Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
Stopped early · Phase 2
Conditions studied: Triple-Negative Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT04958785
- Run by
- Gilead Sciences
- People needed
- 92
- Starts
- 2021-12-14
- Expected to finish
- 2024-10-08
- Last updated by the study team
- 2025-11-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Mayo Clinic — Jacksonville, Florida, United States
- 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
- 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
- Cancer Research SA — Adelaide, South Australia, Australia
- Flinders Medical Centre — Bedford Park, South Australia, Australia
- Box Hill Hospital — Box Hill, Victoria, Australia
Full record on ClinicalTrials.gov
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