with any grade of neuropathy, alopecia, hypo- or hyperthyroidism, or other 
endocrinopathies that are well controlled with hormone replacement are an exception to 
this criterion and will qualify for the study.
Note: if patients received major surgery, they must have recovered adequately from the 
toxicity and/or complications from the intervention prior to starting therapy.
NOTE: Localized non-CNS radiotherapy is not criteria for exclusion. Patients should be 
recovered from the effects of radiation.

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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 who meet eligibility criteria will be randomized in a 1:1 ratio to 
magrolimab in combination with nab-paclitaxel or paclitaxel or either nab-paclitaxel or 
paclitaxel using IRT. Nab-paclitaxel or paclitaxel use will be per investigator discretion and in 
accordance with local guidelines and practices. The first dose on Day 1 must be within 3 days of 
randomization.
Randomization will be stratified by 1) receipt versus nonreceipt of neoadjuvant and/or adjuvant 
taxane therapy, 2) presence versus absence of liver metastases, and 3) treatment with 
nab-paclitaxel versus paclitaxel.
5.1.2.
Blinding
Blinding of treatment assignments or data will not be performed in this 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 by the sponsor 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, Medicinal Products for Human and Veterinary Use, Annex 13 
(Investigational Medicinal Products) for Clinical Trials Directive, or Annex 6 for Clinical Trials 
Regulation, as applicable, and/or other local regulations.
5.2.3.
Storage and Handling
Magrolimab should be stored at 2 °C to 8 °C (36 °F to 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.

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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.
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 Nab-paclitaxel
5.3.1.
Formulation
Nab-paclitaxel is commercially sourced. Information regarding the formulation can be found in 
the current local prescribing information.
5.3.2.
Packaging and Labeling
Commercial product of nab-paclitaxel will be used for this study. Study drug(s) to be distributed 
by the sponsor 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, 
Medicinal Products for Human and Veterinary Use, 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
Nab-paclitaxel is commercially sourced. Information regarding the storage and handling can be 
found in the current prescribing information.
5.4.
Description and Handling of Paclitaxel
5.4.1.
Formulation
Paclitaxel is commercially sourced. Information regarding the formulation can be found in the 
current local prescribing information.
5.4.2.
Packaging and Labeling
Commercial product of paclitaxel will be used for this study. Study drug(s) to be distributed by 
the sponsor 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, 
Medicinal Products for Human and Veterinary Use, 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.

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5.4.3.
Storage and Handling
Paclitaxel is commercially sourced. Information regarding the storage and handling can be found 
in the local prescribing information.
5.5.
Description and Handling of Sacituzumab Govitecan
5.5.1.
Formulation
Sacituzumab govitecan is supplied as a sterile, off-white to yellowish lyophilized powder in 
single-dose glass vials. It is formulated in 2-(N-morpholino) ethane sulfonic acid buffer 
containing trehalose and polysorbate 80 and contains no preservatives. Following reconstitution, 
the concentration of the study drug is 10 mg/mL. The pH of the reconstituted solution is 
approximately 6.5.
5.5.2.
Packaging and Labeling
Sacituzumab govitecan is packaged in single-use, 50R, glass vials, closed with coated 
elastomeric stoppers and capped with flip-off caps with aluminum overseals. Study drug(s) to be 
distributed by the sponsor 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, 
Medicinal Products for Human and Veterinary Use, Annex 13 (Investigational Medicinal 
Products), and/or other local regulations.
5.5.3.
Storage and Handling
Sacituzumab govitecan vials must be stored in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F) in 
the original carton to protect from light until time of reconstitution. Since the formulated drug 
product contains no preservative, the vials are single-use only. 
Refer to the current version of the Pharmacy Manual for additional details.
5.6.
Dosage and Administration of Magrolimab
Magrolimab should be administered as outlined in the Pharmacy Manual for the study. The dose 
of magrolimab will be calculated based on actual weight enrollment (using weight obtained 
either at screening or on Day 1) and will remain constant throughout the study unless there is a 
more than 10% change in weight from baseline. Modifications to the study drug doses 
administered should be made for a more than 10% change in body weight and/or according to 
local and regional prescribing standards. Dose modifications for changes in body weight less 
than 10% may be made according to local institutional guidelines.
The duration for 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 and every 2 weeks (Cohort 1) or 
every 3 weeks (Cohort 2) during Cycle 3 and beyond depending on the dose of magrolimab. 
Magrolimab doses are not to be given on consecutive days.
When magrolimab is given in combination with nab-paclitaxel, paclitaxel, or sacituzumab 
govitecan, magrolimab should 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 nab-paclitaxel, paclitaxel, 
or sacituzumab govitecan. Postinfusion monitoring is not required for doses after Cycle 1 
Day 22. 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 reporting requirements.
For patients receiving magrolimab in combination with paclitaxel/nab-paclitaxel (Safety Run-in 
Cohort 1 and Cohort 1, Arm A) or sacituzumab govitecan (Safety Run-in Cohort 2 and 
Cohort 2), Cycle 1 Day 1 treatment can be administered over 2 days such that magrolimab is 
administered on Cycle 1 Day 1 and paclitaxel/nab-paclitaxel or sacituzumab govitecan on 
Cycle 1 Day 2. This also applies to repriming cycles that require Cycle 1 Day 1 dosing of 
magrolimab. Cycle 1 Day 1 dosing and infusion time requirements for each agent should be 
followed, as listed in Table 4, Table 5, Table 6, and Table 7. Premedication guidelines should be 
followed prior to magrolimab (see Section 5.8), paclitaxel/nab-paclitaxel (see Section 5.11), or 
sacituzumab govitecan (see Section 5.14). Patients should be observed during and following the 
infusion for signs or symptoms of IRRs (see Section 5.10 for paclitaxel/nab-paclitaxel and 
Section 5.13 for sacituzumab govitecan).
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 in Section 3.4).
5.6.1.
Treatment Delay and Repriming for Magrolimab
Given the large CD47 antigen sink on normal cells, patients who have a long dose delay of 
magrolimab are required to be reprimed with magrolimab dosing to resaturate the CD47 antigen 
sink. Guidelines for repriming/re-escalation for magrolimab after a dose delay are provided in 
Section 5.7.
The magrolimab dosing regimens for each cohort are described in Table 4 (Safety Run-in 
Cohort 1), Table 5 (Phase 2 Cohort 1), Table 6 (Safety Run-in Cohort 2), and Table 7 
(Phase 2 Cohort 2).
5.7.
Dose Modifications, Delays, and Discontinuation for Magrolimab
In most circumstances, the dose of magrolimab should not be reduced except in the 
Safety Run-in Cohorts in the case of dose de-escalation based on DLTs. 

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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. 
Dose reduction of magrolimab may be allowed in certain circumstances (eg, with certain AEs), 
consultation with the sponsor is recommended prior to dose reductions of magrolimab.
When the combination drugs (nab-paclitaxel or paclitaxel or sacituzumab govitecan) are delayed 
due to toxicities, magrolimab should continue independently as per magrolimab administration 
schedule. Continuous dosing of magrolimab is needed to maintain efficacious exposures and 
optimal efficacy. During the maintenance phase (Cycle 3 onwards), if the last dose of 
magrolimab was administered within the previous 7 to 13 days (Cohort 1) or within the previous 
10 to 20 days (Cohort 2), the subsequent magrolimab dose may be administered earlier than 
scheduled in order to synchronize with the backbone chemotherapy administration.
Magrolimab should be withheld if treatment-emergent and/or related AEs occur. In the event of 
magrolimab delay, dosing should resume as soon as it is clinically appropriate and logistically 
possible, without waiting to align with the patient’s original treatment schedule.
The repriming guidelines shown in Table 8 (Safety Run-in Cohort 1 and Phase 2 Cohort 1) and 
in Table 9 (Safety Run-in Cohort 2 and Phase 2 Cohort 2) should be followed for patients with 
dose delays. During repriming, cycle numbering and efficacy, biomarker, PK, and 
immunogenicity assessments should continue according to the assigned cycle number. If 
repriming is required during Cycles 1 or 2, dosing frequency and safety assessments should 
follow Cycle 1, then Cycle 2, and begin maintenance from Cycle 3 onwards. If repriming is 
required during the maintenance phase (Cycle 3 onwards), dosing frequency and safety 
assessments should follow Cycle 1 and subsequent dosing should resume maintenance dosing at 
the next assigned cycle.
When magrolimab safety assessments and dosing schedule should follow the Cycle 1 
assessments, refer to Table 4 (Safety Run-in Cohort 1), Table 5 (Phase 2 Cohort 1), Table 6 
(Safety Run-in Cohort 2), and Table 7 (Phase 2 Cohort 2). When magrolimab safety assessments 
and dosing schedule are to be switched back to the next assigned cycle schedule, refer to 
Appendix Table 1 and Appendix Table 2. If repriming is required during Cycles 1 or 2, dosing 
frequency and safety assessments should follow Cycle 1, then Cycle 2, and begin maintenance 
from Cycle 3 onwards. If repriming is required during the maintenance phase (Cycle 3 onwards), 
magrolimab dosing frequency and safety assessments should follow Cycle 1 and subsequent 
dosing should resume maintenance dosing at the next assigned cycle.
Criteria for permanent discontinuation of magrolimab include the following:
•
Grade 4 IRR occurring with the first dose (priming dose)
•
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.

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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 (Safety Run-in Cohort 1 and 
Phase 2 Cohort 1)
Dose
Dosing Frequency
Minimum Duration of Treatment 
Gapa 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 2 weeks (from Cycle 3)
4 weeks
Weekly (during Cycles 1 and/or 2)
2 weeks
20 mg/kg
Every 2 weeks (from Cycle 3)
4 weeks
Weekly (during Cycles 1 and/or 2)
2 weeks
30 mg/kg
Every 2 weeks (from Cycle 3)
4 weeks
NA = not applicable
a
Repriming gap starts the day after the last dose of magrolimab and consists of the total consecutive days on which 
magrolimab is not administered.
Table 9.
Repriming Guidelines for Magrolimab (Safety Run-in Cohort 2 and 
Phase 2 Cohort 2)
Dose
Dosing Frequency
Minimum Duration of Treatment 
Gapa That Will Lead to 
Repriming
1 mg/kg
NA–used at initial priming
2 weeks
15 mg/kg
Weekly (during Cycles 1 and/or 2)
2 weeks
20 mg/kg
Weekly (during Cycles 1 and/or 2)
2 weeks
Weekly (during Cycles 1 and/or 2)
2 weeks
30 mg/kg
Every 3 weeks (from Cycle 3)
4 weeks
45 mg/kg
Every 3 weeks (from Cycle 3)
4 weeks
60 mg/kg
Every 3 weeks (from Cycle 3)
4 weeks
NA = not applicable
a
Repriming gap starts the day after the last dose of magrolimab and consists of the total consecutive days on which 
magrolimab is not administered.
If planned surgical procedures are needed for patients on study treatment, magrolimab will be 
delayed and restarted in accordance with Table 10.

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Table 10.
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
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
5.8.
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 should include oral acetaminophen 650 to 
1000 mg, oral or IV diphenhydramine 25 to 50 mg, and IV dexamethasone 4 to 20 mg, or 
comparable regimen. Premedication decisions during 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.
5.9.
Prior and Concomitant Medications
5.9.1.
Prior and Concomitant Medications With Magrolimab
5.9.1.1.
Permitted Concomitant Medications
Premedication and prophylaxis for AEs is permitted while on study treatment. Palliative and/or 
supportive medications, such as pain medications, bone-modifying medications (bisphosphonates 
or denosumab), antiemetics or antidiarrheal medications, and growth factor support are allowed 
at the investigator’s discretion. Palliative, localized non-CNS radiotherapy, is permitted to areas 
of nontarget disease on study; refer to Section 6.6 for the response assessment details regarding 
palliative radiotherapy allowed in this study. Corticosteroid use is permitted for symptomatic 
treatment, premedication, pseudoprogression, and/or specific patient conditions. Chronic 
high-dose steroid use is not recommended unless clinically indicated. Red blood cell and platelet 
transfusions 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 all 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 should be recorded in the eCRF. Only the drug name, 
indication, route, and dates of concomitant medications will be captured in the eCRF.

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5.9.1.2.
Coronavirus Disease 2019 (COVID-19) Vaccine
There is no contraindication to the COVID-19 vaccine with magrolimab. There is no specific 
recommendation on the timing of a COVID-19 vaccine; individuals may receive the vaccine 
when available. However, if these patients are neutropenic, investigators may use local guidance 
as well as clinical judgment in determining the timing of the COVID-19 vaccine. Investigators 
should document vaccinations. Investigators should notify patients of the risks of delaying the 
COVID-19 vaccination and document this along with any mitigation strategies for preventing 
COVID-19 infection. See Appendix 3 for the Pandemic Risk Assessment and Mitigation Plan.
5.9.1.3.
Prohibited Concomitant Medications
Anticancer therapies including chemotherapy, targeted therapies, and immunotherapy (apart 
from study drugs) are not permitted while patients are on study.
5.9.2.
Prior and Concomitant Medications With Nab-paclitaxel and Paclitaxel
The current local prescribing information should be followed for permitted and prohibited 
concomitant medications of nab-paclitaxel and paclitaxel.
5.9.3.
Prior and Concomitant Medications With Sacituzumab Govitecan
Palliative and/or supportive medications, such as pain medications, bone-modifying medications 
(bisphosphonates or denosumab), antiemetics or antidiarrheal medications, transfusions, and 
growth factor support are allowed at the investigator’s discretion. Palliative radiotherapy is 
permitted.
5.9.3.1.
Prior and Concomitant Medications That Are Prohibited or Used With Caution 
With Sacituzumab Govitecan
Patients are prohibited from receiving the following medications during the screening and 
treatment phase of this study:
•
Systemic anticancer therapies, aside from the study drugs. High-dose systemic 
corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of 
Cycle 1 Day 1. It should be noted that premedication with corticosteroids or the use of 
corticosteroids for treatment-related AEs are permitted. 
•
Live vaccines (examples include, but are not limited to, intranasal influenza vaccines, 
typhoid [oral] vaccines, and Bacillus Calmette-Guerin vaccine) within 30 days prior to 
randomization and while receiving study treatment.
Caution should be used when the following medications are used while the patient is receiving 
study treatment:

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•
UGT1A1 Inhibitors
SN-38 (the active metabolite of sacituzumab govitecan) is metabolized via human 
UGT1A1. Coadministration of sacituzumab govitecan with inhibitors of UGT1A1 may 
increase systemic exposure to the active metabolite, SN-38. UGT1A1 inhibitors should 
not be administered concomitantly with sacituzumab govitecan unless there are no 
therapeutic alternatives. A list of example UGT1A1 inhibitors is provided in 
Appendix 11.
•
UGT1A1 Inducers
SN-38 (the active metabolite of sacituzumab govitecan) is metabolized via human 
UGT1A1. Exposure to SN- 38 may be substantially reduced in patients concomitantly 
receiving UGT1A1 enzyme inducers. UGT1A1 inducers should not be administered 
concomitantly with sacituzumab govitecan unless there are no therapeutic alternatives. A 
list of example UGT1A1 inducers is provided in Appendix 11.
•
COVID-19 Vaccines
There is no substantial safety or efficacy data regarding the concurrent administration of 
the coronavirus disease 2019 (COVID-19) vaccine and sacituzumab govitecan. Patients 
are allowed to receive COVID-19 vaccines to reduce the risk and complications of 
COVID-19 infection, provided they are not live-attenuated vaccines. The study visits 
should continue as planned if vaccination occurs while the patient is on the study. See 
Appendix 3 for the Pandemic Risk Assessment and Mitigation Plan.
Should patients have a need to initiate treatment with any prohibited concomitant medication, the 
Gilead medical monitor must be consulted, and approval granted before initiation of the new 
medication. In instances where a prohibited medication is initiated before discussion with the 
Gilead medical monitor, the investigator must notify Gilead as soon as he/she is aware of the use 
of the prohibited medication.
5.10.
Dosage and Administration of Nab-paclitaxel and Paclitaxel
Nab-paclitaxel and paclitaxel should be administered according to local guidelines and practices. 
Study-specific considerations for nab-paclitaxel or paclitaxel dosing regimens for Safety Run-in 
Cohort 1 and Phase 2 Cohort 1 are described in Table 4 and Table 5, respectively.
For patients receiving magrolimab in combination with paclitaxel/nab-paclitaxel, Cycle 1 Day 1 
treatment can be administered over 2 days such that magrolimab is administered on Cycle 1 
Day 1 and paclitaxel/nab-paclitaxel on Cycle 1 Day 2. This also applies to repriming cycles that 
require Cycle 1 Day 1 dosing of magrolimab. Cycle 1 Day 1 dosing and infusion time 
requirements for each agent should be followed, as listed in Table 4 and Table 5. Premedication 
guidelines should be followed prior to magrolimab (see Section 5.8), paclitaxel/nab-paclitaxel 
(see Section 5.11). Patients should be observed during and following the infusion for signs or 
symptoms of IRRs (see Section 5.6 for magrolimab).

