RecruitingPhase 1NCT07244341

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

A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Sponsor

Daiichi Sankyo

Enrollment

60 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

Summary

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

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — valemetostat (which targets cancer-supporting proteins) and darolutamide (a hormone-blocking drug) — in men with prostate cancer that has spread and stopped responding to standard hormone therapy (called metastatic castration-resistant prostate cancer). **You may be eligible if...** - You are a man aged 18 or older - You have prostate cancer that has spread and is no longer responding to standard hormone treatment - Your cancer has been confirmed by biopsy - You have received certain prior treatments for advanced prostate cancer **You may NOT be eligible if...** - You have received certain prior treatments that make you ineligible - You have significant heart, liver, or kidney problems - You have active brain metastases - You are unable to swallow pills Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGValemetostat

Dose Escalation Part: Valemetostat will be administered at escalating doses. Dose Expansion Part: Valemetostat will be administered at 2 or more dose levels.

DRUGDarolutamide

Dose Escalation Part: Darolutamide will be administered at a standard dose. Dose Expansion Part: Darolutamide will be administered at a standard dose.

Locations(19)

University of California San Diego Moores Cancer Center

La Jolla, California, United States

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Newton, Massachusetts, United States

Cancer & Hematology Center

Grand Rapids, Michigan, United States

Northwell Health Cancer Institute (START NY)

Lake Success, New York, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

NEXT Oncology

San Antonio, Texas, United States

Virginia Cancer Specialists (NEXT Virginia)

Fairfax, Virginia, United States

Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

Sun Yatsen University Cancer Center

Guangzhou, China

Fudan University Shanghai Cancer Center - Xuhui District

Shanghai, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shanghai General Hospital

Shanghai, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Mater Misericordiae University Hospital

Dublin, Ireland

National Cancer Center Hospital East

Kashiwa-shi, Japan

Kobe City Med Cen Gen Hosp.

Kobe, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

Toho University Sakura Medical Center

Sakura-shi, Japan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07244341

Related Trials

A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

NCT06629779240 locations

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

NCT07213674134 locations

Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer

NCT076410491 location

A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT0728715032 locations

Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

NCT072883599 locations