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DS-6000a

Phase 1

Renal Cell Carcinoma | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jul 28, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment179

FDA Designations

No designations recorded

Clinical trial landscape

DS-6000a · 1 trial · 2 indications

Phase 1 1
NCT04707248A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian TumorsRenal Cell Carcinoma
ACTIVE NOT_RECRUITING179 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
Renal Cell Carcinoma
NCT04707248179
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Study Endpoints

Primary Endpoints

Number of Participants With Dose-limiting toxicities (DLTs)
Day 1 to Day 21 in Cycle 1 (each cycle is 21 days)
Number of Participants Reporting Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
From start of treatment up to 40 days after last dose, up to approximately 52 months
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Dose Expansion)
From start of treatment (Cycle 1, Day 1) up to disease progression, up to approximately 52 months (each cycle is 21 days)

ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR).

Secondary Endpoints

Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve from Time Zero to 21 Days (AUC 21d) for R-DXd and its Metabolites
Cycles 1 and 3, Day 1: Predose, 3 hours, 5 hours, 8 hours postdose, end of infusion (EOI); Cycles 1 and 3, Day 2; Cycles 1 and 3, Days 4, 8, and 15; Cycle 2, Day 1: predose and EOI; Cycle 4, Day 1 and every then 2 cycles: predose (each cycle is 21 days)
Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve Up to the Last Quantifiable Time (AUClast) for R-DXd and its Metabolites
Cycles 1 and 3, Day 1: Predose, 3 hours, 5 hours, 8 hours postdose, end of infusion (EOI); Cycles 1 and 3, Day 2; Cycles 1 and 3, Days 4, 8, and 15; Cycle 2, Day 1: predose and EOI; Cycle 4, Day 1 and every then 2 cycles: predose (each cycle is 21 days)
Pharmacokinetic Analysis Maximum Plasma Concentration (Cmax) for R-DXd and its Metabolites
Cycles 1 and 3, Day 1: Predose, 3 hours, 5 hours, 8 hours postdose, end of infusion (EOI); Cycles 1 and 3, Day 2; Cycles 1 and 3, Days 4, 8, and 15; Cycle 2, Day 1: predose and EOI; Cycle 4, Day 1 and then every 2 cycles: predose (each cycle is 21 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALParticipants with ovarian cancer (OVC) or renal cell carcinoma (RCC) will receive an intravenous infusion of R-DXd (starting dose 1.6 mg/kg).
Dose Expansion: Cohort B-1EXPERIMENTALParticipants with RCC will receive an intravenous infusion of R-DXd at the RDE. Enrollment has ended for this cohort.
Dose Expansion: Cohort B-2EXPERIMENTALParticipants with OVC will receive an intravenous infusion of R-DXd at the RDE.

Interventions

NameTypeDescription
DS-6000aDRUGIntravenous administration at doses starting at 1.6 mg/kg on Day 1 of Cycle 1
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Written informed consent * At least 18 years of age * Eastern Cooperative Oncology Group Performance Status score of 0 or 1 * Availability of archived tumor tissue samples * Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated a...

Countries:United StatesJapan
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Frequently asked questions about DS-6000a

What is DS-6000a used for?

DS-6000a is an investigational small molecule being studied for the treatment of advanced renal cell carcinoma and ovarian tumors. It is currently in Phase 1 clinical development, and it is not yet approved by regulatory authorities.

Who makes DS-6000a?

DS-6000a is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is DS-6000a in?

DS-6000a is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for any use. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 179 patients.

What clinical trials is DS-6000a in?

DS-6000a is being evaluated in a Phase 1 clinical trial with the identifier NCT04707248. The study is titled 'A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors' and is being conducted in the United States and Japan.

Is DS-6000a the same as any other drug?

DS-6000a is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information.