Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer (ELEVATE TNBC)

October 30, 2025 updated by: Gilead Sciences

A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with nab-paclitaxel or paclitaxel (cohort 1) or with sacituzumab govitecan-hziy (cohort 2) in participants with non-surgically removable locally advanced or metastatic triple-negative breast cancer.

The primary objective of this study for the safety run-in cohorts of the study is to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with nab-paclitaxel or paclitaxel (Safety Run-In Cohort 1), and sacituzumab govitecan (Safety Run-In Cohort 2) in metastatic triple-negative breast cancer (mTNBC).

This study in the Phase 2 Cohort 1 also compares 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.

This study in the Phase 2 Cohort 2 also evaluates the efficacy of magrolimab in combination with sacituzumab govitecan as determined by confirmed objective response rate (ORR) by investigator assessment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study for the safety run-in cohorts of the study is to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with nab-paclitaxel or paclitaxel (Safety Run-In Cohort 1), and sacituzumab govitecan (Safety Run-In Cohort 2) in metastatic triple-negative breast cancer (mTNBC).

The primary objective of this study for Phase 2 Cohort 1 is 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.

The primary objective of this study for Phase 2 Cohort 2 is to evaluate the efficacy of magrolimab in combination with sacituzumab govitecan as determined by confirmed objective response rate (ORR) by investigator assessment.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Cairns and Hinterland Hospital and Health Service
      • Sippy Downs, Queensland, Australia, 4556
        • University of the Sunshine Coast
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Cancer Research SA
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne
      • Frankston, Victoria, Australia, 3199
        • Peninsula Health
      • Geelong, Victoria, Australia, '03220
        • Barwon Health- University Hospital Geelong
      • Wendouree, Victoria, Australia, 3355
        • Ballarat Oncology & Haematology Services
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Kowloon, Hong Kong
        • Princess Margaret Hospital
      • New Territories, Hong Kong
        • Prince of Wales Hospital
  • South Korea
      • Gangnam-Gu, South Korea, 06351
        • Samsung Medical Center
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Jongrogu, South Korea, 110-744
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 5505
        • Asan Medical Center
  • Taiwan
      • Beitou District, Taiwan, 11257
        • Taipei Veterans General Hospital
      • Changhua, Taiwan, 50006
        • Changhua Christian Hospital
      • Guishan District, Taiwan, 131
        • Chang Gung Memorial Hospital, Linkou
      • Sanmin District, Taiwan, 80778
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Tapiei, Taiwan
        • National Taiwan University Hospital
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • University Hospitals of Leicester NHS Trust
      • London, United Kingdom, WC1E 6BT
        • University College London
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
    • California
      • Fresno, California, United States, 93710
        • Women's Cancer Care
      • Fullerton, California, United States, 92835
        • Providence Medical Foundation
      • San Francisco, California, United States, 94115
        • University of California San Francisco
      • Santa Monica, California, United States, 90404
        • Saint John's Cancer Institute
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center,LLC
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute Emory University
      • Newnan, Georgia, United States, 30265
        • Southeastern Regional Medical Center, LLC
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Orchard Healthcare Research Inc
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Allina Health Cancer Institute
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Astera Cancer Care
    • New York
      • New York, New York, United States, 10016
        • NYU Investigational Pharmacy, Laura & Isaac Perlmutter Cancer Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Oncology
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute, University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion criteria:

  • Adequate performance status, hematologic, renal and liver function.
  • Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
  • Cohort 1: Individuals with previously untreated with systemic therapy for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) that are considered programmed cell death ligand 1 (PD-L1) negative (as determined by an approved test according to local regulations).
  • Cohort 2: Individuals with unresectable, locally advanced or metastatic breast cancer with a diagnosis of TNBC who have received at least 1 and no more than 2 prior lines of systemic therapy in the unresectable, locally advanced or metastatic setting. Individuals must have been previously treated with a taxane in any setting. Individuals with tumors that are considered positive for PD-L1 expression (as determined by an approved test according to local regulations) must have received an immune checkpoint inhibitor for a prior-line of treatment for unresectable locally advanced/metastatic TNBC.

Key Exclusion Criteria:

  • Positive serum pregnancy test or breastfeeding female.
  • Active central nervous system (CNS) disease. Individuals 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.
  • Red blood cell (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.
  • History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
  • Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha-targeting agents.
  • Known inherited or acquired bleeding disorders.
  • Cohort 1 only: Disease progression within 6 months following neoadjuvant/adjuvant therapy.

  • Cohort 2 only:

    • Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and Individuals with a history of bowel obstruction or gastrointestinal perforation within 6 months of enrollment.
    • Individuals who previously received topoisomerase I inhibitors or antibody-drug conjugates containing a topoisomerase inhibitor.
    • High-dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Cycle 1 Day 1.

    • Have not recovered (ie, ≥ Grade 2 is considered not recovered) from adverse events (AEs) due to a previously administered agent.

