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NCT07244341
A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Phase 1 trial testing Valemetostat in Metastatic Castration-resistant Prostate Cancer in 60 participants. Currently enrolling.
31 January 2028
Quick facts
| Lead sponsor | Daiichi Sankyo |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 3 December 2025 |
| Primary completion | 31 January 2028 |
| Estimated completion | 30 November 2029 |
| Sites | 6 locations across Japan, United States |
Drugs / interventions tested
- Valemetostat (VALEMETOSTAT) — full drug profile →
- Darolutamide (darolutamide) — full drug profile →
Conditions studied
- Metastatic Castration-resistant Prostate Cancer — all drugs for Metastatic Castration-resistant Prostate Cancer →
Sponsor
Daiichi Sankyo — full company profile →
Who can join
18 and older, male only, with Metastatic Castration-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07244341
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Valemetostat
Trials testing the same drug.
- NCT06294548 — A Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC · Phase 1, PHASE2 · recruiting
- NCT05683171 — A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory F · Phase 1, PHASE2 · recruiting
- NCT05633979 — Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ult · Phase 1 · active not recruiting
- NCT04388852 — DS3201 and Ipilimumab for the Treatment of Metastatic Prostate, Urothelial and Renal Cell Cancers · Phase 1 · active not recruiting
- NCT03930953 — A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants · Phase 1, PHASE2 · active not recruiting
Other recruiting trials for Metastatic Castration-resistant Prostate Cancer
Currently open trials in the same condition.
- NCT07142551 — Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response · Phase 2 · recruiting
- NCT07288359 — Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and · Phase 1, PHASE2 · recruiting
- NCT07213674 — A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic · Phase 3 · recruiting
- NCT07189403 — A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resist · Phase 1 · recruiting
- NCT06922318 — The COSMYC Trial (COmbined Suppression of MYC) · Phase 2 · recruiting
Other Daiichi Sankyo trials
Trials by the same sponsor.
- NCT07474649 — A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events · Phase 3 · not yet recruiting
- NCT07206472 — A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholestero · active not recruiting
- NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies · Phase 1, PHASE2 · recruiting
- NCT07268625 — Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorv · Phase 1 · completed
- NCT07189403 — A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resist · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07244341 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
- Last refreshed: 4 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07244341.
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