Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-68501 · 1 trial · 12 indications
Number of participants with treatment-emergent AEs and SAEs.
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 BG-68501 alone will be determined based upon the MTD or MAD.
RDFE of BG-68501 in combination with fulvestrant and BGB-43395 will be determined based upon the MTD or MAD.
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). CR and PR that is confirmed by repeat assessments, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1 Part A: Dose Escalation and Safety Expansion (BG-68501 Monotherapy) | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-68501 will be evaluated as monotherapy. |
| Part 1 Part B: Dose Escalation (BG-68501 + Fulvestrant) | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-68501 will be evaluated in combination with fulvestrant. |
| Part 1 Part C: Dose Escalation and Safety Expansion (BG-68501 + Fulvestrant + BGB-43395) | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-68501 will be evaluated in combination with fulvestrant and BGB-43395. |
| Part 1: Food Effect Evaluation | EXPERIMENTAL | Participants will receive BG-68501 at a dose level that is determined safe and tolerable to evaluate food effect. Food effect may also be evaluated for BG-68501 in combination with fulvestrant. |
| Part 2: Dose Expansion | EXPERIMENTAL | The RFDE for BG-68501 (as monotherapy and in combination with fulvestrant and BGB-43395) from Part 1 will be evaluated in selected tumor cohorts. |
| Name | Type | Description |
|---|---|---|
| BG-68501 | DRUG | Planned doses administered orally. |
| Fulvestrant | DRUG | Standard dose administered via intramuscular injection. |
| BGB-43395 | DRUG | Planned doses administered orally. |
Part 1 (Dose Escalation) Inclusion Criteria: * Monotherapy Cohorts: Participants with histologically or cytologically confirmed advanced or metastatic solid tumors potentially associated with CDK2 dependency including HR+/HER2- breast cancer, platinum refractory or resistant serous ovarian cancer (...
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BG-68501 is an investigational small molecule being studied for the treatment of breast cancer, including hormone-receptor-positive, HER-2 negative breast cancer and triple-negative breast cancer. It is also being evaluated in other advanced solid tumors such as small cell lung cancer, ovarian cancer, gastric cancer, endometrial cancer, prostate cancer, gastroesophageal cancer, and bladder cancer.
BG-68501 targets CDK2, a protein involved in cell cycle regulation. By inhibiting CDK2, the drug is designed to interfere with cancer cell proliferation. It is being developed as a targeted therapy for biomarker-selected patients with advanced-stage tumors.
BG-68501 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ONC. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with advanced cancers.
BG-68501 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety, tolerability, and potential effectiveness in treating advanced-stage tumors.
BG-68501 is being studied in a Phase 1 clinical trial registered as NCT06257264. This trial is examining the safety of different doses of BG-68501 in participants with advanced-stage tumors. The study is currently recruiting and aims to enroll approximately 258 participants across multiple countries, including the United States, Australia, China, Israel, Moldova, and New Zealand.
BG-68501 is a specific investigational small molecule that targets CDK2. While it belongs to the class of CDK2 inhibitors, it is a distinct drug candidate developed by BeOne Medicines Ltd. No alternative names for BG-68501 have been reported in the clinical trial information.