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

This is an interventional treatment trial for Triple-Negative Breast Cancer Read More

Key Inclusion criteria:

• 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

Key Exclusion Criteria:

• 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.