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5.11.
Nab-paclitaxel and Paclitaxel Premedication and Prophylaxis
Nab-paclitaxel and paclitaxel should be administered according to local guidelines and practices. 
Premedication for nab-paclitaxel is not required for prophylaxis. In contrast to paclitaxel 
(see below), steroid premedication is not required for use with nab-paclitaxel. However, patients 
with hypersensitivity reaction or IRR to nab-paclitaxel may be premedicated with corticosteroids 
for future dose administration at the discretion of the treating physician and can be discontinued 
for subsequent treatments if clinically indicated.
All patients should be premedicated prior to paclitaxel administration in order to prevent severe 
hypersensitivity reactions per their institutional standard of care or as follows. Such 
premedication may consist of oral dexamethasone 10 mg to 20 mg administered approximately 
12 and 6 hours before paclitaxel or dexamethasone less than or equal to 10 mg IV within 1 hour 
prior to paclitaxel infusion, diphenhydramine (or its equivalent) 50 mg IV 30 to 60 minutes prior 
to paclitaxel, and cimetidine (300 mg IV) or its equivalent IV 30 to 60 minutes before paclitaxel.
If paclitaxel is well tolerated during the first 2 weekly doses without an apparent hypersensitivity 
reaction, a taper in the dose of dexamethasone premedication (or equivalent) may be considered 
for subsequent cycles if permitted by institutional standard of care. This approach has been 
reported to be successful in the literature {Berger 2012}. 
5.12.
Dose Modifications for Nab-paclitaxel and Paclitaxel
Nab-paclitaxel and paclitaxel should be administered according to local guidelines and practices. 
Study-specific considerations for nab-paclitaxel or paclitaxel are provided as follows:
5.12.1.
Hematologic Toxicity
Nab-paclitaxel and paclitaxel are known to cause myelosuppression. The ANC must be at 
least 1500 cells/µL and platelet count must be at least 100,000 cells/µL on Day 1 of each cycle. 
Nab-paclitaxel and paclitaxel should not be administered on Days 8 or 15 of the cycle until 
counts recover to an ANC at least 500 cells/µL and platelets at least 50,000 cells/µL. 
If nab-paclitaxel or paclitaxel cannot be administered on Day 15 of the cycle, the next dose of 
nab-paclitaxel or paclitaxel should be administered on Day 1 of the following cycle when 
ANC and platelet counts have recovered to permissible levels. When dosing resumes, the 
nab-paclitaxel or paclitaxel doses should be permanently reduced as outline in Table 11.

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Table 11.
Nab-paclitaxel and Paclitaxel Reductions for Hematologic Toxicity
Hematologic Toxicity
Occurrence
Weekly Nab-paclitaxel 
Dose (mg/m2)
Weekly Paclitaxel Dose 
(mg/m2)
First
80
72
Second
60
54
Neutropenic fever (nadir ANC 
< 500 cells/µL with fever > 38 °C) or
Delay of next cycle by > 7 days for 
nadir ANC < 1500 cells/µL or
Nadir ANC < 500 cells/µL for > 7 days
Third
Discontinue treatment
Discontinue treatment
First
80
72
Nadir platelet count < 50,000 cells/µL
Second
Discontinue treatment
Discontinue treatment
ANC = absolute neutrophil count
5.12.2.
Neurological Toxicity
Table 12 presents the nab-paclitaxel and paclitaxel dose reductions for neurological toxicity. 
Nab-paclitaxel or paclitaxel should be withheld for Grade 3 or 4 peripheral neuropathy and may 
be resumed at reduced doses when peripheral neuropathy recovers to Grade 1 or full resolution.
Table 12.
Nab-paclitaxel and Paclitaxel Dose Reductions for Neurological 
Toxicity
Neurological 
Toxicity
Occurrence
Weekly Nab-paclitaxel Dose 
(mg/m2)
Weekly Paclitaxel Dose 
(mg/m2)
First
Withhold treatment until resolves to 
≤ Grade 1, then resume treatment at 
80 mg/m2
Withhold treatment until resolves 
to ≤ Grade 1, then resume 
treatment at 72 mg/m2
Second
Withhold treatment until resolves to 
≤ Grade 1, then resume treatment at 
60 mg/m2
Withhold treatment until resolves 
to ≤ Grade 1, then resume 
treatment at 54 mg/m2
Grade 3 or 4 
peripheral 
neuropathy
Third
Discontinue treatment
Discontinue treatment
5.12.3.
Hepatic Toxicity
Nab-paclitaxel should be withheld for Grade 3 or 4 hepatic toxicity as specified in Table 13. 
Given that magrolimab can cause a transient increase in indirect bilirubin due to on-target 
anemia, dose modifications for nab-paclitaxel in the case of bilirubin must not be attributed to 
magrolimab. In addition, the investigator should make all efforts to exclude malignant disease 
progression as a cause of liver enzyme derangement, which would not be considered a toxicity 
for nab-paclitaxel.

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Table 13.
Nab-paclitaxel and Paclitaxel Dose Reductions for Hepatic Toxicity
Hepatic Toxicity
Nab-paclitaxel 
Dose Modification
Paclitaxel 
Dose Modification
AST level < 10  ULN
or
Bilirubin level < ULN to 
1.25  ULN (not attributed to 
magrolimab and is mostly direct)
No dose modification; proceed with 
100 mg/m2
No dose modification; proceed with 
90 mg/m2
AST level < 10  ULN
and
Bilirubin level > 1.25 to 2  ULN 
(not attributed to magrolimab and is 
mostly direct)
Interrupt treatment until AST level 
< 10  ULN and bilirubin 
≤ 1.25  ULN, then reduce to 
80 mg/m2.
If toxicity does not resolve to above 
criteria within 3 weeks, discontinue 
treatment.
Interrupt treatment until AST level 
< 10  ULN and bilirubin 
≤ 1.25  ULN, then reduce to 
72 mg/m2.
If toxicity does not resolve to above 
criteria within 3 weeks, discontinue 
treatment.
AST level < 10  ULN
or
Bilirubin level > 2.00 to 5  ULN 
(not attributed to magrolimab and is 
mostly direct)
Interrupt treatment until AST level 
< 10  ULN and bilirubin 
≤ 1.25  ULN, then reduce to 
60 mg/m2.
If toxicity does not resolve to above 
criteria within 3 weeks, discontinue 
treatment.
Interrupt treatment until AST level 
< 10  ULN and bilirubin 
≤ 1.25  ULN, then reduce to 
54 mg/m2.
If toxicity does not resolve to above 
criteria within 3 weeks, discontinue 
treatment.
AST level > 10  ULN
or
Bilirubin level > 5  ULN (not 
attributed to magrolimab and is 
mostly direct)
Discontinue treatment
Discontinue treatment
AST = aspartate aminotransferase; ULN = upper limit of normal
5.12.4.
Pneumonitis
Interstitial pneumonitis has been observed in less than 1% of patients with nab-paclitaxel 
monotherapy and 4% with use of nab-paclitaxel in combination with gemcitabine. 
Monitor patients closely for signs and symptoms of pneumonitis.
Nab-paclitaxel should be permanently discontinued upon ruling out infectious etiology and 
making a diagnosis of pneumonitis related to nab-paclitaxel. Promptly initiate appropriate 
treatment and supportive measures. After ruling out infectious etiology, IV corticosteroid therapy 
should be instituted without delay, with appropriate premedication and secondary pathogen 
coverage. Treatment per institutional guidelines may be used.
5.12.5.
Other Toxicities
For any Grade 3 or 4 toxicity not mentioned above, related to nab-paclitaxel or paclitaxel, 
nab-paclitaxel or paclitaxel should be held until the patient recovers to Grade 1 or lower or 
baseline. Nab-paclitaxel or paclitaxel may be resumed at reduced doses when toxicity recovers to 
Grade 1 or lower or baseline. The treatment should then be resumed at 75% dose 
(permanent dose reduction) (Table 14). If recovery to Grade 1 or lower or baseline does not 

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occur within 3 weeks, then nab-paclitaxel or paclitaxel should be discontinued. No dose 
reductions should be made for Grade 1 or 2 toxicities.
Table 14.
Nab-paclitaxel and Paclitaxel Dose Reductions for Nonhematologic, 
Nongastrointestinal, Nonneurologic, and Nonhepatic Toxicity, 
Nonpneumonitis Toxicity
Adverse reaction
Occurrence
Weekly Nab-paclitaxel Dose 
(mg/m2)
Weekly Paclitaxel Dose 
(mg/m2)
First
80
72
Second
60
54
Grade 3 or 4 
nonhematologic, 
nongastrointestinal, 
nonneurologic, 
nonhepatic toxicity
Third
Discontinue treatment
Discontinue treatment
5.13.
Dosage and Administration of Sacituzumab Govitecan
5.13.1.
Sacituzumab Govitecan
Please use Pharmacy Manual as primary source of instructions for study drug preparation.
•
Administer sacituzumab govitecan at 10 mg/kg as an IV infusion on Days 1 and 8 of a 
21-day cycle. Sacituzumab govitecan should not be administered as an IV push or bolus.
•
The dose of sacituzumab govitecan will be calculated based on actual weight at 
enrollment/randomization (using weight obtained either at screening or on Cycle 1 Day 1) 
and should remain constant throughout the study, unless there is a greater than 10% change 
in body weight from baseline. Modifications to the study treatment doses administered 
should be made for a greater than 10% change in body weight from baseline and according to 
local and regional prescribing standards. Dose modifications for changes in body weight less 
than 10% may be made according to local institutional guidelines.
•
Administer the first infusion over 3 hours. Subsequent infusions may be administered over 
1 to 2 hours if previous infusions were well tolerated. Monitor the patient during, and for at 
least 30 minutes after infusion.
•
Protect the infusion bag from light.
•
An infusion pump may be used.
•
Compatibility with polypropylene, polyvinyl chloride, polypropylene and ethylene/propylene 
copolymer infusion bags has been demonstrated and are acceptable for use with sacituzumab 
govitecan.
•
Do not mix sacituzumab govitecan, or administer as an infusion, with other medicinal 
products.

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•
Upon completion of the infusion, flush the IV line with 20 mL 0.9% sodium chloride 
injection.
•
Sacituzumab govitecan is a cytotoxic drug and applicable special handling and disposal 
procedures should be followed.
For patients receiving magrolimab in combination with sacituzumab govitecan (Safety Run-in 
Cohort 2 and Cohort 2), Cycle 1 Day 1 treatment can be administered over 2 days such that 
magrolimab is administered on Cycle 1 Day 1 and sacituzumab govitecan on Cycle 1 Day 2. 
This also applies to repriming cycles that require Cycle 1 Day 1 dosing of magrolimab. Cycle 1 
Day 1 dosing and infusion time requirements for each agent should be followed, as listed in 
Table 6 and Table 7. Premedication guidelines should be followed prior to magrolimab 
(see  Section 5.8) and sacituzumab govitecan (see Section 5.14). Patients should be observed 
during and following the infusion for signs or symptoms of IRRs (see Section 5.6 for 
magrolimab and Section 5.13 for sacituzumab govitecan). 
5.14.
Sacituzumab Govitecan Premedication and Prophylaxis
Guidance for premedication for prevention of toxicities associated with sacituzumab govitecan is 
presented in Table 15.
Table 15.
Guidance for Premedication and Prophylaxis for Toxicities 
Associated With Sacituzumab Govitecan
Potential Reaction
Premedication and Prophylaxis Guidance
Infusion-related reaction
•
Antipyretics and H1/H2 blockers should be administered before each 
sacituzumab govitecan infusion.
•
Corticosteroids (hydrocortisone 50 mg or equivalent PO or IV) may be 
administered prior to infusions.
Nausea and vomiting
•
Premedication with a 2-drug antiemetic regimen is recommended.
•
If nausea and vomiting are persistent, a 3-drug regimen may be used, including 
a 5-HT3 inhibitor (ondansetron or palonosetron, or other agents according to 
local practices), an NK1-receptor antagonist (fosaprepitant or aprepitant), and 
dexamethasone (10 mg PO or IV).
•
Anticipatory nausea can be treated with olanzapine.
Neutropenia
•
Complete blood counts must be obtained prior to each sacituzumab govitecan 
infusion and treatment should be administered if ANC meets the following 
criteria:

Day 1: ANC ≥ 1500/mm3

Day 8: ANC ≥ 1000/mm3
•
Use of G-CSF: Primary prophylaxis is highly recommended for patients at risk 
of febrile neutropenia based on current ASCO/ESMO guidelines for use of 
growth factors. Secondary prophylaxis for ≥ 3 Grade neutropenia is 
recommended.
ANC = absolute neutrophil count; ASCO = American Society of Clinical Oncology; ESMO = European Society for 
Medical Oncology, G-CSF = granulocyte-colony stimulating factor; IV = intravenous; PO = orally

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5.15.
Dose Modifications for Sacituzumab Govitecan
The major toxicities of sacituzumab govitecan are expected to be gastrointestinal symptoms and 
neutropenia. Premedication and prophylaxis for the prevention of sacituzumab 
govitecan-associated toxicities are described in Section 5.14. Management of toxicities should be 
in accordance with best clinical practices, standard institutional guidelines, and current 
ASCO/ESMO guidelines. All patients will be closely monitored over the course of their 
treatment and aggressively medically managed, including dose reduction and interruption, to 
prevent the need for treatment discontinuation and serious complications of these toxicities.
All efforts to avoid dose reduction should be taken to address toxicity prior to initiation of dose 
reduction. Use of primary and secondary prophylaxis with granulocyte-colony stimulating factor 
(G-CSF) is highly recommended for patients at risk for high grade neutropenia and febrile 
neutropenia. Instructions for dose modification and discontinuation of sacituzumab govitecan for 
treatment-related toxicities are provided in Section 5.15.2 and instructions for treatment delays 
are provided in Section 5.15.1. Instructions for management of toxicities known to occur with 
sacituzumab govitecan is provided in Section 7.8.3.
Treatment delays for other study drugs are described in Section 5.6.1 (magrolimab) and 
Section 5.12 (nab-paclitaxel and paclitaxel). Dose modification and discontinuations are 
described in Section 5.7 (magrolimab) and Section 5.12 (nab-paclitaxel and paclitaxel).
5.15.1.
Treatment Delays for Sacituzumab Govitecan
Sacituzumab govitecan will be administered in 21-day cycles on Days 1 and 8; the next cycle 
should start 14 days after the Day 8 dose (ie, the Day 8 infusion will be counted as the first day 
of that 14-day period). However, visit windows of ± 3 days of the scheduled infusion are 
permitted. At a minimum, 6 days are required between sacituzumab govitecan doses. The 
scheduled Day 1 and Day 8 infusions may be delayed for up to 3 weeks for treatment-related 
toxicities.
Instructions for dose delays and dose reductions for specific toxicities are summarized below. 
See Table 15 for when sacituzumab govitecan can be administered based on ANC. Withhold 
sacituzumab govitecan administration for Grade 3 nausea or Grade 3 or 4 diarrhea or vomiting at 
the time of the scheduled treatment administration and resume sacituzumab govitecan when 
resolved to at least Grade 1. For toxicities not specifically addressed in Table 16, dosing may be 
delayed for greater than Grade 2 toxicities related to sacituzumab govitecan treatment for a 
maximum of 3 weeks. If the toxicity has improved to at least Grade 2, the dose should be 
administered at that time. For a toxicity that delays Day 8 dosing, if treatment is delayed for 
more than 1 week, dosing should resume as Day 1 of the next cycle. Regardless of whether the 
Day 8 dose is delayed for toxicity, there should be 14 days between the Day 8 infusion and the 
Day 1 infusion of the next cycle.

