Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-21447 · 1 trial · 3 indications
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and AEs that meet protocol-defined dose-limiting toxicity criteria.
RDFE of BGB-21447 in combination with fulvestrant and in combination with fulvestrant and BGB-43395 will be determined based upon the maximum tolerated dose (MTD) or maximum administered dose (MAD).
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1A: BGB-21447 + Fulvestrant | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant. |
| Part 1B: BGB-21447 + BGB-43395 + Fulvestrant | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant and BGB-43395. |
| BGB-21447 + Fulvestrant Food Effect Substudy | EXPERIMENTAL | Participants will receive BGB-21447 at the recommended dose with a high-fat meal and under a fasted state in combination with fulvestrant. |
| Part 2: Dose Expansion, BGB-21447 + Fulvestrant | EXPERIMENTAL | Participants will receive BGB-21447 at the recommended dose(s) for expansion determined in Part 1A in combination with fulvestrant. |
| Name | Type | Description |
|---|---|---|
| BGB-21447 | DRUG | Administered orally. |
| Fulvestrant | DRUG | Administered via intramuscular injection. |
| BGB-43395 | DRUG | Administered orally. |
Inclusion Criteria: * Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer. Part 1A and 1B: Participants must have received ≥ 1 prior line(s) of treatment for advanced/metastatic disease, including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanc...
BGB-21447 is an investigational small molecule Bcl-2 inhibitor being developed by BeOne Medicines Ltd. for hormone-receptor-positive breast cancer. It is in Phase 1 clinical development and is being studied in combination regimens for adults with HR-positive, HER2-negative metastatic breast cancer.
BGB-21447 is being studied for hormone-receptor-positive, HER2-negative metastatic breast cancer. The Phase 1 trial enrolls adults with HR-positive and HER2-negative metastatic disease, and the study is biomarker selected. It is investigational and has not been approved for any use.
BGB-21447 targets Bcl-2, a protein that helps cancer cells avoid apoptosis. By inhibiting Bcl-2, the drug is designed to restore the cell death process in tumor cells. It is described as a Bcl-2 inhibitor and is being tested in combination with other agents.
BGB-21447 is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is running the Phase 1 program for the compound in hormone-receptor-positive, HER2-negative metastatic breast cancer.
BGB-21447 is in Phase 1 clinical development. It is investigational and is not approved by the FDA. The single Phase 1 trial is currently recruiting participants and has an planned enrollment of 120 patients.
BGB-21447 is being studied in the Phase 1 trial NCT06756932, titled BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer. The trial is recruiting, controlled, and enrolling 120 participants across the United States, Australia, and China.