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 being developed for hormone-receptor-positive breast cancer, specifically for adults with hormone-receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BGB-21447 is a Bcl-2 inhibitor, as indicated by its clinical trial title. It is designed to target the Bcl-2 protein, which plays a role in regulating cell survival and apoptosis. The drug is being studied in combination with other agents for the treatment of HR+/HER2- metastatic breast cancer.
BGB-21447 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ONC. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with hormone-receptor-positive breast cancer.
BGB-21447 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in the target patient population.
BGB-21447 is being studied in a Phase 1 clinical trial registered as NCT06756932. This trial, 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,' is currently recruiting participants in the United States, Australia, and China, with a planned enrollment of 120 patients.