Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
NCT ID: NCT04958785
Last Updated: 2025-11-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
92 participants
INTERVENTIONAL
2021-12-14
2024-10-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Magrolimab
Administered intravenously
Nab-Paclitaxel
Administered intravenously
Paclitaxel
Administered intravenously
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.
Magrolimab
Administered intravenously
Nab-Paclitaxel
Administered intravenously
Paclitaxel
Administered intravenously
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.
Magrolimab
Administered intravenously
Nab-Paclitaxel
Administered intravenously
Paclitaxel
Administered intravenously
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.
Magrolimab
Administered intravenously
Sacituzumab Govitecan-hziy
Administered intravenously
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.
Magrolimab
Administered intravenously
Sacituzumab Govitecan-hziy
Administered intravenously
Interventions
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Magrolimab
Administered intravenously
Nab-Paclitaxel
Administered intravenously
Paclitaxel
Administered intravenously
Sacituzumab Govitecan-hziy
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University Cancer & Blood Center,LLC
Athens, Georgia, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, United States
Southeastern Regional Medical Center, LLC
Newnan, Georgia, United States
Orchard Healthcare Research Inc
Skokie, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Allina Health Cancer Institute
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Mayo Clinic
Phoenix, Arizona, United States
Women's Cancer Care
Fresno, California, United States
Providence Medical Foundation
Fullerton, California, United States
University of California San Francisco
San Francisco, California, United States
Saint John's Cancer Institute
Santa Monica, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
Cancer Research SA
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Peninsula Health
Frankston, Victoria, Australia
Barwon Health- University Hospital Geelong
Geelong, Victoria, Australia
Ballarat Oncology & Haematology Services
Wendouree, Victoria, Australia
Queen Mary Hospital
Hong Kong, , Hong Kong
Princess Margaret Hospital
Kowloon, , Hong Kong
Prince of Wales Hospital
New Territories, , Hong Kong
Samsung Medical Center
Gangnam-Gu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Seoul National University Hospital
Jongrogu, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Taipei Veterans General Hospital
Beitou District, , Taiwan
Changhua Christian Hospital
Changhua, , Taiwan
Chang Gung Memorial Hospital, Linkou
Guishan District, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Sanmin District, , Taiwan
National Taiwan University Hospital
Tapiei, , Taiwan
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
University College London
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Mayo Clinic
Jacksonville, Florida, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
NYU Investigational Pharmacy, Laura & Isaac Perlmutter Cancer Center
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Charleston Oncology
Charleston, South Carolina, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Cairns and Hinterland Hospital and Health Service
Cairns, Queensland, Australia
University of the Sunshine Coast
Sippy Downs, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2021-001074-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-586-6144
Identifier Type: -
Identifier Source: org_study_id
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