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Also known as Investigational product, DS-6051a (a free base of 6051b)
DS6051b · 1 trial · 1 indication
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 | 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 |
DS6051b is an investigational small molecule being developed by Nuvation Bio Inc. for the treatment of solid tumors. It is a biomarker-selected oncology candidate that has been studied in a single Phase 1 first-in-human clinical trial. DS6051b has not been approved by the FDA and remains in clinical development.
DS6051b is being studied for use in patients with solid tumors. The clinical program enrolled adults aged 18 years and older with solid tumor diagnoses, and the study was biomarker-selected, meaning enrollment was guided by a specific biomarker. DS6051b is investigational and is not approved for any indication.
DS6051b is being developed by Nuvation Bio Inc., which trades on the New York Stock Exchange under the ticker NUVB. The company is the sponsor of the clinical program evaluating DS6051b in solid tumors.
DS6051b is in Phase 1 development. Its only recorded clinical trial was a first-in-human Phase 1 study evaluating safety, tolerability and pharmacokinetics in solid tumors, and that trial is now completed. DS6051b is investigational and has not been approved by the FDA.
DS6051b has been evaluated in one clinical trial, NCT02279433, titled a first-in-human study to evaluate the safety, tolerability and pharmacokinetics of DS-6051b. That Phase 1 trial enrolled 46 participants with solid tumors in the United States and is completed. No active trials of DS6051b are currently listed.
The Phase 1 trial of DS6051b, NCT02279433, enrolled 46 participants. It was an uncontrolled, non-randomized, open-label first-in-human study conducted in the United States in adults aged 18 years and older with solid tumors. The trial evaluated safety, tolerability and pharmacokinetics and is completed.