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Palliative radiotherapy is permitted. If there is clear evidence of clinical benefit, treatment may 
be continued after completion of palliative radiotherapy. In this case, sacituzumab govitecan 
administration should be interrupted 1 week before the procedure and reinstated no earlier than 
2 weeks after the procedure. In the event a patient requires surgery, sacituzumab govitecan 
should be interrupted 1 week before the procedure if clinically feasible and dosing should be 
held for 2 weeks after the procedure. Dosing may resume thereafter if the patient is clinically 
stable. Extensive surgical procedures (eg, abdominal, cranial surgeries) may require suspension 
of dosing for 4 weeks to allow for an adequate period for healing before dosing may resume. The 
study medical monitor must approve continuation of therapy with sacituzumab govitecan before 
resumption of dosing (see Section 3.4 for discontinuation criteria).
Treatment interruptions for reasons other than resolution of toxicities/procedures are not 
permitted outside of the permitted visit windows.
5.15.2.
Dose Reductions and Discontinuation for Sacituzumab Govitecan
Table 16 summarizes recommendations for sacituzumab govitecan dose reductions and 
discontinuations for treatment-related toxicities.
Sacituzumab govitecan dose reductions and interruptions will be managed based on toxicity 
severity. Leukopenia or lymphopenia in the absence of neutropenia does not require dose 
modification. The sacituzumab govitecan dose must not be re-escalated following a dose 
reduction. 
The sacituzumab govitecan treatment must be discontinued if there is more than a 5-week dose 
delay from the planned treatment date, regardless of reason, or more than a 3-week dose delay 
from the planned treatment date due to sacituzumab govitecan-related toxicity.

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Table 16.
Recommended Dose Modification Schedule for Sacituzumab Govitecan
Adverse Reaction
Occurrence
Dose Modification or Action
Severe neutropenia 
First
25% dose reduction from initial dose and 
administer G-CSF as soon as clinically 
indicated.
Initiate secondary prophylaxis with G-CSF.
Second
50% dose reduction from initial dose and 
administer G-CSF as soon as clinically 
indicated.
Initiate secondary prophylaxis with G-CSF, 
if not done earlier.
Grade 4 neutropenia ≥ 7 days,
OR
Grade 3-4 febrile neutropenia,
OR
At time of scheduled treatment, Grade 3 or 4 neutropenia that delays dosing by 2 or 
3 weeks for recovery to ≤ Grade 1
Third
Discontinue Treatment
At time of scheduled treatment, Grade 3 or 4 neutropenia that delays dosing beyond 
3 weeks for recovery to ≤ Grade 1
First
Discontinue treatment
Severe nonneutropenic toxicity
First
25% dose reduction
Second
50% dose reduction
Grade 4 nonhematologic toxicity of any duration,
OR
Any Grade 3 or 4 nausea, vomiting, or diarrhea due to treatment that is not controlled 
with antiemetics and antidiarrheal agents,
OR
Other Grade 3 or 4 nonhematologic toxicity persisting > 48 hours despite optimal 
medical management,
OR
At time of scheduled treatment, Grade 3 or 4 nonneutropenic hematologic or 
nonhematologic toxicity that delays dose by 2 or 3 weeks for recovery to ≤ Grade 1
Third
Discontinue treatment
In the event of Grade 3 or 4 nonneutropenic hematologic or nonhematologic toxicity that 
does not recover to ≤ Grade 1 within 3 weeks 
First
Discontinue treatment
Infusion-Related Toxicities
Grade 2 or Grade 3 infusion-related reaction despite optimal management
Recurrent
Discontinue treatment
Grade 4 infusion-related reaction
First
Discontinue treatment
G-CSF = granulocyte-colony stimulating factor

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5.16.
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, 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
5.16.1.
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, Appendix Table 2, and Appendix Table 3, and described in the 
following sections.
The investigator must document any deviation from the protocol procedures and notify Gilead or 
the contract research organization (CRO).
6.1.
Patient Enrollment and Treatment Assignment
Entry into screening does not guarantee enrollment onto 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.
Treatment assignment for patients in Phase 2 Cohort 1 will be randomized using IRT. Patients 
will be assigned to receive magrolimab in combination with choice of either nab-paclitaxel or 
paclitaxel or either nab-paclitaxel or paclitaxel in a 1:1 ratio. Nab-paclitaxel or paclitaxel use will 
be per investigator discretion and in accordance with local guidelines and practices.
Patients in Phase 2 Cohort 2 will be assigned to receive magrolimab in combination with 
sacituzumab govitecan.
6.2.
Pretreatment Assessments
6.2.1.
Prescreening
Prior to providing consent for the study, an optional prescreening consent form may be offered to 
patients at the investigator's discretion to permit the collection and analysis of blood samples for 
extended RBC phenotyping or genotyping, type and screen (ABO/Rh [any of the 4 blood groups 
A, B, AB, and O comprising the ABO system/Rhesus factor]), and direct antiglobulin test 
(DAT).
6.2.2.
Screening Visit
Patients will be screened within 30 days before dosing on Cycle 1 Day 1 to determine eligibility 
for participation in the study. Assessments performed as part of standard of care prior to ICF 
signature may be used if they are within the required screening period. For patients enrolled in 
Cohort 1 Arm B with documented progressive disease that rescreen to enroll in Cohort 2, 
assessments performed under Cohort 1 patient ID can be used if within the required screening 
period. The following will be performed and documented at screening per Appendix 2:
•
Obtain written informed consent
•
Obtain medical history including concomitant medications
•
Obtain demographic information

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•
Complete physical examination, including vital signs, body weight, and height
•
Confirm diagnosis of TNBC by histology or cytology performed at a local laboratory
•
Obtain PD-L1 test result (if prior diagnostic PD-L1 report is not available)
•
Obtain blood and urine samples for the following tests: chemistry, hematology, coagulation, 
urinalysis, serum pregnancy, blood phenotyping or genotyping, type and screen, and DAT 
(Section 6.4.2). Blood for biomarker samples will also be collected 
•
Tumor biopsy (Section 6.9)
•
ECOG
•
Perform 12-lead ECG (single)
•
Record all serious AEs (SAEs) related to protocol-required procedures occurring after 
signing of the ICF
From the time of obtaining informed consent through the first administration of study drug, 
record all SAEs that are considered 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. For patients 
enrolled in Cohort 1 Arm B with documented progressive disease that rescreen to enroll in 
Cohort 2, AEs should be reported under their Cohort 1 patient ID until they receive the first 
treatment dose in Cohort 2, and ongoing AEs from Cohort 1 should be captured as 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 for Phase 2 Cohort 1 
must be conducted within 3 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 at least 54 years of age with cessation of 
previously occurring menses for at least 12 months without an alternative cause. In addition, 
women of less than 54 years of age with amenorrhea of at least 12 months may also be 
considered postmenopausal if their follicle-stimulating hormone level is in the postmenopausal 

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range and they are not using hormonal contraception or hormonal replacement therapy. A 
negative serum pregnancy test is required at screening, and a negative pregnancy test is required 
prior to study treatment administration on Cycle 1 Day 1. The Cycle 1 Day 1 pregnancy test does 
not need to be repeated if the screening pregnancy test was performed within the 72 hours before 
study treatment administration. Pregnancy tests will also be required at Day 1 of each subsequent 
cycle and continue monthly up to 6 months after the end of treatment (EOT) per the duration of 
required contraception as discussed in Appendix 5. For further details, refer to Appendix 5.
6.4.2.
Type and Screen and Direct Antiglobulin Test
Due to the risk of developing anemia, blood type and screen (ABO/Rh), DAT, and extended 
RBC phenotyping (including minor antigens such as Rh, CcDEe, Cw, MNSs, Kk, Fya, Fyb, Jka, 
and Jkb) will be performed at screening before exposure to magrolimab, as described in 
Section 7.8.1.1. An extended genotype (instead of an RBC phenotype) will be performed if a 
patient received any RBC or whole blood transfusion within the previous 3 months. 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 are to 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 
infusion/injection of magrolimab, nab-paclitaxel, paclitaxel, or sacituzumab govitecan at the 
visits specified in the schedules of assessments in Appendix Table 1, Appendix Table 2, and 
Appendix Table 3.
6.4.4.
Physical Examination
Complete physical examination is to 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 8).
6.4.6.
Electrocardiograms
A single ECG will be performed at screening. Additional ECG requirements for sites in the UK 
are provided in Appendix 12. 

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6.4.7.
Patient-reported Outcomes
Three PRO instruments will be administered in Phase 2 Cohort 1 of this study: the European 
Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 
Questionnaire (EORTC-QLQ-C30) and accompanying breast cancer module 
(EORTC-QLQ-BR23) and the EQ-5D-5L. The patient should complete these questionnaires 
before any other study procedures conducted the same day at required visits. Please refer to 
schedules of assessments in Appendix Table 1 and Appendix Table 3 for timing of 
PRO assessments. If the PRO 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 EORTC-QLQ-BR23
The EORTC-QLQ-C30 is a reliable and valid measure of PRO and has been widely used among 
cancer patients. 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 breast 
cancer, EORTC-QLQ-BR23, has an additional 23 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 EuroQol 
(5 dimensions) (EQ-5D) descriptive system and the EQ visual analogue scale (EQ-VAS). A 
sample is provided in Appendix 7.
The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight 
problems, moderate problems, severe problems, and extreme problems. The patient is asked to 
indicate his/her health state by ticking the box next to the most appropriate statement in each of 
the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for 
that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that 
describes the patient’s health state.
The EQ-VAS records the patient’s self-rated health on a vertical VAS, where the 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 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.

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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. Concomitant 
medication associated with procedure-related AEs will be captured from the time of informed 
consent and onward. Information to be collected includes therapy 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 schedules of 
assessments (Appendix Table 3).
6.5.
Safety Assessments
Table 17 presents analytes to be assessed by the local and/or central laboratory or specialty 
laboratories at screening. Refer to Section 7.8.1.2 for hemoglobin testing requirements for the 
first 2 magrolimab doses predose and postdose monitoring.
Table 17.
Screening Laboratory Analytes
Chemistry
(Serum or Plasma)
Hematology
Urinalysisa
Other Laboratory 
Measurements
Sodium
Potassium
Chloride
Bicarbonateb
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
Absolute neutrophil 
count
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 
genotypingc 
Type and screen (ABO/Rh), 
DAT
ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; ALT = alanine aminotransferase; 
aPTT = activated partial thromboplastin time; AST = aspartate aminotransferase; BUN = blood urea nitrogen; DAT = direct 
antiglobulin test; INR = international normalized ratio; PT = prothrombin time; PTT = partial thromboplastin time; RBC = red 
blood cell; Rh = Rhesus factor; SGOT = serum glutamic oxaloacetic transaminase; SGPT = serum glutamic pyruvic 
transaminase; WBC = white blood cell
a
Reflex microscopic testing based on other abnormalities.
b
If available at local laboratory.
c
Test may be performed at a central laboratory or local laboratory, if available. 
Analytes are required to be collected at or before screening. Refer to Appendix Table 1 and Appendix Table 2 for collection time 
points.

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Table 18 presents analytes to be assessed by the local and/or central laboratory or specialty 
laboratories during the study.
Table 18.
Study Laboratory Analytes 
Chemistry 
(Serum or Plasma)
Hematology
Other Laboratory Measurements
Sodium
Potassium
Chloride
Bicarbonatea
Total protein
Albumin
Calcium
Magnesium
Phosphorus (serum)
Glucose
BUN or urea
Creatinine
Uric acid (serum)
Total bilirubin
Direct bilirubin
Indirect bilirubin
AST (SGOT)
ALT (SGPT)
Alkaline phosphatase
Haptoglobin
LDH
RBC
Hemoglobin
Hematocrit
Platelets
WBC
Absolute neutrophil count
Eosinophils
Basophils
Lymphocytes
Monocytes
Reticulocytes
Pregnancy (urine or serum)
Blood and tumor samples for 
biomarker analysis
Pharmacokineticsb
Antidrug antibodiesb
ALT = alanine aminotransferase; AST = aspartate aminotransferase; BUN = blood urea nitrogen; LDH = lactate dehydrogenase; 
RBC = red blood cell; SGOT = serum glutamic oxaloacetic transaminase; SGPT = serum glutamic pyruvic transaminase; 
WBC = white blood cell
a
If available at local laboratory.
b
These assays will be performed at a central laboratory.
Analytes are required to be collected at visits during study. Refer to Appendix Table 1, Appendix Table 2, and Appendix Table 3 
and for collection time points.
6.6.
Efficacy Assessments
For the Safety Run-in Cohort 1 and Phase 2 Cohort 1, computed tomography (CT) or magnetic 
resonance imaging (MRI) scans with IV contrast of the chest, abdomen, pelvis, and other 
involved disease sites are to be performed at the screening visit, every 8 weeks (± 7 days) during 
the study (starting from Cycle 1 Day 1), and at the EOT visit if one has not been performed 
within the last 30 days or progressive disease has been documented.
For Safety Run-in Cohort 2 and Phase 2 Cohort 2, CT or MRI scans with IV contrast of the 
chest, abdomen, pelvis, and other involved disease sites are to be performed at the screening 
visit, every 6 weeks (± 7 days) through 36 weeks (Weeks 6, 12, 18, 24, 30, and 36) during the 
study, then every 9 weeks (± 7 days) (starting at Cycle 1 Day 1), and at the EOT visit if one has 
not been performed within the last 30 days or progressive disease has been documented. 