      • Note: Individuals 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 individuals received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel or Paclitaxel

Participants will receive magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below:

  • Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-days cycle;
  • Nab-paclitaxel 100 mg/m^2 or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-days cycle.
Drug: Magrolimab
Administered intravenously
Other Names:
  • GS-4721
Drug: Paclitaxel
Administered intravenously
Other Names:
  • Taxol®
Drug: Nab-Paclitaxel
Administered intravenously
Other Names:
  • Abraxane
Experimental: Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel

Participants will receive magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below:

  • Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-days cycle;
  • Nab-paclitaxel 100 mg/m^2 or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-days cycle.
Drug: Magrolimab
Administered intravenously
Other Names:
  • GS-4721
Drug: Paclitaxel
Administered intravenously
Other Names:
  • Taxol®
Drug: Nab-Paclitaxel
Administered intravenously
Other Names:
  • Abraxane
Active Comparator: Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel

Participants will receive nab-paclitaxel IV or paclitaxel IV as mentioned below:

  • Nab-paclitaxel 100 mg/m^2 or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle.
Drug: Magrolimab
Administered intravenously
Other Names:
  • GS-4721
Drug: Paclitaxel
Administered intravenously
Other Names:
  • Taxol®
Drug: Nab-Paclitaxel
Administered intravenously
Other Names:
  • Abraxane
Experimental: Safety Run-in Cohort 2: Magrolimab + Sacituzumab govitecan

Participants will receive magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:

  • Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle;
  • Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle.
Drug: Magrolimab
Administered intravenously
Other Names:
  • GS-4721
Drug: Sacituzumab Govitecan-hziy
Administered intravenously
Other Names:
  • GS-0132
  • Trodelvy®
Experimental: Phase 2 Cohort 2: Magrolimab + Sacituzumab govitecan

Participants will receive magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:

  • Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle;
  • Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle.
Drug: Magrolimab
Administered intravenously
Other Names:
  • GS-4721
Drug: Sacituzumab Govitecan-hziy
Administered intravenously
Other Names:
  • GS-0132
  • Trodelvy®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time Frame: First dose date up to 28 days (Cohort 1) and up to 21 days (Cohort 2)

A DLT is defined as any:

  • Grade 3 or higher hematologic toxicity including:

    • Hemolytic anemia that is medically significant, requiring hospitalization or prolongation of existing hospitalization, disabling, or limiting self-care activities of daily life.

  • Event meeting Hy's Law criteria:

    • Treatment-emergent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (at least 3 x ULN), AND
    • Treatment-emergent total bilirubin elevation (more than 2 x ULN), and absence of cholestasis (defined as alkaline phosphatase less than 2 x 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).
  • 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.
First dose date up to 28 days (Cohort 1) and up to 21 days (Cohort 2)
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: First dose date up to last dose date (up to 73 weeks) plus 30 days
TEAEs are defined as any events not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. TEAEs were 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. 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.
First dose date up to last dose date (up to 73 weeks) plus 30 days
Phase 2 Cohort 1: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time Frame: Up to 107 weeks

PFS was defined as the time from the date of randomization until the earliest date of documented disease progression (PD), as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Kaplan-Meier (KM) estimates were used in outcome measure analysis.
Up to 107 weeks
Safety Run-in Cohort 2 and Phase 2 Cohort 2: Confirmed Objective Response Rate (ORR) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time Frame: Up to 107 weeks

ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as determined at least 4 weeks after initial documentation of response by investigator assessment per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.
Up to 107 weeks
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0
Time Frame: First dose date up to last dose date (up to 73 weeks) plus 30 days

Treatment-emergent laboratory abnormalities according to NCI CTCAE V5.0 are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day before initiation of subsequent anti-cancer therapy. Grade 1 mild, Grade 2 moderate, Grade 3 severe, Grade 4 life-threatening and Grade 5 death.

Percentages were rounded off.
First dose date up to last dose date (up to 73 weeks) plus 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 2 Cohort 1: Confirmed ORR as Determined by Investigator Assessment Per RECIST, Version 1.1
Time Frame: Up to 107 weeks

ORR is defined as the percentage of participants who achieve a CR or PR that is confirmed at least 4 weeks after initial documentation of response, as measured by RECIST version 1.1, as determined by investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.
Up to 107 weeks
Safety Run-in Cohort 2 and Phase 2 Cohort 2: PFS as Determined by Investigator Assessment Using RECIST Version 1.1
Time Frame: Up to 107 weeks
PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Up to 107 weeks
Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Duration of Response (DOR) as Determined by Investigator Assessment Per RECIST Version 1.1
Time Frame: Up to 107 weeks
DOR is defined as time from first documentation of CR or PR to the earliest date of documented PD, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Up to 107 weeks
Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Overall Survival (OS)
Time Frame: Up to 107 weeks
OS is defined as time from date of randomization to death from any cause.
Up to 107 weeks
Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing TEAEs
Time Frame: First dose date up to last dose date (up to 73 weeks) plus 30 days

TEAEs are defined as any events not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. TEAEs were 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. 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.

Percentages were rounded-off.
First dose date up to last dose date (up to 73 weeks) plus 30 days
Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI CTCAE, Version 5.0
Time Frame: First dose date up to last dose date (up to 73 weeks) plus 30 days

Treatment-emergent laboratory abnormalities according to NCI CTCAE V5.0 are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day before initiation of subsequent anti-cancer therapy.

Percentages were rounded off.
First dose date up to last dose date (up to 73 weeks) plus 30 days
Percentage of Participants With Antidrug Antibodies (ADA) to Magrolimab
Time Frame: Up to 73 weeks
Up to 73 weeks
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time
Time Frame: Cohort 1: Predose - Day 1, 8, 22, 43, 85, 127, 190 and 253, Postdose 1 hour - Day 8 and 43; Cohort 2: Predose - Day 1, 8, 22, 43, 64, 85, 127, 190 and 253, Postdose 1 hour - Day 43 and 64
Cohort 1: Predose - Day 1, 8, 22, 43, 85, 127, 190 and 253, Postdose 1 hour - Day 8 and 43; Cohort 2: Predose - Day 1, 8, 22, 43, 64, 85, 127, 190 and 253, Postdose 1 hour - Day 43 and 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Actual)

October 8, 2024

Study Completion (Actual)

October 8, 2024

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Estimated)

November 4, 2025

Last Update Submitted That Met QC Criteria

October 30, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-586-6144
  • 2021-001074-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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