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A Study of Valemetostat with Darolutamide for Metastatic Castration-Resistant Prostate Cancer

This study is testing a combination of two drugs, valemetostat and darolutamide, for men with metastatic castration-resistant prostate cancer (mCRPC). This is a type of prostate cancer that has spread to other parts of the body and is no longer responding to hormone therapy. The main goal is to see how safe the combination is and what side effects you might experience. Researchers will be looking at how many participants have dose-limiting toxicities (side effects that are severe enough to limit the dose) and other treatment-related side effects. To join, you must be an adult male, 18 years or older, with confirmed adenocarcinoma of the prostate. The study plans to enroll 60 participants.

Study design
This interventional study is testing different doses of valemetostat in combination with a standard dose of darolutamide. It plans to enroll 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects) from screening up to approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07244341

A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Daiichi Sankyo
~60 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:ValemetostatDarolutamide

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of participants with Dose-Limiting Toxicities (DLTs)
Measured over Day 1 up to Day 28
+1 more outcome measured

Conditions

Metastatic Castration-resistant Prostate Cancer

Explore related trials

Prostate CarcinomaKLK3 Gene

Where it's being run

19 sites across 11 states
China5
Japan4
Massachusetts2
California1
Michigan1
New York1
South Carolina1
Texas1

Who to contact

Contact for Trial Information
[email protected]
908-992-6400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Must not freeze or donate sperm starting at screening and throughout the Treatment Period, and for at least 3 months after the final trial intervention administration.
True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the participant, OR
Uses a penile/external condom when having penile-vaginal intercourse with an NPOCBP, PLUS partner use of an additional contraceptive method, as a condom may break or leak Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. If the contraception requirements in the local label for any trial interventions are more stringent than those above, the local label requirements are to be followed.

What this trial measures

  • Part 1: Number of participants with Dose-Limiting Toxicities (DLTs)Day 1 up to Day 28

    A DLT is defined as any Treatment Emergent Adverse Event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc, that occurs during the DLT evaluation period (Day 1 to Day 28) and is Grade ≥3.

  • Part 1 and 2: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)From Screening up to approximately 5 years

    TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 30 days after the last dose date of trial intervention).