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 expansion (RDFE) for BG-68501 as monotherapy and in combination for subsequent disease directed studies. The study will be conducted in 2 parts: Part 1 (dose escalation and safety expansion, including evaluation of food effect) and Part 2 (dose expansion).

NCT Number	NCT06257264
Lead Sponsor	BeiGene
Conditions	Breast Cancer, Small Cell Lung Cancer, Ovarian Cancer, Gastric Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced Solid Tumor, Endometrial Cancer +4 more
Enrollment	103 participants
Start Date	2024-03-11
Primary Completion	2026-08-31 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-18