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)
Recruiting now · Phase 1/Phase 2
Conditions studied: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
In brief
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).
Key facts
- Study ID
- NCT07190300
- Run by
- Novartis Pharmaceuticals
- People needed
- 181
- Starts
- 2026-01-13
- Expected to finish
- 2032-08-02
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — London, United Kingdom (enrolling)
- Uni Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States (enrolling)
- University of Kansas Cancer Center — Westwood, Kansas, United States (enrolling)
- Wichita Urology Group PA — Wichita, Kansas, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- Medical University of South Carolina MUSC — Charleston, South Carolina, United States (enrolling)
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
- Univ of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- Novartis Investigative Site — Wollongong, New South Wales, Australia (enrolling)
- Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- Novartis Investigative Site — Montreal, Quebec, Canada (enrolling)
- Novartis Investigative Site — Guangzhou, China (enrolling)
- Novartis Investigative Site — Créteil, France (enrolling)
- Novartis Investigative Site — Lille, France (enrolling)
- Novartis Investigative Site — Nantes, France (enrolling)
- Novartis Investigative Site — Jena, Thuringia, Germany (enrolling)
- Novartis Investigative Site — Essen, Germany (enrolling)
- Novartis Investigative Site — Hong Kong, Hong Kong (enrolling)
- Novartis Investigative Site — Budapest, Hungary (enrolling)
- Novartis Investigative Site — Budapest, Hungary (enrolling)
- Novartis Investigative Site — Szeged, Hungary (enrolling)
- Novartis Investigative Site — Rozzano, MI, Italy (enrolling)
- Novartis Investigative Site — Verona, VR, Italy (enrolling)
- Novartis Investigative Site — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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