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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BGB-15025 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is being evaluated in a Phase 1 clinical trial in adult patients with advanced solid tumors, both as a single agent and in combination with the anti-PD-1 monoclonal antibody tislelizumab.
BGB-15025 targets HPK1, also known as hematopoietic progenitor kinase 1, which is a kinase enzyme. By inhibiting HPK1, the drug is designed to modulate immune signaling pathways in the tumor microenvironment. This mechanism is being explored as a potential approach to enhance anti-tumor immune responses in patients with advanced solid tumors.
BGB-15025 is being developed by BeOne Medicines Ltd., which trades under the ticker symbol ONC. The company is sponsoring the clinical development of this investigational agent for advanced solid tumors.
BGB-15025 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory agency. The ongoing Phase 1 trial is evaluating its safety, tolerability, and preliminary activity in patients with advanced solid tumors.
BGB-15025 is being studied in one active clinical trial, NCT04649385, titled "BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors." This Phase 1 trial has an enrollment of 157 participants and is currently active but not recruiting. It is being conducted in the United States, Australia, China, New Zealand, and South Korea.