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

Daiichi Sankyo
NCT IDNCT07244341ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1

Target enrollment

60

Study length

about 4 years

Ages

18+

Sex

Male only

Locations

3 sites in SC, TX, VA

What this study is about

Researchers are testing the safety and how well valemetostat works when taken with darolutamide for people with metastatic castration-resistant prostate cancer. The trial will last about 1458 days.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Darolutamide
  • 2.Take Valemetostat

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Oral

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

darolutamide

Drug routes

oral (Oral Tablet)

Endpoints

Primary: Part 1 and 2: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)

Secondary: Objective Response Rate (ORR), Overall Survival (OS), Prostate-Specific Antigen (PSA) 50 Response Rate, Prostate-Specific Antigen (PSA) 90 Response Rate, Prostate-Specific Antigen (PSA) Nadir Response Rate, Radiographic Progression-Free Survival (rPFS)

Body systems

Oncology