Actively Recruiting
A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Led by Daiichi Sankyo · Updated on 2026-02-04
60
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).
CONDITIONS
Official Title
A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males 18 years of age or older at the time of consent
- Histologically confirmed adenocarcinoma of the prostate including neuroendocrine differentiation except pure small cell carcinoma
- Evidence of disease progression per PCWG3 modified RECIST v1.1 criteria
- Radiographic confirmation of metastatic disease by CT, MRI, or bone scan
- Ongoing androgen deprivation therapy initiated at least 4 weeks prior and continued during the trial
- Baseline PSA level of 2 ng/mL or higher
- Prior therapy with androgen receptor pathway inhibitors
- ECOG performance status of 0 or 1 within 28 days prior to enrollment
- Willing and able to provide adequate fresh or archival tumor samples; pretreatment biopsy required if not contraindicated
- If capable of producing sperm, agrees to use contraception and not donate or freeze sperm during and for 3 months after treatment
You will not qualify if you...
- Prior treatment with epigenetic agents including EZH1, EZH2, EZH1/2, or PRC2 inhibitors
- Presence of super scan on baseline bone scan
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis requiring treatment
- Uncontrolled or significant cardiovascular disease
- Prior malignancy active within the past 3 years except certain locally curable cancers
- Active or uncontrolled hepatitis B infection
- Active or uncontrolled hepatitis C infection
- Active or uncontrolled HIV infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572-4607
Actively Recruiting
2
NEXT Oncology
San Antonio, Texas, United States, 78229-6028
Actively Recruiting
3
Virginia Cancer Specialists (NEXT Virginia)
Fairfax, Virginia, United States, 22031-2171
Actively Recruiting
4
Kobe City Med Cen Gen Hosp.
Kobe, Japan, 650-0047
Actively Recruiting
5
Cancer Institute Hospital of JFCR
Kōtoku, Japan, 135-8550
Actively Recruiting
6
Toho University Sakura Medical Center
Sakura-shi, Japan, 285-8741
Actively Recruiting
Research Team
C
Contact for Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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