Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04649385 | BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 157 | — | — | Mar 4, 2021 | May 16, 2026 | Feb 20, 2026 | 20 | United States, Australia +3 |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |