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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Advanced Solid Tumor
• Advanced Breast Cancer
• Metastatic Breast Cancer
• Hormone-receptor-positive Breast Cancer
• Hormone Receptor Positive Breast Carcinoma
• Hormone Receptor Positive Malignant Neoplasm of Breast
• HER2-negative Breast Cancer
• Hormone Receptor Positive HER-2 Negative Breast Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

BeOne Medicines

Last updated on ClinicalTrials.gov

October 15, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites