drugset / Trial / NCT06756932

BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer

NCT06756932

Phase 1 Recruiting 120 enrolled BeOne Medicines
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+/HER2- metastatic breast cancer.

Timeline

Start
2025-02-04
Primary completion
2027-07-30
Completion
2027-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject BGB-21447 Unknown Oral
Subject BGB-43395 Unknown Oral
Background Fulvestrant Small molecule Intramuscular