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A brain MRI with contrast is required for all patients during screening. Patients with a history of 
or presence of brain metastases at baseline will also be required to have a contrast MRI of the 
brain performed at the same frequency and schedule as the non-CNS imaging while on 
treatment. Brain CT will be acceptable if MRI is medically contraindicated.
Tumor burden will be evaluated solely based on radiographic imaging per RECIST, Version 1.1. 
Chest x-ray, ultrasound, endoscopy, laparoscopy, positron emission tomography (PET), 
radionuclide scans, or tumor markers will not be considered for response assessment. PET/CT 
may be utilized per the investigator’s discretion if a high-quality CT scan is included.
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 reported lesion at baseline and during study treatment and 
follow-up. All sites of measurable and nonmeasurable disease must be documented at screening 
and reassessed at each subsequent tumor evaluation.
Scans taken as part of standard medical practice up to 30 days prior to enrollment can be used for 
screening as long as they meet all study requirements. Tumor assessments are to be performed at 
the time points specified in Appendix Table 1 and Appendix Table 2, regardless of dosing delays 
or interruptions. Additional scans may be performed at the discretion of the treating physician to 
assess disease status as clinically indicated.
For patients who stop study treatment in the absence of disease progression per RECIST, 
Version 1.1 (eg, experience unexpected toxicity), scans should continue to be collected 
approximately every 8 weeks (± 7 days) for Safety Run-in Cohort 1 and Phase 2 Cohort 1 
patients and every 9 weeks (± 7 days) for Safety Run-in Cohort 2 and Phase 2 Cohort 2 patients 
until disease progression or initiation of systemic antitumor therapy other than the study 
treatment, whichever is earlier.
All relevant clinical and radiographic information required to make each assessment must be 
made available for source verification. Disease progression will be determined by the 
investigator or qualified designee.
Patients will be assessed for response using RECIST, Version 1.1 for the primary efficacy 
endpoint and for the secondary efficacy endpoint (Appendix 10). Palliative radiation of the target 
lesion will render that target lesion and subsequent tumor assessments “not evaluable” and 
should be avoided. Consult with the sponsor prior to palliative radiation if possible. If palliative 
radiotherapy is given (Section 5.9), presence of new or worsening metastases will be considered 
progression. If the radiologic assessment does not confirm disease progression, patients should 
continue to be assessed per the study procedures (Appendix Table 1 and Appendix Table 2).
6.7.
Pharmacokinetic Assessments
Magrolimab serum concentration will be measured by a validated enzyme-linked immunosorbent 
assay (ELISA) immunoassay method.

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Blood samples for PK assessment will be collected predose at multiple time points from patients 
who received magrolimab according to the schedule of assessments in Appendix Table 4. (Note 
the additional sample collected ostdose on C cle 3 Da 1 at 1 h ± 15 min after the end of 
ma ·olimab infusion. 
6.8. 
Immunogenicity (Antidrug Antibodies) 
Peripheral blood for immunogenicity assessments for ADA against magrolimab will be collected 
as described in the schedules of assessments for all patients (Appendix Table 4). When collected 
on the day of study drng dosing, the ADA blood sample must be collected at the same time as the 
predose PK sample. The presence of anti-magrolimab antibodies will be detennined by a 
validated electrochemiluminescence immunoassay method. 
6.9. 
Biomarker Assessments 
Biomarker samples will be collected to assess the PD, MOA, and treatment response biomarkers, 
and to define conelates of clinical efficacy and/or safety, as outlined in Section 3.8. The 
biomarker sample collection schedules are outlined in Appendix Table 4. 
Patients are required to submit a mandato1y pretreatment core needle or excisional tumor biopsy 
(fine needle aspirate is not adequate) from a site not previously i1Ta.diated, unless not feasible as 
detennined by the investigator and discussed with the sponsor. A newly obtained biopsy, 
collected within 90 days prior to study treatment staii, is strongly prefen ed, but an ai·chival 
sample is acceptable. For ai·chival samples submitted in lieu of newly obtained biopsies, tissue 
collected within 6 months prior to study treatment strut is strongly prefened whenever possible. 
Archival samples ai·e requested to be submitted as tissue blocks or, if a block is not available, at 
least 20 to 25 newly sectioned unstained slides. 
Patients will also submit a mandato1y on-treatment core needle or excisional tumor biopsy unless 
not feasible as detennined by the investigator and discussed with the sponsor. 
For patients emolled in Cohort 1 Ann B with documented progressive disease that rescreen to 
emoll in Coho1i 2, a tumor biopsy should be perfo1med at the time of rescreening, whenever 
possible. Alternatively, tissue from on-treatment biopsy submitted as paii of Coho1t 1 
assessments ai·e acceptable, if available. If collection of recent or new tissue is not feasible, the 
patient may be exempt from the screening tissue requirement with sponsor approval. 
For additional details and instrnctions regai·ding tissue requirements and procedures for sample 
collection, storage, and shipment, refer to the Study Laborato1y Manual. 
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6.10.
Posttreatment Assessments
Posttreatment assessments are provided in Appendix Table 3. There are 2 types of follow-up 
visit: safety follow-up (30 days [± 7 days] after the last dose of study drug) and survival 
follow-up (every 2 months [± 7 days] after safety follow-up). Patients who discontinue study 
treatment are to return for an EOT 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 telephone 
call 30 days (± 7 days) after their last dose of study treatment. When an SAE or treatment-related 
AE is reported during the 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 EOT per 
the duration of required contraception as discussed in Appendix 5. Testing during 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 every 2 months until death or end of study. Duration of 
survival follow-up will be limited to 3 years.
6.11.
Assessments for Early Discontinuation From Study
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, Criteria for Discontinuation of Study Treatment). In 
the absence of disease progression, scans should continue to be collected per Section 6.6 
Efficacy Assessment, until disease progression or initiation of systemic antitumor therapy other 
than the study treatment, whichever is earlier. If this is not possible or acceptable to the patient or 
investigator, the patient may be withdrawn from the study. 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 3), 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.
6.11.1.
Criteria for Discontinuation of Study Treatment
Criteria for discontinuation of study treatment is provided in Section 3.4.
6.12.
Criteria for Discontinuation From Study/End of Study
Criteria for discontinuation from study is provided in Section 3.5.
6.13.
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, survival, and 
AEs as specified in Appendix Table 1 and Appendix Table 2. Poststudy treatment assessments 
are described in Appendix Table 3.

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Sample Storage 
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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.)
•
In-patient hospitalization or prolongation of existing hospitalization.

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

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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.
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.

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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).
7.2.2.
Assessment of Severity
The severity of AEs will be graded using 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 medication, all AEs, regardless of cause or relationship, will be 
collected until 30 days after last administration of study drug 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 Patient Safety (PS) as instructed below 

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in this section. This also includes any SAEs resulting from protocol-associated procedures 
performed after the ICF is signed.
Any SAEs and deaths that occur after the posttreatment follow-up visit but within 30 days of the 
last dose of study drug, regardless of causality, should also be reported.
Investigators are not obligated to actively seek SAEs after the protocol-defined follow-up period; 
however, if the investigator learns of any SAEs that occur after the protocol-defined follow-up 
period has concluded and the event is deemed relevant to the use of study drug, the investigator 
should promptly document and report the event to Gilead PS.
Instructions for reporting SAEs are described in Section 7.4.1.
7.3.4.
Study Drug Special Situations Reports
All study drug SSRs that occur from study drug initiation and throughout the duration of the 
study, including the posttreatment follow-up visit, must be reported to Gilead PS (Section 7.4.2). 
Adverse events and SAEs resulting from SSRs must be reported in accordance to the AE and 
SAE reporting guidance (Section 7.4).
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.

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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.
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 PS
Email: Safety_FC@gilead.com 
or
Fax: 1-650-522-5477
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.

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Gilead PS
Email: Safety_FC@gilead.com 
or
Fax: 1-650-522-5477
See Section 7.4.2.2 for instructions on reporting special situations with Gilead concomitant 
medications.
7.4.2.2.
Reporting Process for Gilead Concomitant Medications
Special situations that involve concomitant medications manufactured by Gilead that are not 
considered study drugs must be reported within 24 hours of the investigator’s knowledge of the 
event to Gilead PS utilizing the paper SSR form to:
Gilead PS
Email: Safety_FC@gilead.com 
or
Fax: 1-650-522-5477
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 patients who 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 using the pregnancy report form within 24 hours of becoming aware of the 
pregnancy. 
In the sacituzumab govitecan cohort only (Safety Run-in Cohort 2 and Phase 2 Cohort 2), the 
investigator should report pregnancies in female partners of male patients that are identified after 
initiation of study drug and throughout the study, including the protocol-required posttreatment 
follow-up period or 3 months after the last dose of sacituzumab govitecan, whichever is longer, 
to Gilead PS within 24 hours of becoming aware of the pregnancy using the pregnancy report 
form.

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Contact details for transmitting the pregnancy report form are as follows:
Gilead PS
Email: Safety_FC@gilead.com 
or
Fax: 1-650-522-5477
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 poststudy 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: Safety_FC@gilead.com and fax: +1 (650) 522-5477.
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 Code of 
Federal Regulations, 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.
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.

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7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not to be recorded as AEs or SAEs. 
However, laboratory abnormalities (eg, clinical chemistry, hematology, urinalysis) that require 
medical or surgical intervention or lead to study drug interruption, modification, or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, ECG, x-rays, vital signs) that are associated with 
signs and/or symptoms must be recorded as an AE or SAE if they meet the definition of an AE 
or SAE as described in Sections 7.1.1 and 7.1.2. If the laboratory abnormality is part of a 
syndrome, record the syndrome or diagnosis (eg, anemia), not the laboratory result (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, 
pre-existing 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 {U.S. Department of 
Health and Human Services 2009}, as:
•
Treatment-emergent ALT or AST elevation (at least 3  ULN), AND
•
Treatment-emergent total bilirubin elevation (more than 2  ULN), and absence of 
cholestasis (defined as alkaline phosphatase less than 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).
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 

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phenotyping difficult, ABO/Rh type, antibody screen, blood phenotyping or genotyping, and 
DAT need to be performed at screening before exposure to magrolimab, as described in 
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 RBC 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 Hb of about 0.5 to 1.5 g/dL observed in the first 1 to 2 weeks of treatment. This 
decrease in Hb level had been acceptable in patients with no other significant diseases or medical 
conditions. However, 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. Significant drops (up to 2 g/dL or higher) have also 
been observed in early doses.
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. Patients in South Korea are not permitted to be transfused to 
meet eligibility criteria (Inclusion Criterion #5a, Exclusion Criterion #4).
Patients with a low baseline Hb 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. This, coupled with anemia from 
other causes in patients with cancers, means that care must be taken with RBC cross-matching 
and packed RBC transfusions.
Prior to initiation of magrolimab, ABO/Rh type and screen, DAT, and extended RBC 
phenotyping (including minor antigens Rh, CcDEe, Cw, MNSs, Kk, Fya, Fyb, Jka, and Jkb) will 
be performed for each patient. Extended RBC genotyping instead of extended RBC phenotyping 
is acceptable for any patient. An extended genotype (instead of an RBC phenotype) must be 
performed if a patient received any RBC or whole blood transfusion within the previous 
3 months (unless laboratory has availability for special techniques for performing phenotyping 
for patients with recent transfusion). Results must be available before the first dose of 
magrolimab. 

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For Patients After Exposure to Magrolimab:
An additional hemoglobin must be checked 3 to 6 hours after the initiation of the first and second 
doses of magrolimab during initial treatment. The patient should be transfused as clinically 
appropriate. Investigators should consider additional hemoglobin monitoring during the first 
week of treatment in patients with symptoms of anemia or at increased risk for complications of 
anemia.
Blood Components for Transfusion:
For all elective RBC and platelet transfusions, use leukocyte-reduced and gamma-irradiated units 
per institutional guidelines. For RBC transfusions, phenotype/genotype-matched units are 
preferred. Cytomegalovirus (CMV)-seronegative units for CMV-seronegative patients will not 
be 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 by use of gamma-clone anti-IgG and multiple alloadsorption 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 from the start of the infusion. Premedication use described in Section 5.8 will 
be used to manage IRRs preemptively.
Recommendations for the management of IRRs are provided below:
•
For Grade 1 IRRs, described as mild transient reaction, infusion interruption is not indicated 
and intervention not indicated:
Remain at bedside and monitor patient until recovery from symptoms.

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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.
•
For Grade 2 IRR, described as requiring symptomatic treatment and prophylactic 
medications (eg, antihistamines, nonsteroidal anti-inflammatory drugs, narcotics, 
corticosteroids, IV fluids) for ≤ 24 hours, infusion interruption is indicated:
Stop the magrolimab infusion, 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 will be administered at that visit.
Patients who experience IRR 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 or lower 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.
•
For Grade 3 IRR, described as prolonged reactions or recurrence of symptoms following 
initial improvement, or where hospitalization is indicated for other clinical sequelae 
(eg, renal impairment, pulmonary infiltrates), or Grade 4 IRR, described as having 
life-threatening consequences, where urgent intervention is indicated:
Immediately discontinue infusion of magrolimab.
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 
subcutaneous 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.

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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 should be permanently discontinued 
from the study treatment.
For anaphylaxis, investigators should follow their institutional guidelines for treatment.
All patients with Grade 3 or greater 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.
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 or CT, and pulmonary consultation. 
Management of potential pneumonitis is detailed in Table 19 and follows ASCO guidelines for 
immune-related AEs {Brahmer 2018}. Patients who experience Grade 3 to 4 pneumonitis will be 
permanently discontinued from study treatment.

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Table 19.
Management of Pneumonitis
Pneumonitis Management Algorithm
CTCAE Grade of Pneumonitis
Management
Follow-up
Grade 1
Radiographic changes 
(CXR or CT) only.
Monitor for signs and 
symptoms weekly and consider 
monitoring with CXR.
Consider pulmonary and 
infectious disease consults.
Consider reimaging with CT in 3-4 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 2-3 days; consider 
hospitalization.
1 mg/kg/day oral prednisone or 
IV equivalent.
Consider bronchoscopy, lung 
biopsy.
Re-image every 1-3 days.
If improving to baseline, taper 
corticosteroids over 4-6 weeks and 
resume magrolimab therapy per protocol.
If no clinical improvement after 
48-72 hours or worsening, treat as 
Grade 3-4.
Grade 3-4
Severe new symptoms; 
new/worsening hypoxia; life-
threatening.
Discontinue magrolimab 
therapy.
Hospitalize.
Pulmonary and infectious 
disease consults.
1-2 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 4-6 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; CXR = chest x-ray; 
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.

