for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion



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.

Official Title

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


Triple-Negative Breast Cancer, Breast Neoplasms, Triple Negative Breast Neoplasms, Paclitaxel, Albumin-Bound Paclitaxel, Magrolimab, Nab-Paclitaxel, Sacituzumab govitecan


You can join if…

Open to people ages 18 years and up

  • Adequate performance status, hematologic, renal and liver function
  • Measurable disease per RECIST v1.1
  • Cohort 1: Individuals with previously untreated unresectable locally advanced or metastatic TNBC that are considered PD-L1 negative (as determined by an approved test according to local regulations)
  • Cohort 2: Individuals with unresectable, locally advanced or metastatic TNBC who have received 1 prior line of therapy in the advanced setting (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 first-line treatment of locally advanced/metastatic TNBC

You CAN'T join if...

  • Positive serum pregnancy test or breastfeeding female
  • Active CNS disease. Individuals with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed
  • 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 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 or rapid visceral progression and/or symptomatic disease, where single-agent chemotherapy would not be appropriate.
  • 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 AEs due to a previously administered agent
      • Note: individuals with any grade neuropathy or alopecia 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.


  • University of California San Francisco accepting new patients
    San Francisco California 94115 United States
  • Women's Cancer Care accepting new patients
    Fresno California 93710 United States


accepting new patients
Start Date
Completion Date
Gilead Sciences
Gilead Clinical Trials Website
Phase 2 research study
Study Type
Expecting 144 study participants
Last Updated