Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-15025 · 1 trial · 1 indication
Participants will be considered evaluable for DLTs if they 1) received ≥ 80% of each scheduled study treatment administration during the DLT assessment window and/or 2) experienced a DLT.
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Dose Escalation | EXPERIMENTAL | Part A: Participants will receive once daily of BGB-15025 monotherapy in sequential cohorts of approximately 7 increasing doses Part B: Participants will receive once daily of BGB-15025 in sequential cohorts plus 200mg tislelizumab on day 1 of each 21-day cycle (combination therapy ) |
| Phase 1b: Dose Expansion | EXPERIMENTAL | Phase 1b dose expansion will begin based upon the recommended doses for expansion (RDFE) for BGB-15025 alone or in combination with tislelizumab, and with or without chemotherapy as determined from Phase 1a |
| Name | Type | Description |
|---|---|---|
| BGB-15025 | DRUG | Administered orally once or twice daily (QD or BID) |
| Tislelizumab | DRUG | Administered 200 mg intravenous (IV) infusion |
Key Inclusion Criteria: 1. Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused, and who hav...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BGB-15025 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied as a monotherapy and in combination with another investigational agent in patients with advanced solid tumors.
BGB-15025 targets HPK1, a kinase enzyme involved in immune cell signaling. By inhibiting HPK1, the drug is designed to modulate immune responses, potentially enhancing the body's ability to fight cancer. This mechanism is being explored in the context of advanced solid tumors.
BGB-15025 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 advanced solid tumors.
BGB-15025 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. The ongoing Phase 1 trial is evaluating the drug alone and in combination with another therapy in patients with advanced solid tumors.
BGB-15025 is being studied in a Phase 1 clinical trial with the identifier NCT04649385. This trial, titled "BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors," is active but not recruiting participants. The study is enrolling 157 patients across the United States, Australia, China, New Zealand, and South Korea.
No, BGB-15025 is not the same as tislelizumab. BGB-15025 is a small molecule that targets HPK1, while tislelizumab is an anti-PD-1 monoclonal antibody. In the ongoing clinical trial, BGB-15025 is being studied both alone and in combination with tislelizumab to evaluate their effects in patients with advanced solid tumors.