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7.8.1.6.
Severe Neutropenia
Prophylaxis
Severe neutropenia and febrile neutropenia were reported in patients treated with magrolimab in 
combination with chemotherapy. Close monitoring of hematologic parameters (Appendix 
Table 1 and Appendix Table 2) including neutrophils is required for all patients treated with 
magrolimab. For patients with high risk of developing Grade 4 neutropenia and febrile 
neutropenia, primary and secondary prophylaxis with G-CSF is highly recommended. 
Prophylactic use of antimicrobials may be considered at the discretion of the treating physician. 
Management of Neutropenia
•
For Grade 3 neutropenia (ANC 500 - 1000/μL) without fever or infection, delay of 
magrolimab dosing is not recommended.
•
For Grade 4 neutropenia (ANC < 500/μL) without fever or infection, or ≥ Grade 3 
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 Grade 4 neutropenia (≥ 7 days) or febrile neutropenia (> 2 occurrences) 
not attributed to other causes, discontinuation of magrolimab may be considered.
•
Treatment with G-CSF should be initiated as soon as clinically indicated.
7.8.1.7.
Management of 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 patients being treated for serious infections, hold the next dose of magrolimab until the 
infection has resolved clinically. 
•
For serious infections that remain active for ≥ 14 days, consider discontinuation of 
magrolimab.
7.8.2.
Nab-paclitaxel and Paclitaxel
Refer to nab-paclitaxel and paclitaxel local prescribing information and local guidelines for 
safety management. Additional considerations for safety management for nab-paclitaxel and 
paclitaxel are described in Section 5.3.3.

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7.8.3.
Sacituzumab Govitecan
For dose reductions and discontinuations for other treatment-related toxicities, please refer to 
Section 5.15.2. Refer to sacituzumab govitecan local prescribing information and local 
guidelines for safety management. Additional considerations for safety management are 
provided below. 
7.8.3.1.
Gastrointestinal Toxicities
Nausea, vomiting, and diarrhea are frequent sacituzumab govitecan-associated toxicities. 
Appropriate treatment, including, as needed, fluid and electrolyte replacement, is required to 
minimize the risk of serious consequences such as dehydration. Instructions for sacituzumab 
govitecan dose reduction for treatment-related gastrointestinal toxicities are provided in 
Table 16.
Nausea and Vomiting
Instructions for the use of premedications for prophylactic treatment of nausea and vomiting and 
anticipatory nausea are provided in Table 15. Do not hold the dose of sacituzumab govitecan for 
Grade 3 nausea unless Grade 3 nausea persists despite maximal optimal medical management. 
Patients should be treated for delayed nausea and vomiting on Days 2 and 3 with 5-HT3 receptor 
antagonist (ondansetron or palonosetron) monotherapy and other agents if needed. Steroids may 
be added if symptoms do not resolve with these agents. Consider olanzapine for persistent or 
anticipatory nausea; an olanzapine dose of 2.5 mg or 5 mg at bedtime is recommended. NK1 
receptor antagonists (fosaprepitant and aprepitant) may be administered.
Diarrhea
Loperamide should be administered at the onset of treatment-related diarrhea at an initial dose of 
4 mg, followed by 2 mg with every episode of diarrhea to a maximum dose of 16 mg/day. If 
diarrhea is not resolved after 24 hours, add diphenoxylate/atropine or opium tincture as clinically 
indicated. Add octreotide 100 to 150 μg subcutaneously 3 times per day if diarrhea persists. For 
Grade 4 diarrhea, consider patient hospitalization and treatment with IV fluids and octreotide.
Antibiotics can be administered as clinically indicated.
Dietary modification should be recommended for the management of diarrhea, including a bland 
diet, small frequent meals, adequate fluid intake of clear liquids to maintain hydration, and 
discontinuation of lactose-containing foods and drinks containing alcohol.
Patients who exhibit an excessive cholinergic response to treatment with sacituzumab govitecan 
(eg, abdominal cramping, diarrhea, salivation) can receive appropriate premedication (eg, 
atropine) for subsequent treatments.

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7.8.3.2.
Neutropenia
Sacituzumab govitecan can cause severe or life-threatening neutropenia. Fatal infections in the 
setting of neutropenia have been observed in clinical trials. Grade 3 or higher neutropenia has 
been reported in 49% of patients and the median time to first onset of neutropenia (including 
febrile neutropenia) was 16 days. 
•
Sacituzumab govitecan should be withheld for ANC < 1500/mm3 on Day 1 of any cycle or 
neutrophil count < 1000/mm3 on Day 8 of any cycle and neutropenic fever.
•
Dose modifications of Sacituzumab govitecan may be required due to neutropenia 
(see Section 5.15 and Table 16). Administer G-CSF as clinically indicated.
•
Prophylactic use (primary and secondary) of G-CSF is not mandated but is highly 
recommended for patients at risk for high grade neutropenia and febrile neutropenia.

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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
The objectives and endpoints are provided in Section 2.
8.2.
Planned Analyses
8.2.1.
Dose-Determination Analysis
For the purposes of making the dose de-escalation decisions for the Safety Run-in Cohorts, 
dose-determination analyses of relevant safety data focusing on DLTs and overall safety profile 
will be conducted by the sponsor after all patients have completed the required DLT assessment 
period as specified in Section 3.1.1. Safety assessments (eg, AEs, electrocardiogram, laboratory 
results) will be displayed by cohort to facilitate the dose de-escalation decisions.
8.2.2.
Primary Analysis
For the primary analysis, outstanding data queries will have been resolved or adjudicated as 
unresolvable, and the data will have been cleaned and finalized for the analysis.
For Phase 2 Cohort 1, the primary analysis of PFS will be conducted after every enrolled patient 
has a minimum of 6 months follow-up. For Cohort 2 (Safety Run-in Cohort 2 and Phase 2 
Cohort 2), the primary analysis of ORR will be conducted when all enrolled patients have 
approximately a minimum of 6 months follow-up.
8.2.3.
Final Analysis
The final analysis may 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 Cohorts
For Safety Run-in Cohorts, the primary analysis set for efficacy analysis is the modified 
Intent-to-Treat (ITT) Analysis Set, defined as all patients who received at least 1 dose of any 
study 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 ITT Analysis Set, 
defined as all randomized patients according to the treatment arm to which the patients are 
randomized, unless otherwise specified.
8.3.1.1.3.
Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2)
For Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2), the primary analysis set for 
efficacy analysis is the modified ITT Analysis Set, defined as all patients who received at least 
1 dose of study drug at the selected Phase 2 Cohort 2 dose level. Safety Run-in Cohort 2 and 
Phase 2 Cohort 2 will be pooled for the endpoint of confirmed ORR in Cohort 2.
8.3.1.2.
Safety
8.3.1.2.1.
DLT-Evaluable Analysis Set
For Safety Run-in Cohort 1, the primary analysis set for the DLT analysis is the DLT-Evaluable 
Analysis Set, defined as all patients who meet 1 of the following criteria in the DLT assessment 
period (defined as 28 days of the first dosing cycle for nab-paclitaxel or paclitaxel):
•
The patient experienced a DLT at any time after initiation of the first infusion of magrolimab.
•
The patient did not experience a DLT and completed at least 3 infusions of magrolimab 
(28-day cycle), and at least 2 doses of nab-paclitaxel or paclitaxel in Safety Run-in Cohort 1.
For Safety Run-in Cohort 2, the primary analysis set for the DLT analysis is the DLT-Evaluable 
Analysis Set, defined as all patients who meet 1 of the following criteria in the DLT assessment 
period (defined as 21 days of the first dosing cycle for sacituzumab govitecan):
•
The patient experienced a DLT at any time after initiation of the first infusion of magrolimab.
•
The patient did not experience a DLT and completed at least 2 infusions of magrolimab 
(21-day cycle), and at least 2 infusions of sacituzumab govitecan in Safety Run-in Cohort 2.
8.3.1.2.2.
Safety Run-in Cohorts
For the Safety Run-in Cohorts, the primary analysis set for safety analysis, except for DLTs, is 
the Safety Analysis Set, defined as all patients who received at least 1 dose of any study drug.
8.3.1.2.3.
Phase 2 Cohort 1
For Phase 2 Cohort 1, the primary analysis set for safety analyses is the Safety Analysis Set, 
defined as all randomized patients who received at least 1 dose of study drug, with treatment 
assignment designated according to the actual treatment received.

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8.3.1.2.4.
Phase 2 Cohort 2
For Phase 2 Cohort 2, the primary analysis set for safety analyses is the Safety Analysis Set, 
defined as all patients who received at least 1 dose of any study drug.
8.3.1.3.
Pharmacokinetics
The PK analysis will be conducted on the PK Analysis Set, defined as all patients who received 
any amount of magrolimab and have at least 1 measurable posttreatment serum concentration of 
magrolimab.
8.3.1.4.
Immunogenicity
The immunogenicity analysis will be conducted on the Immunogenicity Analysis Set, defined as 
all patients who received any amount of magrolimab and have at least 1 evaluable 
anti-magrolimab antibody test result.
8.3.1.5.
Biomarker
The biomarker analysis will be conducted on the Biomarker Analysis Set, defined as all patients 
who received any study drug and have at least 1 evaluable biomarker measurement available.
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, 95% CIs on the mean, median, minimum, and maximum. 
Summary tables for categorical variables will include: N, n, percentage, and 95% CIs on 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 arm 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. 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 non-normality, 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 treatment(s), tumor imaging for baseline 
response assessment, randomization stratification group (Phase 2 Cohort 1 only), and ECOG 
performance status.

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8.5.
Efficacy Analysis
8.5.1.
Primary Efficacy Endpoint Analysis
8.5.1.1.
Phase 2 Cohort 1
For Phase 2 Cohort 1, PFS by investigator assessment will be analyzed using KM methods. 
Patients who did not have documented disease progression or death will be censored at the date 
of their last response assessment during the study with documentation of no disease progression. 
The KM estimate of the survival function will be computed, and the results will be presented 
using KM curves. The median will be provided along with the corresponding 95% CI. A 
log-rank test may be used to compare treatment difference in PFS. A Cox proportional hazard 
regression model may be used to estimate the HR and its 2-sided 95% CI.
8.5.1.2.
Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2)
For Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2) patients who are dosed at the 
selected Phase 2 Cohort 2 dose level, confirmed ORR by investigator assessment with 95% CI 
based on the Clopper-Pearson method will also 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
Analysis of OS and DOR by investigator assessment for Phase 2 Cohort 1 and OS, DOR by 
investigator assessment, and PFS by investigator assessment for Cohort 2 (Safety Run-in 
Cohort 2 and Phase 2 Cohort 2) will be similar to the primary endpoint analysis of PFS by 
investigator assessment for Phase 2 Cohort 1.
Confirmed ORR by investigator assessment for Phase 2 Cohort 1 along with the 95% CI will be 
estimated based on the Clopper-Pearson method for each treatment group. The chi-square test 
may be used to compare treatment difference in ORR. Odds ratios and corresponding 95% CIs 
will also be presented.
8.6.
Safety Analysis
8.6.1.
Primary Safety Endpoint Analysis
For the Safety Run-in Cohorts, the incidence of DLTs, AEs, and laboratory abnormalities during 
the DLT assessment period by count and percentage will be reported using the DLT-Evaluable 
Analysis Set. The DLT assessment period for Safety Run-in Cohort 1 is defined as the first 
dosing cycle of 28 days. The DLT assessment period for Safety Run-in Cohort 2 is defined as the 
first dosing cycle of 21 days.

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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 + 30 days or the day before initiation of new anticancer therapy, 
whichever is earlier, will be summarized by cohort and treatment arm (according to the study 
drug received). Data for the pretreatment and treatment-free safety follow-up periods will be 
included in data listings. For categorical safety data, including incidence of AEs and 
categorizations of laboratory data, counts and percentages of patients will be summarized. For 
continuous safety data, including laboratory data, number of patients, mean, SD, minimum, 
quartiles, median, and maximum will be summarized.
8.6.3.
Extent of Exposure
Data regarding a patient’s extent of exposure to study drugs 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 MedDRA. System organ class, high-level 
group term, high-level term, preferred term, and lower-level term will be attached to the clinical 
database.
Events will be summarized on the basis of the date of onset for the event. Treatment-emergent 
adverse events will be defined any AEs with an onset date on or after the date of the first dose of 
study treatment up to 30 days after the date of the last dose of study treatment, or the day before 
initiation of subsequent anticancer therapy, whichever comes first.
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. 
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 after baseline up to and including the date of last 
dose of any study drug + 30 days or the day before initiation of new anticancer therapy, 
whichever is earlier, will be summarized by cohort and treatment group. If baseline data are 
missing, then any graded abnormality (ie, at least a 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 after the day before initiation of new 
anticancer therapy will be included in a data listing.

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8.6.6. 
Other Safety Evaluations 
Final 
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Vital signs and physical examination findings will be summarized by cohort and treatment 
group. Details will be provided in the statistical analysis plan. 
8.7. 
Pharmacokinetic Analysis 
The PK Analysis Set will be used for summaries of PK concentrntion 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 individual sernm concentrntion versus 
time and mean concentrntion versus time by treatment will be generated. All data from this study 
may be combined with PK data from other company sponsored clinical studies and analyzed 
using a population PK model. Such an analysis would be repo1ted 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 
• • 
• 
• 
. 
. 
8.9. 
Biomarker Analysis 
The baseline level, absolute level, and change from baseline level over time will be summarized 
using descriptive statistics for each biomarker at sam le collection time oint b coho1t and 
treatment ann as a ro riate. 
8.10. 
Analysis of Patient-Reported Outcome Data 
Summa1y statistics and the mean change from baseline of linear-transfonned scores will be 
repo1ted for all of the items and subscales of the EORTC-QLQ-C30, EORTC-QLQ-BR23, and 
EQ-5D-5L questionnaires at each time point for Coho1t 1 only. In addition, mean scores for 
global health status, physical functioning, and selected symptom scales will be presented. The 
scores will be derived according to the EORTC scoring manual guidelines. 
8.11. 
Sample Size 
Based on the original design, for Phase 2 Cohort 1, using an unstratified log-rank test, a total of 
63 PFS events provides 82% power at a I-sided alpha of 0.15 to detect a HR of 0.61 (assuming 
median PFS of at least 9 months compared to a control aim median PFS of 5.5 months). 
Assuming an accrnal period of 15 months, a minimum follow-up time of 6 months, and a 5% 
annual drop-out rate, 92 patients ( 46 patients per aim) would be required to obtain 63 events. 
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Due to the early closure of Phase 2 Cohort 1, 28 patients have been enrolled and randomized for 
Arm A and Arm B. The analysis of the PFS given the current sample size is under powered and 
will be descriptive only.
For Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2), patients treated at the selected 
Phase 2 Cohort 2 dose level, using chi-square test, a total of 46 patients (including 6 patients in 
Safety Run-in Cohort 2 and 40 patients in Phase 2 Cohort 2) provides 88% power at a 1-sided 
alpha of 0.15 to detect an ORR of 50% compared with a null ORR of 34%.
Power calculations were performed using EAST 6.5.
8.12.
Gilead Data Review Committee
An internal GDRC will be established to assess the safety of patients in Phase 2 Cohort 1 Arm A 
and Phase 2 Cohort 2. The GDRC will perform interim reviews of safety data and monitor for 
treatment-related toxicities as per the prespecified stopping rules in Section 3.1.2.1. Further 
details of the GDRC’s specific activities will be defined in the GDRC charter, as well as the 
GDRC’s membership, conduct, and meeting schedule.

