BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.

Trial Details

NCT ID
NCT06120283
Phase
PHASE1
Sponsor
BeOne Medicines
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • BGB-43395
  • Fulvestrant
  • Letrozole
  • Elacestrant
Locations (sample)
  • Denver, Colorado, United States|39.73915,-104.9847
  • Lake Mary, Florida, United States|28.75888,-81.31784
  • Detroit, Michigan, United States|42.33143,-83.04575
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Durham, North Carolina, United States|35.99403,-78.89862

Key Eligibility Criteria

  • Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associat…
  • Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have …
  • Phase 1b: Participants with HR+/HER2- breast cancer.
  • Phase 1b: For combination with fulvestrant, participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and …

For full eligibility, visit ClinicalTrials.gov.

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