TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL

Enrollment

203

Participants

Timeline

Start Date

November 3, 2025

Primary Completion Date

May 14, 2032

Study Completion Date

May 14, 2032

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions

DRUG

Tulmimetostat

Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

DRUG

Darolutamide

600 mg is administered orally BID

DRUG

Abiraterone

abiraterone 1000 mg is administered orally QD