Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-43395 · 4 trials · 12 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. |
| Part 1: Relative Bioavailability | EXPERIMENTAL | Participants will receive a single dose of each formulation of BGB-43395 in separate periods across various sequences. |
| Part 2: Food Effect | EXPERIMENTAL | Participants will receive three doses of the selected formulation of BGB-43395 under fasted, low-fat, or high-fat conditions in separate periods across various sequences. |
| 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 being studied for the treatment of advanced solid tumors, including HR+/HER2- breast cancer. It is also being evaluated in healthy volunteers to assess different formulations and food effects. The drug is in clinical development and is not yet approved by regulatory authorities.
BGB-43395 targets CDK4, a protein involved in cell cycle regulation. By inhibiting CDK4, the drug aims to interfere with cancer cell proliferation. This mechanism is being explored in clinical trials for advanced solid tumors and HR+/HER2- breast cancer.
BGB-43395 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed under the ticker symbol ONC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.
BGB-43395 is in Phase 1 clinical development. The drug is being studied in early-stage trials for advanced solid tumors and HR+/HER2- breast cancer, as well as in healthy volunteers. It is investigational and has not received regulatory approval.
BGB-43395 is being evaluated in several clinical trials. NCT06120283 is a Phase 1 study in advanced solid tumors and breast cancer. NCT06253195 is a completed Phase 1 study in Chinese participants. NCT06761898 is a completed healthy volunteer study. NCT07492641 is a Phase 3 trial comparing BGB-43395 plus letrozole to other CDK4/6 inhibitors.
BGB-43395 is a CDK4 inhibitor, but it is a distinct investigational drug developed by BeOne Medicines Ltd. It is being compared to other CDK4/6 inhibitors in a Phase 3 clinical trial for HR+/HER2- breast cancer, but it is not the same as those approved agents.