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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02279433 | A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b | PHASE1 | COMPLETED | 46 | — | — | Sep 1, 2014 | Mar 1, 2019 | Jun 24, 2025 | 6 | United States |
Tumor response will be assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
| Arm | Type | Description |
|---|---|---|
| DS-6051b | EXPERIMENTAL | DS-6051b is orally administered as 50 mg and 200 mg capsules once daily on Days 1 to 21 of a 21-day cycle. Dose escalation in Part 1 will continue until tentative Recommended Part 2 Dose (RP2D) is determined. In Part 2 participants will receive the RP2D. |
| Name | Type | Description |
|---|---|---|
| DS6051b | DRUG | DS-6051b 50 mg and 200 mg capsules for oral administration |
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of advanced solid tumors that have relapsed from or are refractory to standard treatment or for which no standard treatment is available 2. Part 1 Dose Escalation subjects must meet 1 of the following criteria: * Solid t...
| 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 |