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.

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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.