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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with International Council 
for Harmonisation (ICH) E6(R2) addendum to its guideline for Good Clinical Practice and 
applicable laws and regulations.
9.1.2.
Financial Disclosure
The investigator and subinvestigators will provide prompt and accurate documentation of their 
financial interest or arrangements with Gilead, or proprietary interests in the study drug during 
the course of a clinical study. This documentation must be provided prior to the investigator’s 
(and any subinvestigator’s) participation in the study. The investigator and subinvestigator agree 
to notify Gilead of any change in reportable interests during the study and for 1 year following 
completion of the study. Study completion is defined as the date when the last patient completes 
the protocol-defined activities.
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval
The investigator (or Gilead as appropriate according to local regulations) will submit this 
protocol, ICF, and any accompanying material to be provided to the patient (such as 
advertisements, patient information sheets, or descriptions of the study used to obtain informed 
consent) to an IRB/IEC. The investigator will not begin any study patient activities until 
approval from the IRB/IEC has been documented and provided as a letter to the investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC any modifications made to the protocol or any accompanying material to be 
provided to the patient after initial IRB/IEC approval, with the exception of those necessary to 
reduce immediate risk to study patients.
9.1.4.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study before undertaking any study-related procedures. The investigator 
must use the most current IRB- or IEC-approved ICF for documenting written informed 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 
impartial witness (if required by IRB or IEC or local requirements).

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The ICF will inform patients about genomic testing and/or planned sample retention. In addition 
to the study-specific ICF to be signed by each patient participating in the study, patients will be 
required to document agreement to allow the use of the remainder of their already collected 
specimens for 
 future research, in accordance with applicable regulations. The results of 
the tests performed on the samples will not be given to the patient or the investigator.
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])
CCI-

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•
Documentation of the reason(s) a consented patient is not enrolled
•
Participation in study (including study number)
•
Study discussed and date of informed consent
•
Dates of all visits
•
Documentation that protocol-specific procedures were performed
•
Results of efficacy parameters, as required by the protocol
•
Start and end date (including dose regimen) of study drug, including dates of dispensing and 
return
•
Record of all AEs and other safety parameters (start and end date, 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 

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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 any interim time points or 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.
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 (CSR) will be prepared and provided to the regulatory agencies when 
applicable and in accordance with local regulatory requirements. Gilead will ensure that the 
report meets the standards set out in the ICH Guideline for Structure and Content of Clinical 
Study Reports (ICH E3). Note that an abbreviated report may be prepared in certain cases. For 
studies with sites in countries following the EU Regulation No. 536/2014, a CSR will be 
submitted within 1 year (6 months for pediatric studies, in accordance with Regulation [EC] 
No. 1901/2006) after the global end of study (as defined in Section 3.5).
Investigators in this study may communicate, orally present, or publish study data in scientific 
journals or other scholarly media in accordance with the Gilead clinical trial agreement.

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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.
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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Chao MP, Alizadeh AA, Tang C, Myklebust JH, Varghese B, Gill S, et al. Anti-CD47 antibody 
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Gradishar WJ, Anderson BO, Abraham J, Aft R, Agnese D, Allison KH, et al. Breast Cancer, 
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Rugo HS, Barry WT, Moreno-Aspitia A, Lyss AP, Cirrincione C, Leung E, et al. Randomized 
Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle 
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Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic 
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and Efficacy of the First-in-Class Anti-CD47 Antibody Magrolimab Combined 
With Azacitidine in MDS and AML Patients: Phase 1b Results [Presentation]. 
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Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med 
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Drug Conjugate: A Targeted Therapy to Treat Triple-Negative Breast Cancers. 
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Sikic BI, Padda SK, Shah SA, Colevas AD, Narayanan S, Fisher GA, et al. A first-in-human, 
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Troughton MC, Simmons LW, Langley C, Youssef M, Marques MB. A Novel Use of Human 
Platelet Concentrate to Resolve Interference of Anti-CD47 in Serologic Testing 
[IGT46]. Transfusion 2018;58 (S2):179A-80A.
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Anti-CD47 antibody-mediated phagocytosis of cancer by macrophages primes an 
effective antitumor T-cell response. Proc Natl Acad Sci U S A 2013;110 
(27):11103-8.
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trial of carboplatin compared with docetaxel in BRCA1/2 mutated and pre-
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of the phase III RECOURSE trial of trifluridine/tipiracil (TAS-102) versus 
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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) and Breast Cancer Module 
(EORTC-QLQ-BR23)
Appendix 7.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
Appendix 8.
Eastern Cooperative Oncology Group (ECOG) Performance Status
Appendix 9.
American Society of Clinical Oncology/College of American Pathologists 
Guidelines
Appendix 10.
Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1)
Appendix 11.
UGT1A1 Inducers and Inhibitors
Appendix 12.
Country-Specific Requirements
Appendix 13.
Amendment History

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Appendix 1.
Investigator Signature Page
GILEAD SCIENCES, INC.
333 LAKESIDE DRIVE
FOSTER CITY, CA 94404
STUDY ACKNOWLEDGMENT
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally 
Advanced or Metastatic Triple-Negative Breast Cancer
GS-US-586-6144 Amendment 6; 30 January 2024
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.
Safety Run-in Cohort 1 and Phase 2 Cohort 1: Schedule of Assessments–Screening and Treatment Period
Cycle (28-day cycles)
1a
2a
3+a
Visit Window (Days)
None
± 3b, c
± 3b
± 3b
Cycle Day
Screening
Day −30 
to −1
1
2
8
15
22
1
8
15
22
1
8
15
Informed consent
X
Demographics
X
Medical and cancer history
X
ECOG
X
X
X
X
Vital signs, height, and weightd, e
X
X
X
X
X
X
X
X
X
X
X
X
Physical examinatione, f
X
X
X
X
X
X
X
X
X
ECG (single)g
X
Pregnancy testb, h
X
X
X
X
PD-L1i
X
Histologyj
X
Hematologyb, c, e
X
Xc
X
Xc
X
X
X
X
X
X
X
X
X
Haptoglobin and LDHb
X
X
X
Serum or plasma chemistryb, e
X
X
X
X
X
X
X
X
X
X
X
X
Coagulationb, k
X
Extended RBC phenotyping/genotyping, type and screen (ABO/Rh), DAT
X
Urinalysisb,l
X
Tumor imagingm
X
X, 
Q8Wn
Tumor biopsy 
Refer to Appendix Table 4

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Cycle (28-day cycles)
1a
2a
3+a
Visit Window (Days)
None
± 3b, c
± 3b
± 3b
Cycle Day
Screening
Day −30 
to −1
1
2
8
15
22
1
8
15
22
1
8
15
Adverse eventso
X
Concomitant medications
X
Randomizationp
X
PRO assessmentq: EORTC-QLQ-C30, EORTC-QLQ-BR23,
and EQ-5D-5Lb (Phase 2 Cohort 1 only)
X
X
X
Receptor occupancy
Circulating tumor DNA
PBMC
Serum and plasma biomarkers
Whole blood RNA
Immunophenotyping assay
TCR sequencing
Stool microbiome
Genomic blood sample
Pharmacokinetics
Antidrug antibodies
Refer to Appendix Table 4
IRT registrationr
X
X
X
X
X
X
X
X
X
X
X
Premedication for magrolimabs
X
X
Magrolimabc, t
Xc
Xc
X
X
X
X
X
X
X
X
Nab-paclitaxel or paclitaxel
Xu
X
X
X
X
X
X
X
X
ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; AE = adverse event; aPTT = activated partial thromboplastin time; CT = computed tomography; 
DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EORTC-QLQ-C30 = European Organisation for Research and 
Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire; EORTC-QLQ-BR23 = European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire–Breast Cancer Module; EQ-5D-5L = 5-level EuroQol 5 dimensions; INR = international normalized ratio; IRT = interactive response technology; LDH = lactate 
dehydrogenase; MRI = magnetic resonance imaging; PBMC = peripheral blood mononuclear cell; PD-L1 = programmed cell death ligand 1; PK = pharmacokinetics; 

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PRO = patient-reported outcome; PT = prothrombin time; PTT = partial thromboplastin time; QW = once weekly; Q8W = every 8 weeks; RBC = red blood cell; 
RECIST = response evaluation criteria in solid tumors; Rh = Rhesus factor; RP2D = recommended Phase 2 dose; TCR = T-cell receptor
c
In cases of magrolimab repriming following a treatment delay (Section 5.7), efficacy, biomarker, PK, and immunogenicity assessments should follow the schedule of the 
assigned cycle number. Magrolimab dosing and the safety assessment should follow Cycle 1 (refer to Table 4 or Table 5 as appropriate), and then subsequently switch back to 
the next assigned cycle schedule. If repriming is required during Cycles 1 or 2, dosing and safety assessments should follow Cycle 1, then Cycle 2, and then begin 
maintenance from Cycle 3 onwards. If repriming is required during the maintenance phase (Cycle 3 onwards), magrolimab dosing and safety assessments should follow 
Cycle 1 and subsequent dosing should resume maintenance dosing at the next assigned cycle. Magrolimab should not be given on consecutive days. Refer to footnote (r) for 
premedication requirement.
d
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.
e
A complete blood count with differential, platelets, and reticulocytes will be conducted. 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 magrolimab doses. An additional hemoglobin measurement should 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).
f
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 Day 1 of each cycle.
g
Vital signs, physical examination, weight, hematology, and serum/plasma chemistry on Cycle 1 Day 2, Cycle 1 Day 22, and Cycle 2 Day 22 should only apply to patients 
receiving magrolimab.
h
Complete physical examination is to be performed at screening and symptom-directed physical examination is to be performed from Cycle 1 Day 1.
i
Sites in the United Kingdom should perform additional ECGs once per cycle for the first 3 cycles.
j
Serum pregnancy test will be conducted at screening. The Cycle 1 Day 1 pregnancy test does not need to be repeated if the screening pregnancy test was performed within the 
72 hours before study treatment administration. Urine or serum pregnancy tests will be conducted from Cycle 1 Day 1.
k
PD-L1 to be performed during screening, if a prior diagnostic PD-L1 test result is not available. Testing can be performed locally. If testing not available locally, assessment 
can be performed using central laboratory.
l
After the signing of the informed consent form, histological assessment and documentation of the tumor by local assessment may occur outside of the 30-day screening 
period.
m
The analytes to be tested are PT, INR, and aPTT (or PTT).
n
Reflex microscopic testing based on other abnormalities.
o
CT/MRI will be performed per Section 6.6. Per RECIST criteria, if a patient achieves an initial objective response (complete response or partial response) on imaging, an 
imaging assessment at least 4 weeks later is required for confirmed response. 
p
Visit window: ± 7 days.
q
During screening, collect all SAEs considered related to protocol-mandated procedures after signing of the informed consent form.
r
Randomization must occur within 30 days of signing informed consent. The first dose on Cycle 1 Day 1 must be within 3 days of randomization.
s
If the PRO 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.
t
IRT registration will be required for screening, enrollment/randomization, and when dispensing any study drug supplied by Gilead.
u
Premedication is required prior to the administration of the first 2 doses of magrolimab and in case of reintroduction with repriming. Premedication should include oral 
acetaminophen, oral or IV diphenhydramine, and IV dexamethasone, or comparable regimen before the initial 2 doses of magrolimab or in the case of repriming. 
v
Magrolimab will be administered first before nab-paclitaxel or paclitaxel. Patients to be monitored for 1-hour postinfusion during Cycle 1. Postinfusion monitoring should 
begin after the infusion is complete, but prior to administering nab-paclitaxel or paclitaxel. Postinfusion monitoring is not required for doses after Cycle 1 Day 22. The RP2D 
will be determined in Safety Run-in Cohort 1. The magrolimab dosing regimen is described in Table 4 for Safety Run-in Cohort 1 and Table 5 for Phase 2 Cohort 1. If 
repriming occurs prior to or during the first 2 cycles (8 QW), the patient will have a total of 8 repriming visits starting with 1 mg/kg of magrolimab, then follow the assigned 

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dose level (eg, 30 mg/kg) for 7 QW (which is Day 8 to Day 50 visits). If repriming occurs at Cycle 3 or onwards, the patient will have a total of 4 repriming visits starting 
with 1 mg/kg of magrolimab, then follow the assigned dose level (eg, 30 mg/kg) for 3 QW (Day 8 to Day 22 visits). Magrolimab repriming should follow Table 8. 
Note: In Safety Run-in Cohort 1 and Phase 2 Cohort 1, if the magrolimab dose is 30 mg/kg from Cycle 3+, magrolimab is not administered on Day 8; refer to 
Table 4 and Table 5, respectively.
w
For patients receiving magrolimab in combination with paclitaxel/nab-paclitaxel, Cycle 1 Day 1 treatment can be administered over 2 days such that magrolimab is 
administered on Cycle 1 Day 1 and paclitaxel/nab-paclitaxel on Cycle 1 Day 2. This also applies to repriming cycles that require Cycle 1 Day 1 dosing of magrolimab. 
Cycle 1 Day 1 dosing and infusion time requirements for each agent should be followed, as listed in Table 4 and Table 5. Premedication guidelines should be followed prior 
to magrolimab (see Section 5.8), paclitaxel/nab-paclitaxel (see Section 5.11). Patients should be observed during and following the infusion for signs or symptoms of 
infusion-related reactions (see Section 5.6 for magrolimab and Section 5.10 for paclitaxel/nab-paclitaxel).
Note: Refer to Section 6.5, Safety Assessments, for complete list of analytes to be tested.

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Appendix Table 2.
Safety Run-in Cohort 2 and Phase 2 Cohort 2: Schedule of Assessments–Screening and Treatment Period
Cycle (21-day cycles)
1a
2a
3+a
Visit Window (Days)
None
± 3b, c
± 3b
± 3b
Cycle Day
Screening
Day −30 
to −1
1
2
8
15
1
8
15
1
8
Informed consent
X
Demographics
Xd
Medical and cancer history
Xd
ECOGd
Xd
X
X
X
Vital signs, height, and weighte
Xd
X
X
X
X
X
X
X
X
Physical examinationf
X
X
X
X
X
X
X
ECG (single)g
X
Pregnancy testb, h
Xd
X
X
X
PD-L1i
X
Histologyj
X
Hematologyb, c
Xd
Xc
X
Xc
X
X
X
X
X
X
Haptoglobin and LDHb
X
X
X
Serum or plasma chemistryb
Xd
X
X
X
X
X
X
X
X
Coagulationb, k
X
Extended RBC phenotyping/genotyping, type and screen 
(ABO/Rh), DAT
Xd
Urinalysisb, l
X
Tumor imagingm
Xd
X, 
Q6Wn
Tumor biopsy 
Refer Appendix Table 4
Adverse eventso
Xp
Concomitant medications
Xd

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Cycle (21-day cycles)
1a
2a
3+a
Visit Window (Days)
None
± 3b, c
± 3b
± 3b
Cycle Day
Screening
Day −30 
to −1
1
2
8
15
1
8
15
1
8
Receptor occupancy
Circulating tumor DNA
PBMC
Serum and plasma biomarkers
Whole blood RNA
Immunophenotyping assay
TCR sequencing
Stool microbiome
Genomic blood sample
Pharmacokinetics
Antidrug antibodies
Refer to Appendix Table 4
IRT registrationq
X
X
X
X
X
X
X
X
Premedication for magrolimabr
X
X
Magrolimabc, s
Xc
Xc
X
X
X
X
X
Premedication for sacituzumab govitecan
X
X
X
X
X
X
Sacituzumab govitecan
Xt
X
X
X
X
X
ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; AE = adverse event; aPTT = activated partial thromboplastin time; CT = computed tomography; 
DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; INR = international normalized ratio; IRT = interactive response 
technology; LDH = lactate dehydrogenase; MRI = magnetic resonance imaging; PBMC = peripheral blood mononuclear cell; PD-L1 = programmed cell death ligand 1; 
PK = pharmacokinetics; PT = prothrombin time; PTT = partial thromboplastin time; QW = once weekly; Q6W = every 6 weeks; RBC = red blood cell; RECIST = response 
evaluation criteria in solid tumors; Rh = Rhesus factor; RP2D = recommended Phase 2 dose; TCR = T-cell receptor.
a
In cases of magrolimab repriming following a treatment delay (Section 5.7), efficacy, biomarker, PK, and immunogenicity assessments should follow the schedule of the 
assigned cycle number. Magrolimab dosing and the safety assessment should follow Cycle 1 (refer to Table 6 or Table 7 as appropriate), and then subsequently switch back to 
the next assigned cycle schedule. If repriming is required during Cycles 1 or 2, dosing and safety assessments should follow Cycle 1, then Cycle 2 and begin maintenance 
from Cycle 3 onwards. If repriming is required during the maintenance phase (Cycle 3 onwards), magrolimab dosing and safety assessments should follow Cycle 1 and 
subsequent dosing should resume maintenance dosing at the next assigned cycle. Magrolimab should not be given on consecutive days. Refer to footnote (q) for 
premedication requirement.

