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Trials / Recruiting

RecruitingNCT06257264

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

A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
258 (estimated)
Sponsor
BeiGene · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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).

Conditions

Interventions

TypeNameDescription
DRUGBG-68501Planned doses administered orally.
DRUGFulvestrantStandard dose administered via intramuscular injection.
DRUGBGB-43395Planned doses administered orally.

Timeline

Start date
2024-03-11
Primary completion
2028-04-01
Completion
2028-07-01
First posted
2024-02-13
Last updated
2026-03-05

Locations

24 sites across 6 countries: United States, Australia, China, Israel, Moldova, New Zealand

Regulatory

Source: ClinicalTrials.gov record NCT06257264. Inclusion in this directory is not an endorsement.