Summary

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

Description

Summary

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

Keywords

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

Eligibility

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.

Locations

  • 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT04958785
Phase
Phase 2 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 144 study participants
Last Updated