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

Part of paid clinical trials in La Jolla, California.

Sponsor
Daiichi Sankyo
Study ID
NCT07244341
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Valemetostat — DRUG
    Dose Escalation Part: Valemetostat will be administered at escalating doses. Dose Expansion Part: Valemetostat will be administered at 2 or more dose levels.
  • Darolutamide — DRUG
    Dose Escalation Part: Darolutamide will be administered at a standard dose. Dose Expansion Part: Darolutamide will be administered at a standard dose.

Study Details

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

Key Dates

Start date
Dec 3, 2025
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (Dose Escalation)
    Participants will receive valemetostat at escalating doses in combination with darolutamide.
  • Experimental: Part 2 (Dose Expansion)
    Participants will receive valemetostat at 2 or more dose levels in combination with darolutamide.

Primary Outcome Measure

Part 1: Number of participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 1 up to Day 28 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of California San Diego Moores Cancer CenterLa JollaCalifornia92037-0698-
Beth Isreal Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteNewtonMassachusetts02467-
Cancer & Hematology CenterGrand RapidsMichigan49546-2302-
Northwell Health Cancer Institute (START NY)Lake SuccessNew York11042-1118-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-4607-
NEXT OncologySan AntonioTexas78229-6028-
Virginia Cancer Specialists (NEXT Virginia)FairfaxVirginia22031-
Medical College Of WisconsinMilwaukeeWisconsin53226-3522-

Find similar trials in La Jolla, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California San Diego Moores Cancer Center· La Jolla, CABeth Isreal Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Newton, MACancer & Hematology Center· Grand Rapids, MINorthwell Health Cancer Institute (START NY)· Lake Success, NYCarolina Urologic Research Center· Myrtle Beach, SC

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