A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
← catalyst calendarNCT07244341 · readout in 530 d
Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With Bayer.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
60estimated
Sites
19
Countries
China, Ireland, Japan +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-03 | actual | When the study began enrolling |
| Primary completion | 2028-01-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-11-30 | estimated | The whole study's end, after follow-up |
| First posted | 2025-11-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metastatic Castration-resistant Prostate Cancer
Interventions
- Drug: Valemetostat — also filed as DS-3201
- Drug: Darolutamide — also filed as NUBEQA
Primary outcomes
what the primary-completion date above is the date OFPart 1: Number of participants with Dose-Limiting Toxicities (DLTs)
measured Day 1 up to Day 28
Part 1 and 2: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
measured From Screening up to approximately 5 years
Permalink · 4568.T's whole pipeline · Catalyst calendar · Every registered study · What changed