Clinical Trials

Inclusion Criteria:

• Individual has provided informed consent.
• Individual is willing and able to comply with clinic visits and procedures outlined in the study protocol.
• Male or female, ≥ 18 years of age.
• Individuals must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Laboratory measurements - blood counts:
  • Hemoglobin ≥ 9.5 g/dL. Red blood cell transfusions are permitted to meet the hemoglobin inclusion criteria, within limits set per exclusion criterion;
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 /mL;
  • Platelets ≥ 100 x 10^9 /mL.
• Laboratory measurements - renal function: 
  • Serum creatinine ≤ 1.5 x upper ULN or if elevated, a calculated glomerular filtration rate > 40 mL/min/1.73m².
• Adequate liver function, as demonstrated by:
  • AST ≤ 2.5 x ULN;
  • ALT ≤ 2.5 x ULN;
  • Bilirubin ≤ 1.25 x ULN; or
  • ≤ 3.0 x ULN and primarily unconjugated if patient has a documented history of Gilbert’s syndrome or genetic equivalent.
• Pretreatment blood cross-match completed.
• Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
• Measurable disease according to RECIST, version 1.1. Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.
• Patients must be willing to provide baseline tumor tissue from a core or excisional biopsy (fine needle aspirate is not adequate). A newly obtained biopsy (within 90 days prior to study treatment start) is strongly preferred, but an archival sample (within 6 months prior to study treatment start) is acceptable. Patients will also be requested to consent to a mandatory on-treatment tumor biopsy unless not feasible as determined by the investigator and discussed with the sponsor.
• Patients previously untreated for unresectable locally advanced or mTNBC that is histologically or cytologically confirmed based on the most recent analyzed biopsy or other pathology specimen, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guideline.
• Patients whose tumors do not express programmed cell death ligand 1 (PD-L1), as determined by an approved test according to local regulations.
• Prior systemic treatment for neoadjuvant and/or adjuvant therapy and/or curative intent radiation therapy is permitted if completed at least 6 months prior to enrollment.
  • Note: Maintenance therapies are not counted as separate lines of therapy.

Exclusion Criteria:

• Positive serum pregnancy test.
• Breastfeeding female.
• Active central nervous system (CNS) disease. Patients 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.
• Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. RBC 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.
• Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
• Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha-targeting agents.
• Current participation in another interventional clinical trial.
• Known inherited or acquired bleeding disorders.
• Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study.
• Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which patients are not on active anticancer therapies and who are in complete remission for over 2 years.
• Known active or chronic hepatitis B or C infection or human immunodeficiency virus infection in medical history).
• Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.
• Uncontrolled pleural effusion.
• Uncontrolled hypercalcemia (ionized calcium >1.5 mmol/L) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
• Uncontrolled tumor-related pain.
• Severe/serious systemic infection within 4 weeks of randomization.
  • NOTE: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormone releasing hormone (LHRH) agonists for prostate or breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappaB ligand (RANKL) inhibitors are not criteria for exclusion. There is no required minimum washout period for these therapies. Patients should be recovered from the effects of radiation.

Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.