Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in this study are: * Axatilimab (a type of antibody) * Olaparib (a type of PARP inhibitor)

Trial Details

NCT ID
NCT06488378
Phase
PHASE1
Sponsor
Dana-Farber Cancer Institute
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Axatilimab
  • Olaparib
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Participants must have histologically or cytologically confirmed metastatic or unresectable HER2 negative breast cancer, including HER2 low (IHC 2+…
  • Documented germline or somatic mutation in BRCA1, BRCA2, or germline mutation in PALB2 that is predicted to be deleterious or suspected deleterious…
  • Participants must have evaluable or measurable disease per RECIST 1.1 criteria. NOTE: If the only site of measurable of disease has been previously…
  • Patients must have received no more than 2 prior lines of cytotoxic chemotherapy for metastatic disease. Antibody drug conjugates will count toward…

For full eligibility, visit ClinicalTrials.gov.

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