drugset / Trial / NCT06120283

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

NCT06120283 ↗

Phase 1 Recruiting 433 enrolled BeOne Medicines
Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2023-12-01
Primary completion
2029-12
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Subject BGB-43395 Unknown — Oral
Subject Elacestrant Other / unclassified — Oral
Subject Fulvestrant Small molecule — Intramuscular
Subject Letrozole Other / unclassified — Oral