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b
Pretreatment assessments are to be collected within 24 hours (hemoglobin for the first 2 magrolimab doses per Section 7.8.1.2) and within 3 days (safety labs) prior to any 
study treatment administration.
c
A complete blood count with differential, platelets, and reticulocytes will be conducted. 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 magrolimab doses. An additional hemoglobin measurement should 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).
d
Assessment results for patients enrolled in Cohort 1 Arm B with documented progressive disease that rescreen to enroll in Cohort 2 can be used for screening, if within the 
required screening period.
e
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 Day 1 of each cycle.
f
Complete physical examination is to be performed at screening and symptom-directed physical examination is to be performed from Cycle 1 Day 1.
g
Sites in the United Kingdom should perform additional ECGs once per cycle for the first 3 cycles.
h
Serum pregnancy test will be conducted at screening. The Cycle 1 Day 1 pregnancy test does not need to be repeated if the screening pregnancy test was performed within the 
72 hours before study treatment administration. Urine or serum pregnancy tests will be conducted from Cycle 1 Day 1.
i
PD-L1 to be performed during screening, if a prior diagnostic PD-L1 test result is not available. Testing can be performed locally. If testing not available locally, assessment 
can be performed using central laboratory.
j
After the signing of the informed consent form, histological assessment and documentation of the tumor by local assessment may occur outside of the 30-day screening 
period.
k
The analytes to be tested are PT, INR, and aPTT (or PTT).
l
Reflex microscopic testing based on other abnormalities.
m
CT/MRI will be performed per Section 6.6. Per RECIST criteria, if a patient achieves an initial objective response (complete response or partial response) on imaging, an 
imaging assessment at least 4 weeks later is required for confirmed response.
n
Every 6 weeks through 36 weeks (Weeks 6, 12, 18, 24, 30, and 36), then every 9 weeks. Visit window: ± 7 days.
o
During screening, collect all SAEs considered related to protocol-mandated procedures after signing of the informed consent form.
p
For patients enrolled in Cohort 1 Arm B with documented progressive disease that rescreen to enroll in Cohort 2, AEs should be reported under their Cohort 1 patient ID until 
they receive the first treatment dose in Cohort 2, and ongoing AEs from Cohort 1 should be captured as medical history.
q
IRT registration will be required for screening, enrollment/randomization, and when dispensing any study drug supplied by Gilead.
r
Premedication is required prior to the administration of the first 2 doses of magrolimab and in case of reintroduction with repriming. Premedication should include oral 
acetaminophen, oral or IV diphenhydramine, and IV dexamethasone, or comparable regimen before the initial 2 doses of magrolimab or in the case of repriming. 
s
Magrolimab will be administered first before sacituzumab govitecan. Patients to be monitored for 1-hour postinfusion during Cycle 1. Postinfusion monitoring should begin 
after the infusion is complete, but prior to administering sacituzumab govitecan. Postinfusion monitoring is not required for doses after Cycle 1 Day 15. The RP2D will be 
determined in Safety Run-in Cohort 2. The magrolimab dosing regimen is described in Table 6 for Safety Run-in Cohort 2 and Table 7 for Phase 2 Cohort 2. If repriming 
occurs prior to or during the first 2 cycles (6 QW), the patient will have a total of 6 repriming visits starting with 1 mg/kg of magrolimab, then follow the assigned dose level 
(eg, 30 mg/kg) for 5 QW (which is Day 7 to Day 36 visits). If repriming occurs at Cycle 3 or onwards, the patient will have a total of 3 repriming visits starting with 1 mg/kg 
of magrolimab, then follow the assigned dose level (eg, 30 mg/kg) for 2 QW (Day 8 to Day 15 visits). Magrolimab repriming should follow Table 9. 
t
For patients receiving magrolimab in combination with sacituzumab govitecan, Cycle 1 Day 1 treatment can be administered over 2 days such that magrolimab is 
administered on Cycle 1 Day 1 and sacituzumab govitecan on Cycle 1 Day 2. This also applies to repriming cycles that require Cycle 1 Day 1 dosing of magrolimab. Cycle 1 
Day 1 dosing and infusion time requirements for each agent should be followed, as listed in Table 6 and Table 7. Premedication guidelines should be followed prior to 
magrolimab (see Section 5.8) and sacituzumab govitecan (see Section 5.14). Patients should be observed during and following the infusion for signs or symptoms of 
infusion-related reactions (see Section 5.6 for magrolimab and Section 5.13 for sacituzumab govitecan).
Note: Refer to Section 6.5, Safety Assessments, for complete list of analytes to be tested.

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Appendix Table 3.
Schedule of Assessments–Posttreatment
EOT Visit
Safety 
Follow-up 
Visit/Call
(Telephone)a
Pre-Progression 
Visitb
Survival Follow-up
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
Visit Window
± 7 Days
± 7 Days
± 7 Days
Urine or serum pregnancy testc
X
X
X
Hematologyd 
X
Serum or plasma chemistry
X
Pharmacokinetics
Antidrug antibodies 
Refer to Appendix Table 4
Tumor imaging for response 
assessmente
X
X
ECOG
X
Vital signs 
X
Symptom-directed physical 
examination
X
ECG (UK sites only)
X
PRO assessmentf
X
Receptor occupancy
Circulating tumor DNA
Serum and plasma biomarkers
Whole blood RNA
Refer to Appendix Table 4
Adverse eventsg
X
X
Concomitant medications
X
X
New anticancer therapy
X
X
Xh
Survival follow-up
Every 2 monthsi
AE = adverse event; CT = computed tomography; ECOG = Eastern Cooperative Oncology Group; EOT = end of treatment; 
MRI = magnetic resonance imaging; PRO = patient-reported outcome; SAE = serious adverse event
a
If the patient experiences a treatment-related AE or an SAE (regardless of attribution), the patient must be asked to come to 
the site.
b
This will only apply for patients who stop study treatment in the absence of disease progression per RECIST, Version 1.1 
and will continue to have tumor imaging. See footnote (e) for details on tumor imaging schedule. Pre-progression visits will 
be completed first before proceeding to survival follow-up.
c
Pregnancy testing will continue monthly up to 6 months after the EOT per the duration of required contraception as 
discussed in Appendix 5. Testing during survival follow-up may be done at home and the result self-reported by the patient.
d
A complete blood count with differential, platelets, and reticulocytes will be conducted.

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e
Tumor imaging at EOT visit not required if performed within the last 30 days or progressive disease per RECIST, 
Version 1.1 has been documented. CT/MRI will be performed per Section 6.6. For patients who stop study treatment in the 
absence of disease progression per RECIST, Version 1.1 (eg, experienced unexpected toxicity), scans should continue to be 
collected approximately every 8 weeks (28-day dosing cycle) for Cohort 1 patients and every 9 weeks (21-day dosing cycle) 
for Cohort 2 patients until disease progression or initiation of systemic antitumor therapy other than the study treatment, 
whichever is earlier.
f
PRO assessments will be conducted for patients in Phase 2 Cohort 1 only. If the PRO 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.
g
Report all AEs through the Safety Follow-up Visit/Call, and any treatment-related SAEs thereafter.
h
Collect new anticancer therapy data following the last dose of study treatment until the end of survival follow-up.
i
Survival follow-up will be conducted via a phone call every 2 months until death or end of study. Duration of survival 
follow-up will be limited to 3 years.

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Appendix Table 4.
Cohort 1 and Cohort 2: Schedule of Assessments–Pharmacokinetic, Antidrug Antibodies, and Biomarker
Cycle 1
Cycle 2
Cycle 3
Cycle 4
Cycle 5
Cycle 7
Cycle 10
Cycle 13
EOT
Cycle Day
Screening
Day −30 
to −1
1
8
15
1
1
1
1
1
1
1
PKa
X
X
X
Xb
X
X
X
X
X
Antidrug antibodiesc
X
X
X
X
X
X
X
X
Receptor occupancyd
X
X
X
X
X
X
X
X
Circulating tumor DNAe
Xf
X
X
X
X
X
X
PBMCg
X
X
X
X
TCR sequencingg
X
X
X
X
Immunophenotyping assayg
X
Xh
X
X
Serum and plasma biomarkersi
X
Xh
X
X
X
X
X
Whole blood RNAi
X
Xh
X
X
X
X
X
Stool microbiomej
X
Genomic blood samplek
X
Tumor biopsy
Xl
Xm
ADA = antidrug antibodies; EOT = end of treatment; PBMC = peripheral blood mononuclear cell; PK = pharmacokinetic; RO = receptor occupancy; TCR = T-cell receptor
a
PK samples will be collected from patients who are assigned to receive magrolimab. PK samples are to be collected predose within 12 hours prior to the first administration of 
magrolimab given in Cycles 1, 2, 3, 5, 7, 10, 13, and on Cycle 1 Day 8, and at the EOT.
b
In Cycle 3, PK samples are to be collected predose (within 12 hours) and postdose at 1 hour (± 15 min) after the end of the infusion of the first administration of magrolimab 
given.
c
ADA samples will be collected from patients who are assigned to receive magrolimab. ADA samples are to be collected prior to the administration of magrolimab at the same 
time as the predose PK samples in Cycles 1, 2, 3, 5, 7, 10, 13, and at the EOT.
d
RO samples will be collected from patients who are assigned to receive magrolimab. RO samples are to be collected predose within 12 hours prior to administration of 
magrolimab on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15, predose within 12 hours prior to the first administration of magrolimab given in Cycles 3, 4, 5, and 10, 
and at EOT, if occurring before Cycle 10. RO samples will be collected at select sites only.
e
Samples will be collected at screening and predose within 12 hours prior to the administration of any study drug on Cycle 1 Day 1 and Cycle 1 Day 15, predose within 
12 hours prior to the first administration of any study drug given in Cycles 3, 4, and 7, and at EOT (regardless of time of occurrence).
f
Assessment results for patients enrolled in Cohort 1 Arm B with documented progressive disease that rescreen to enroll in Cohort 2 can be used for screening if within the 
required screening period.

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g
Samples will be collected predose within 12 hours prior to administration of any study drug on Cycle 1 Day 1 and Cycle 1 Day 8, and predose within 12 hours prior to the first 
administration of any study drug given in Cycles 2 and 3. PBMC and immunophenotyping will be collected at select sites only.
h
For patients receiving magrolimab, an additional sample for serum and plasma biomarkers, whole blood RNA, and immunophenotyping assay will be collected 4 hours after 
the start of magrolimab administration on Cycle 1 Day 8.
i
Samples will be collected predose within 12 hours prior to administration of any study drug on Cycle 1 Day 1 and Cycle 1 Day 8, predose within 12 hours prior to the first 
administration of any study drug given in Cycles 2, 3, 4, and 7, and at EOT if occurring before Cycle 7.
j
Stool microbiome to be collected predose on or before Cycle 1 Day 1.
k
The genomic blood sample can be collected at Cycle 1 Day 1 or at any time during the study. Patients enrolled in Cohort 1 Arm B with documented progressive disease that 
rescreen to enroll in Cohort 2 do not need to submit a new sample under Cohort 2 patient ID. 
l
For patients enrolled in Cohort 1 Arm B with documented progressive disease that rescreen to enroll in Cohort 2, a new tumor biopsy at the time of rescreening should be 
obtained fresh whenever possible. Alternatively, tissue from on-treatment biopsy submitted as part of Cohort 1 assessments can be accepted, if available.
m
On-treatment tumor biopsy can be collected any time between Cycle 3 Day 1 and Cycle 4 Day 1.

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Appendix 3.
Pandemic Risk Assessment and Mitigation Plan
During an ongoing pandemic, potential risks associated with patients being unable to attend 
study visits have been identified for this study.
These potential risks and mitigation plans can be summarized as follows:
1) Schedule of assessments:
a) Physical examination:
In order to limit a patient’s time in the clinic, a virtual visit may be conducted for the 
physical examination assessment. Vital signs may be omitted for virtual visits. However, 
dosing and biological sample collection should occur per protocol in the clinic.
b) Dosing:
Patients may be unable to return to the site for a number of visits to receive the study 
drug, or the site may be unable to accept any patient visits. Without study drugs, the 
patient would not be able to stay on the study drug as planned per protocol.
Mitigation plan: If permitted by local ethics committee/institutional review boards 
noninvestigational product as determined by sponsor (ie, nab-paclitaxel or paclitaxel) can 
be administered at a clinic closer to the patient, under the supervision of a licensed 
physician. If necessary, a dosing delay for magrolimab must be discussed with the 
sponsor in this instance. A virtual study visit, via phone or video conferencing, must be 
performed prior to remote dosing. At the earliest opportunity, the site will schedule 
in-person patient visits and return to the protocol’s regular schedule of assessments. A 
qualified courier may be considered to ship the drug from sites to the alternate clinic.
c) General patient selection guidance:
To minimize patients receiving red blood cell transfusions, we recommend selecting 
patients with higher hemoglobin thresholds at baseline and use intravenous iron and/or 
erythropoietin where clinically indicated.
2) Study drug supplies to patients and sites:
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 infection will be based 
on local clinical guidelines for testing based on signs/symptoms and or suspected 
exposure to COVID-19.

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Mitigation plan: If patient has a diagnosis of COVID-19 while on this clinical study, 
study drugs may be held until clinical improvement or resolution in accordance with the 
treating physician’s judgment and general magrolimab dose delay guidance in the 
protocol. Additional supportive care and treatment measures for COVID-19 infection on 
the study will be performed in accordance with local institutional guidelines. Patients 
with a COVID-19 infection while participating in a clinical study will have this event 
documented as an adverse event 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 which 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 at least 54 years of age 
with cessation of previously occurring menses for at least 12 months without an alternative 
cause. In addition, women of less than 54 years of age with amenorrhea of at least 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 nonclinical data. For 
magrolimab, there is no anticipated pharmacokinetic interaction with progestin or other steroids 
based on the distinct clearance pathways.
Based on the MOA and findings in animals, nab-paclitaxel or paclitaxel can cause fetal harm 
when administered to a pregnant woman. There is no contraindication to hormonal contraception 
according to the nab-paclitaxel or paclitaxel prescribing information.
Sacituzumab govitecan is contraindicated in pregnancy because a malformative effect has been 
demonstrated/suspected or is unknown, taking into consideration class effects, and genotoxic 
potential. Based on the assessment of published data related to cytochrome P450 enzyme 
inhibition and induction experiments for SN-38, efficacy of hormonal contraception is not 
expected to be impacted due to sacituzumab govitecan administration. A dedicated oral 
contraceptive drug-drug interaction clinical study has not been conducted. Refer to the latest 
version of the investigator’s brochure for additional information.

