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DS6051b

Phase 1

Solid Tumors | Small molecule | Oncology |Nuvation Bio Inc.|Last Updated: Jun 24, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

DS6051b · 1 trial · 1 indication

Phase 1 1
NCT02279433A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051bSolid Tumors
COMPLETED46 Analytics
PHASE1COMPLETED
A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Number of participants with dose-limiting toxicities
within 21 days following the first dose of treatment
Tumor response
up to 2 years

Tumor response will be assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

Secondary Endpoints

Maximum concentration (Cmax) for DS-6051a
At Days 1 and 15 of Cycle 1 (21 days)
Time to maximum concentration (Tmax) for DS-6051a
At Days 1 and 15 of Cycle 1 (21 days)
Area under the concentration-time curve from time zero to t (AUC0-t) for DS-6051a
At Days 1 and 15 of Cycle 1 (21 days)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DS-6051bEXPERIMENTALDS-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.

Interventions

NameTypeDescription
DS6051bDRUGDS-6051b 50 mg and 200 mg capsules for oral administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about DS6051b

What is DS6051b used for?

DS6051b is an investigational small molecule being studied for the treatment of solid tumors. It is currently in Phase 1 clinical development, with a completed first-in-human trial evaluating its safety, tolerability, and pharmacokinetics in patients with solid tumors.

Who makes DS6051b?

DS6051b is being developed by Nuvation Bio Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol NUVB.

What phase is DS6051b in?

DS6051b is in Phase 1 clinical development. A first-in-human study has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities and is still undergoing clinical evaluation.

What clinical trials is DS6051b in?

DS6051b has one completed clinical trial, identified as NCT02279433. This was a first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in patients with solid tumors. The trial enrolled 46 participants in the United States.

Is DS6051b FDA approved?

DS6051b is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on safety and tolerability, and the drug has not yet received regulatory approval for any indication.