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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-11-10
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.
Conditions
- Hormone-receptor-positive Breast Cancer
- HER2-negative Breast Cancer
- Metastatic Breast Cancer
Interventions
- DRUG
-
BGB-21447
Administered orally.
- DRUG
-
Administered via intramuscular injection.
- DRUG
-
BGB-43395
Administered orally.
Sponsors & Collaborators
-
BeOne Medicines
lead INDUSTRY
Principal Investigators
-
Study Director · BeOne Medicines
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-04
- Primary Completion
- 2027-07-30
- Completion
- 2027-07-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- China
Study Locations
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