Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-43395 · 3 trials · 11 indications
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Number of participants with AEs and SAEs including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments as needed, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
RDFE of BGB-43395 alone or as part of combination therapies will be determined based upon the MTD or MAD.
ORR is defined as the percentage of participants who have 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 |
|---|---|---|
| Arm A: BGB-43395 + Letrozole | EXPERIMENTAL | Participants will receive BGB-43395 in combination with letrozole. |
| Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole | ACTIVE_COMPARATOR | Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole. |
| Phase 1a: Dose Escalation | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BGB-43395 will be evaluated as monotherapy and in combination with either fulvestrant or letrozole. |
| Phase 1b: Dose Expansion | EXPERIMENTAL | The recommended dose for expansion (RDFE) for BGB-43395 in combination with fulvestrant from Phase 1a will be evaluated in HR+ breast cancer and selected tumor cohorts. |
| Dose Escalation | EXPERIMENTAL | Phase 1a: Sequential cohorts of increasing dose levels of BGB-43395 will be evaluated as monotherapy and in combination with either fulvestrant, letrozole, or elacestrant to assess for safety and tolerability. |
| Safety Expansion | EXPERIMENTAL | Phase 1a: Cohorts of selected dose levels of BGB-43395 in combination with fulvestrant or letrozole in HR+/HER2 breast cancer. |
| Dose Expansion Cohort 1 | EXPERIMENTAL | Phase 1b: The recommended dose for expansion (RFDE) for BGB-43395 (in combination with fulvestrant) from Phase 1a will be evaluated in HR+ breast cancer. |
| Dose Expansion Cohort 2 | EXPERIMENTAL | Phase 1b: The recommended dose for expansion (RFDE) for BGB-43395 in combination with letrozole from Phase 1a will be evaluated in HR+ breast cancer. |
| Dose Expansion Cohort 3 | EXPERIMENTAL | Phase 1b: The recommended dose for expansion (RFDE) for BGB-43395 in combination with letrozole from Phase 1a will be evaluated in HR+ breast cancer. Participants will also receive an anti-diarrheal agent for prophylaxis. |
| Name | Type | Description |
|---|---|---|
| BGB-43395 | DRUG | Administered orally. |
| Letrozole | DRUG | Administered orally. |
| Abemaciclib | DRUG | Administered orally. |
| Palbociclib | DRUG | Administered orally. |
| Ribociclib | DRUG | Administered orally. |
| Fulvestrant | DRUG | Administered via intramuscular injection. |
| Elacestrant | DRUG | Standard dose administered orally as a tablet. |
| Anti-Diarrheal Agent | DRUG | Administered orally as a tablet. |
Inclusion Criteria: * Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent. * Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer. * ...
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BGB-43395 is an investigational small molecule drug being developed by BeOne Medicines Ltd. for advanced solid tumors and HR+/HER2- breast cancer. It is a CDK4-targeted therapy currently in clinical development, including a Phase 3 trial in HR+/HER2- breast cancer and Phase 1 studies in advanced solid tumors.
BGB-43395 is being studied for HR+/HER2- breast cancer, including advanced or metastatic disease. A Phase 3 trial is evaluating BGB-43395 plus letrozole versus CDK4/6 inhibitor plus letrozole in patients who have not received prior treatment for advanced or metastatic disease. It is also being studied in other advanced solid tumors.
BGB-43395 targets CDK4, a protein involved in cell cycle regulation. By inhibiting CDK4, the drug aims to interfere with cancer cell proliferation. This targeted approach is being evaluated in HR+/HER2- breast cancer and other advanced solid tumors.
BGB-43395 is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is running clinical trials for the drug in multiple countries, including the United States, China, Australia, and several European and Asian nations.
BGB-43395 is in Phase 3 clinical development. A Phase 3 trial (NCT07492641) is currently recruiting participants with HR+/HER2- breast cancer. Additionally, Phase 1 trials have been conducted, with one completed (NCT06253195) and one ongoing (NCT06120283). The drug is investigational and has not been approved by the FDA.
BGB-43395 is being evaluated in three registered clinical trials. The Phase 3 trial NCT07492641 is recruiting patients with HR+/HER2- breast cancer. The Phase 1 trial NCT06120283 is recruiting patients with breast cancer and other advanced solid tumors. Another Phase 1 trial, NCT06253195, has been completed in Chinese participants.