Clinical Trial

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)

Study acronym: TulmiSTAR-02
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
Protocol Amendment History 6 changes
notable Trial sites expanded: 25 -> 29 locations 2026-06-03
critical Primary endpoint(s) modified 2026-05-12
notable Enrollment increased: 155 -> 181 participants 2026-05-12
notable Primary completion pushed: 2032-06-04 -> 2032-08-02 2026-04-03
minor Completion pushed: 2032-06-04 -> 2032-08-02 2026-04-03
notable Trial sites expanded: 14 -> 20 locations 2026-04-02
Trial Details
NCT Number NCT07190300
Lead Sponsor Novartis Pharmaceuticals
Conditions Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Enrollment 181 participants
Start Date 2026-01-13
Primary Completion 2032-08-02 (estimated)
Study Completion 2032-08-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-23