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NCT07244341 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Daiichi Sankyo.

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
6
Study locations

NCT07244341: Recruiting Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Daiichi Sankyo.

NCT07244341 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 60 participants, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (70% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07244341, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Daiichi Sankyo.

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
6
Study locations

Study Summary

This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).

Primary Outcome

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.

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer

Interventions

  • DRUG Darolutamide
  • DRUG Valemetostat

Study Locations (6)

Other

  • Kobe City Med Cen Gen Hosp. - Kobe
  • Cancer Institute Hospital of JFCR - Kōtoku
  • Toho University Sakura Medical Center - Sakura-shi

South Carolina

  • Carolina Urologic Research Center - Myrtle Beach

Texas

  • NEXT Oncology - San Antonio

Virginia

  • Virginia Cancer Specialists (NEXT Virginia) - Fairfax

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-12-03
Est. Completion 2029-11-30
Phase Phase 1
Daiichi Sankyo

236 total trials

What NCT07244341 shows while recruiting

NCT07244341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (70% lower).

The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Darolutamide is the first listed.

NCT07244341 lists 6 locations in 4 states (Other, South Carolina, Texas).

Frequently Asked Questions

What is clinical trial NCT07244341 about?

NCT07244341 is a clinical study titled "A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)". This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).

What is the current status of trial NCT07244341?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2025-12-03. Estimated completion is 2029-11-30.

What conditions does trial NCT07244341 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.

What interventions are being tested in trial NCT07244341?

The interventions under investigation include: Darolutamide (DRUG), Valemetostat (DRUG).

Who is sponsoring clinical trial NCT07244341?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07244341 being conducted?

This trial has 6 study locations across South Carolina, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Castration-Resistant Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07244341's enrollment target sits among peer trials

60 38th of 69 higher than 30 of 69 other Metastatic Castration-Resistant Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07244341

Source: ClinicalTrials.gov NCT07244341, the US trial registry maintained by the National Library of Medicine. NCT07244341 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.