BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer

This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+/HER2- metastatic breast cancer.

Trial Details

NCT ID
NCT06756932
Phase
PHASE1
Sponsor
BeOne Medicines
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • BGB-21447
  • Fulvestrant
  • BGB-43395
Locations (sample)
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Houston, Texas, United States|29.76328,-95.36327
  • Seattle, Washington, United States|47.60621,-122.33207
  • Darlinghurst, New South Wales, Australia|-33.87939,151.21925
  • Waratah, New South Wales, Australia|-32.90667,151.72647

Key Eligibility Criteria

  • Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer. Part 1A and 1B: Participants must have received ≥ 1 prior line(s) of …
  • Female participants will be required (either continue ongoing or initiate as soon as feasible) to have ovarian function suppression using gonadotro…
  • Male participants may be required to use GnRH agonists when being treated with fulvestrant at the discretion of the investigator.
  • Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.

For full eligibility, visit ClinicalTrials.gov.

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