A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-68501 in participants with advanced, nonresectable, or metastatic solid tumors as monotherapy and in combination with fulvestrant with or without BGB-43395, a selective CDK4 inhibitor, in adults with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC). The study will also identify a recommended dose for expa

Trial Details

NCT ID
NCT06257264
Phase
PHASE1
Sponsor
BeiGene
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • BG-68501
  • Fulvestrant
  • BGB-43395
Locations (sample)
  • Newport Beach, California, United States|33.61891,-117.92895
  • Lake Mary, Florida, United States|28.75888,-81.31784
  • St Louis, Missouri, United States|38.62727,-90.19789
  • East Brunswick, New Jersey, United States|40.42788,-74.41598
  • Sioux Falls, South Dakota, United States|43.54369,-96.72796

Key Eligibility Criteria

  • Monotherapy Cohorts: Participants with histologically or cytologically confirmed advanced or metastatic solid tumors potentially associated with CD…
  • Combination Cohorts (BG-68501 with fulvestrant with or without BGB-43395): Enrollment is restricted to only participants with HR+/HER2- BC. In regi…
  • Part 1 (Safety Expansion) and Part 2 (Dose Expansion) Inclusion Criteria:
  • Participants with advanced, non-resectable, or metastatic HR+/HER2- BC or PROC, including fallopian tube or primary peritoneal cancer.

For full eligibility, visit ClinicalTrials.gov.

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