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b.
Contraception Requirements for Female Patients of Childbearing Potential
The inclusion of female patients of childbearing potential requires the use of highly effective 
contraceptive measures with a failure rate of less than 1% per year. They must have a negative 
serum pregnancy test at screening and a negative pregnancy test is required prior to study 
treatment administration on Cycle 1 Day 1. The Cycle 1 Day 1 pregnancy test does not need to 
be repeated if the screening pregnancy test was performed within the 72 hours before study 
treatment administration. Pregnancy tests will be performed at the beginning of each 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 
screening visit until 6 months after last dose of the latest administered study drug.
Female patients must agree to one of the following contraceptive methods:
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the patient’s preferred and usual lifestyle.
Or
•
Consistent and correct use of 1 of the following methods of birth control listed below:
Nonhormonal intrauterine device (IUD)
Hormonal IUD (must be used in conjunction with a barrier method)
Bilateral tubal occlusion (upon medical assessment of surgical success)
Vasectomy in the male partner (upon medical assessment of surgical success)
Or
Female patients who wish to use a hormonally based method must use it in conjunction with a 
barrier method, preferably a male condom. Hormonal methods are restricted to those associated 
with the inhibition of ovulation. Hormonally based contraceptives and barrier methods permitted 
for use in this protocol are as follows:
•
Hormonal methods (each method must be used with a barrier method, preferably male 
condom)
Oral contraceptives (either combined or progesterone only)
Injectable progesterone
Transdermal contraceptive patch
Contraceptive vaginal ring
Subdermal contraceptive implant

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

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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 sacituzumab govitecan cohort 
(Cohort 2) in this study (throughout the study or for 3 months after the last dose of sacituzumab 
govitecan, whichever is longer); 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) and Breast Cancer Module 
(EORTC-QLQ-BR23)
https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-QLQ-C30-English.pdf 
https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-BR23-English-1.1.pdf 

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Appendix 7.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) 
Hlealth Questionnialre 
English version for the UK 

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Under each heading, plea,se tick lhe ONE box hat best describes your heallh TODAY. 
MOBILITY 
I have no problems In walking about 
I have sllgttl probtems in walk ng about 
I have moderate pr,oi, ems In walking about 
I have severe problems in walking albou 
I am 1.ma bte lo• walk aboul 
SELIF-CARE 
I have no problems w-ashing or dressing1 myself 
I have Slig1h1 probl:ems wa.Shing or dreSSing1 myself 
I have moderate problems wasll'linig or d es.sing myself 
I have severe problems wash ng or dres.slm1 myself 
I am unable l.o• wasl'l or dress myself 
USUAL .ACTIVITIES, (e_g_ work. study, housework. family or 
leisure activities) 
I have no problems doing my usual acliYilies 
I have slighl problems doir1g my usual aclivilies 
I have moderate pmb.lems doing my usu.a I activities 
I have severe problems ,doing my usuall activities 
I :am unable 1.0 do, my usual activities 
IPAIN I DISCOMFORT 
I have no paim or discomfort 
I have sllghl pa n or discomfort 
I have moderate pain or dls.comrort 
I have severe pain or ,diSIOOmfort 
I have e;xtreme pain or discomfort 
ANXIETY / D:EPiRESSIO:N 
I am not ain:icious or dep:ressed 
I am Sliglnlly an:icious or depressed 
I am moderately anxiou,s or,depr,essed 
I am severe!¥ anxious or,de:pres-sed 
I am extreme•IY arn,:ious or de presse·d 
2 

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• 
We wo,uJd like to !know how good or bad your healltl is TODAY. 
•· This scal& Is number,&d 'from 0 to 100. 
•· 100 means Uie be-sl health you can imagine. 
0 means the·~ 
hei;illh you can imlilgine. 
• Mark an x on tile scale to indicate lilO"lv yo1Jr Fteattll iS, TODAY. 
• 
Now, please·wrile· Uie number you marked on Uie scale ill ~he bw,: 
betow. 
YOUR HEALTH TODAY a. D 
3 
The best ill!'alth 
vc,u can lmilgtne 
100 
95 
00 
ao 
75 
70 
60 
65 
45 
40 
35 
25 
20 
15 
10 
5 
I) 
The woro! healih 
you can imagine 

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Appendix 8.
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 housework, 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 9.
American Society of Clinical Oncology/College of American 
Pathologists Guidelines 

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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 for full RECIST guidelines.

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Appendix 11.
UGT1A1 Inducers and Inhibitors
Inducers of UGT1A1
Inhibitors of UGT1A1
Carbamazepine
Efavirenz 
Ethinylestradiol
Lamotrigine 
Phenobarbital
Phenytoin 
Primidone 
Rifampicin 
Ritonavir 
Tipranavir
Amitriptyline 
Atazanavir
Dacomitinib 
Dasabuvir 
Deferasirox 
Eltrombopag
Enasidenib 
Erlotinib
Flunitrazepam 
Flurbiprofen
Fostamatinib 
Gemfibrozil 
Glecaprevir 
Indinavir
Indomethacin 
Ketoconazole
Nilotinib
Ombitasvir 
Paritaprevir 
Pazopanib 
Pexidartinib 
Pibrentasvir 
Probenecid
Propofol 
Regorafenib 
Rucaparib 
Silibinin 
Sorafenib 
Valproic acid
UGT1A1 = uridine diphosphate glucuronosyltransferase 1A1

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Appendix 12.
Country-Specific Requirements 
Additional Country-Specific Requirements for United Kingdom (UK)
Country-specific Requirements
Protocol Section
Patients with a history of noninfectious pneumonitis or patients with current 
pneumonitis are excluded. Patients who must continue therapies that are prohibited 
while receiving paclitaxel or nab-paclitaxel are excluded.
Synopsis, Section 4.3
To increase cardiac monitoring for paclitaxel-related events or the possibility of 
exacerbation of cardiac events due to magrolimab-related anemia, additional 
electrocardiogram assessments should be performed once per cycle for the first 
3 cycles and at the end of treatment.
Section 6.4.6
Additional Country-Specific Requirements for South Korea
Country-specific Requirements
Protocol Section
Patients in South Korea are not permitted to be transfused to meet eligibility criteria 
for hemoglobin.
Synopsis, Sections 4.2, 
4.3, and 7.8.1.2.

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Appendix 13.
Amendment History
High-level summaries of the history of this study’s amendments are provided in tabular form in 
the subsections below (from most recent amendment to oldest). 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 the Amendment 5 to this amendment 
will be made available upon the publication of this protocol.
Amendment 6 (30 January 2024)
Rationale for Key Changes Included in Amendment 6
Affected Sections
Clarified that due to early closure of Phase 2 Cohort 1, the primary analysis of 
Phase 2 Cohort 1 is no longer event driven but will occur once every enrolled 
patient has a minimum of 6 months follow-up.
Synopsis, Sections 3.1.2 and 
8.2.2
Updated the efficacy analysis in Phase 2 Cohort 1 due to underpowered sample 
size.
Synopsis, Section 8.5.1.1, 
Section 8.5.2
Updated the sample size justification in Phase 2 Cohort 1 to describe the current 
design on account of early closure of Phase 2 Cohort 1.
Synopsis, Study schema, 
and Section 8.11
Updated the methodology to allow the evaluation of probability of early stop of 
the study treatment at any given true toxicity rate. Threshold values have also 
been updated based on maximum acceptable toxicity rate of combination 
therapies. These changes have been made considering the trade-off between the 
early stoppage chance for the unacceptable rates of potential synergistic toxicities 
and the likelihood for early stoppage while true toxicity rate is acceptable.
Section 3.1.2.1
Removed the second Gilead Data Review Committee (GDRC) given the early 
closure of Phase 2 Cohort 1.
Section 3.1.2.1
Updated the sacituzumab govitecan (SG) administration window for Cycle 1 
Day 1 per SG content library and SG Pharmacy Manual update.
Table 7
Updated the number of patients enrolled in the study and Phase 2 Cohort 1
Synopsis, Section 4.1
Clarified that the final analysis may be performed but not required.
Section 8.2.3
Minor changes to correct typographic errors.
Throughout, as needed
Amendment 5 (30 October 2023)
Rationale for Key Changes Included in Amendment 5
Affected Sections
Clarification of timing of treatment-related toxicity monitoring.
Section 3.1.2.1
Clarification for continuation of study drug treatment in the event of disease 
progression.
Sections 3.3 and 3.4
Clarification of TNBC disease status and prior lines of therapy in Inclusion 
Criteria 12 and 15 and Exclusion criterion 20.
Synopsis, Sections 4.2 and 
4.3

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Rationale for Key Changes Included in Amendment 5
Affected Sections
Clarification of Exclusion Criterion 3 related to active CNS disease.
Synopsis, Section 4.3
Country-specific requirements and cross-references added to provide to specific 
guidance and requirements for sites in the United Kingdom and South Korea.
Synopsis, Section 4.3, 
Section 6.4.6, 
Appendix Tables 1, 2, and 
3, Appendix 12
Clarification of Exclusion Criterion 16 related to active uncontrolled infection.
Synopsis, Section 4.3
Clarification of exception to exclusion criteria related to patients with controlled 
hypo- or hyperthyroidism, or other endocrinopathies.
Synopsis, Section 4.3
Storage requirements for sacituzumab govitecan updated.
Section 5.5.3
Removed requirement for sponsor approval to withhold magrolimab for 
treatment-emergent and/or -related AEs. 
Section 5.7
Guidance for the use of corticosteroids as premedication for the first 2 doses of 
magrolimab or in the case of repriming provided.
Section 5.8, 
Appendix Tables 1, and 2
Guidance provided for use of granulocyte-colony stimulating factor as 
prophylaxis for neutropenia associated with sacituzumab govitecan.
Section 5.14, Table 15, and 
Section 5.15
Clarification of dose modification for sacituzumab govitecan and action to be 
taken in the case of severe neutropenia.
Table 16
Clarification of specific SAE collection between obtaining informed consent and 
first dose of study drug.
Section 6.2.2, Section 7.3.3, 
Appendix Tables 1 and 2
Clarification of criteria for pregnancy testing requirements.
Section 6.10, 
Appendix Table 3
Clarification of the timing of PRO instrument administration.
Section 6.4.7
Requirement of a brain MRI with contrast for all patients at screening added. 
Section 6.6
Clarification of disease progression criteria added.
Section 6.6, 
Appendix Table 3
Updated guidance provided for management of infusion-related reactions.
Section 7.8.1.3
Sections added for guidance on management of severe neutropenia and serious 
infections.
Sections 7.8.1.6 and 7.8.1.7
Section added for guidance on management of neutropenia.
Section 7.8.3.2
Findings from nonclinical study incorporated into pregnancy precaution guidance.
Appendix 5
Minor changes to correct typographic errors. 
Throughout, as needed

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Amendment 4 (07 March 2023)
Rationale for Key Changes Included in Amendment 4
Affected Sections
Secondary objectives and endpoints were updated to remove independent central 
review for objective response rate, progression-free survival, and duration of 
response assessments. 
Synopsis and Sections 2 
and 6.6
Requirement for prior lines of treatment updated to be more inclusive of patient 
population.
Synopsis, Study Schema, 
Section 3.1
Clarified assessments that can be utilized for screening.
Section 3.1
Optional prescreening collection added for sample collection.
Section 6.2.1
Clarification added for timing of drug administration for patients receiving 
combination therapy. 
Sections 3.2.2, 5.6, 5.10, 
and 5.13.1, 
Appendix Tables 1 and 2
Clarification added that patient-reported outcome assessments can be waived if 
there is a barrier to completion. 
Section 6.4.7, 
Appendix Tables 1 and 3
Circulating tumor cell sample collection was removed from biomarker 
assessment.
Section 3.8, 
Appendix Tables 1 and 2
Eligibility updated to allow patients enrolled in another trial who are not receiving 
a therapeutic intervention. 
Synopsis, Sections 4.1, 4.3, 
and 6.2.2, and 
Appendix Tables 2 and 4
Eligibility criteria updated for change in number of prior treatments allowed.
Synopsis, Section 4.2
Packaging and handling of sacituzumab govitecan updated to align with current 
practice.
Sections 3.2.2 and 5.5.3
Clarification added that patients do not need to come to clinic for certain 
assessments if not receiving magrolimab.
Appendix Table 1
Clarification added regarding sourcing and labeling of non-Gilead study 
medications.
Sections 5.3.2 and 5.4.2
Clarification added regarding repriming sequence of dosing and safety 
assessments.
Section 5.7 (Tables 8 and 9) 
and Appendix Tables 1 
and 2
Footnotes were removed from Tables 11, 12, 13 and 14 because there is no dose 
de-escalation of nab-paclitaxel and paclitaxel in the Safety Run-in Cohorts.
Sections 5.12.1, 5.12.2, 
5.12.3, and 5.12.5
Stool microbiome assessment removed for Cycle 3 Day 1. 
Appendix Table 4
Window for collection of safety data following study drug administration updated 
for initiation of new anticancer therapy. 
Section 8.6.2
Timing of the primary analysis updated for clarity. 
Section 8.2.2
Pregnancy test removed from survival follow-up to align with guidance from last 
treatment. 
Section 6.10, 
Appendix Table 3
Window for sacituzumab govitecan infusion for Cycle 1 Day 8 updated to match 
window for other infusion days. 
Section 3.2.1 
(Tables 6 and 7)
Timeframe between prior anticancer therapy and start of magrolimab updated. 
Synopsis, Section 4.3

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Rationale for Key Changes Included in Amendment 4
Affected Sections
Definition of uncontrolled hypercalcemia updated for clarity.
Synopsis, Section 4.3
Clarification was added regarding requirement of a new tumor biopsy at the time 
of rescreening for patients enrolled in Cohort 1 Arm B that rescreen to enroll in 
Cohort 2.
Section 6.9, 
Appendix Table 4
Requirements for collection prior to study drug initiation updated to align with 
current practice.
Section 7.3.1
Secondary efficacy endpoint analyses were updated in line with changes made in 
secondary objective and endpoints.
Section 8.5.2
Changes incorporated from Administrative Amendments 1 and 2 for Protocol 
Amendment 3.
Sections 6.2.2, 6.5 
(Table 17), and 6.6, and 
Appendix Table 1
Minor changes to correct typographic errors. 
Throughout, as needed
Separate tracked change (red-lined) documents comparing Amendment 3, Amendment 3.1-UK, 
and Amendment 3.2-KOR to this amendment may be made available upon the publication of this 
protocol.
Amendment 3.2-KOR (01 February 2023)
Rationale for Key Change Included in Amendment 3.2-KOR
Affected Sections
Patients in South Korea are not permitted to be transfused to meet the eligibility 
criteria for hemoglobin.
Synopsis, Sections 4.2, 4.3, 
and 7.8.1.2
Amendment 3.1-KOR (31 October 2022)
Rationale for Key Change Included in Amendment 3.1-KOR
Affected Sections
Correction of a typographical error in the synopsis, clarifying that the Safety 
Run-in Cohort 2 starting dose (after priming) is 60 mg/kg every 3 weeks.
Synopsis

Prot GS-US-586-6144 amd-6
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
31-Jan-2024
01:28:22
PPD