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Triple-Negative Breast CancerPhase 2ELEVATE TNBCNCT04958785

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

A Phase 2 study testing Magrolimab, Nab-Paclitaxel and Paclitaxel in people with Triple-Negative Breast Cancer, run by Gilead Sciences at 45 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple-Negative Breast Cancer
What is being tested?
Magrolimab, Nab-Paclitaxel and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
45 sitesin 6 countries
Study dates
14 Dec 2021to 8 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

45 sites in 6 countries.

45 sites in 6 countries

United States19 sites

  • University Cancer & Blood Center,LLC

    Athens, Georgia, 30607

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

  • Charleston Oncology

    Charleston, South Carolina, 29414

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Women's Cancer Care

    Fresno, California, 93710

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Allina Health Cancer Institute

    Minneapolis, Minnesota, 55407

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYU Investigational Pharmacy, Laura & Isaac Perlmutter Cancer Center

    New York, New York, 10016

  • Southeastern Regional Medical Center, LLC

    Newnan, Georgia, 30265

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

  • University of California San Francisco

    San Francisco, California, 94115

  • Saint John's Cancer Institute

    Santa Monica, California, 90404

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • Orchard Healthcare Research Inc

    Skokie, Illinois, 60077

  • Stony Brook University

    Stony Brook, New York, 11794

Other trials in United States

Australia10 sites

  • Cancer Research SA

    Adelaide, South Australia, 5000

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Cairns and Hinterland Hospital and Health Service

    Cairns, Queensland, 4870

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Peninsula Health

    Frankston, Victoria, 3199

  • Barwon Health- University Hospital Geelong

    Geelong, Victoria, '03220

  • University of the Sunshine Coast

    Sippy Downs, Queensland, 4556

  • Ballarat Oncology & Haematology Services

    Wendouree, Victoria, 3355

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

South Korea5 sites

  • Samsung Medical Center

    Gangnam-Gu, 06351

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Hospital

    Jongrogu, 110-744

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 5505

Other trials in South Korea

Taiwan5 sites

  • Taipei Veterans General Hospital

    Beitou District, 11257

  • Changhua Christian Hospital

    Changhua, 50006

  • Chang Gung Memorial Hospital, Linkou

    Guishan District, 131

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Sanmin District, 80778

  • National Taiwan University Hospital

    Tapiei

Other trials in Taiwan

Hong Kong3 sites

  • Queen Mary Hospital

    Hong Kong

  • Princess Margaret Hospital

    Kowloon

  • Prince of Wales Hospital

    New Territories

Other trials in Hong Kong

United Kingdom3 sites

  • University Hospitals of Leicester NHS Trust

    Leicester, LE1 5WW

  • University College London

    London, WC1E 6BT

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: 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).

Read more

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.

Being tested
Magrolimab, Nab-Paclitaxel, Paclitaxel, Sacituzumab Govitecan-hziy
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MagrolimabDrug

    Also called GS-4721

    Administered intravenously

  • Nab-PaclitaxelDrug

    Also called Abraxane

    Administered intravenously

  • PaclitaxelDrug

    Also called Taxol®

    Administered intravenously

  • Sacituzumab Govitecan-hziyDrug

    Also called GS-0132, Trodelvy®

    Administered intravenously

Study groups in NCT04958785
Study groupRoleWhat they receive
Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel or PaclitaxelExperimentalParticipants 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.
Receives: Drug: Magrolimab; Drug: Nab-Paclitaxel; Drug: Paclitaxel
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or PaclitaxelExperimentalParticipants 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.
Receives: Drug: Magrolimab; Drug: Nab-Paclitaxel; Drug: Paclitaxel
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or PaclitaxelActive comparatorParticipants 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.
Receives: Drug: Magrolimab; Drug: Nab-Paclitaxel; Drug: Paclitaxel
Safety Run-in Cohort 2: Magrolimab + Sacituzumab govitecanExperimentalParticipants 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.
Receives: Drug: Magrolimab; Drug: Sacituzumab Govitecan-hziy
Phase 2 Cohort 2: Magrolimab + Sacituzumab govitecanExperimentalParticipants 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.
Receives: Drug: Magrolimab; Drug: Sacituzumab Govitecan-hziy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)

    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.

    Measured: First dose date up to 28 days (Cohort 1) and up to 21 days (Cohort 2)

  2. Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    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.

    Measured: First dose date up to last dose date (up to 73 weeks) plus 30 days

  3. 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

    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.

    Measured: First dose date up to last dose date (up to 73 weeks) plus 30 days

  4. Phase 2 Cohort 1: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    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.

    Measured: Up to 107 weeks

  5. 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

    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.

    Measured: Up to 107 weeks

Secondary outcomes (8)

  1. Phase 2 Cohort 1: Confirmed ORR as Determined by Investigator Assessment Per RECIST, Version 1.1

    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.

    Measured: Up to 107 weeks

  2. Safety Run-in Cohort 2 and Phase 2 Cohort 2: PFS as Determined by Investigator Assessment Using RECIST Version 1.1

    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.

    Measured: Up to 107 weeks

  3. 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

    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.

    Measured: Up to 107 weeks

  4. Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Overall Survival (OS)

    OS is defined as time from date of randomization to death from any cause.

    Measured: Up to 107 weeks

  5. Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing TEAEs

    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.

    Measured: First dose date up to last dose date (up to 73 weeks) plus 30 days

  6. Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI CTCAE, Version 5.0

    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.

    Measured: First dose date up to last dose date (up to 73 weeks) plus 30 days

  7. Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time

    Measured: 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

  8. Percentage of Participants With Antidrug Antibodies (ADA) to Magrolimab

    Measured: Up to 73 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2021
  2. Study start14 Dec 2021
  3. Primary completion8 Oct 2024
  4. Study completion8 Oct 2024

Why it stopped: Sponsor decision to terminate study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04958785
Sponsor's protocol ID
GS-US-586-6144
Other IDs
2021-001074-27
Acronym
ELEVATE TNBC
Status last verified
Oct 2025
First submitted
1 Jul 2021
Last updated
4 Nov 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Magrolimab, Nab-Paclitaxel and Paclitaxel in people with Triple-Negative Breast Cancer, run by Gilead Sciences at 45 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Australia, South Korea, Taiwan, Hong Kong and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04958785.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.

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