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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The purpose of this study is to evaluate the safety, tolerability, and efficacy of two different treatment combinations of tulmimetostat in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer (mHSPC). Phase I aims to determine the recommended dose(s) for expansion (RDE) of tulmimetostat in combination with darolutamide or abiraterone. Phase II is designed to further evaluate the efficacy and safety of tulmimetostat in combination with darolutamide compared with darolutamide alone in participants with mHSPC.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyźni w wieku co najmniej 18 lat z rozsianym rakiem prostaty, który reaguje na hormony (niezależnie czy rozpoznany niedawno, czy nawrócił).
- •Poziom testosteronu we krwi nie przekracza 1,7 nM (poniżej ustalonego progu).
- •Ogólny stan zdrowia pacjenta pozwala na udział w badaniu (w skali 0-2 według ECOG).
- •Wystarczająca ilość zdrowych komórek krwi i prawidłowe funkcjonowanie narządów.
- •Pacjent musiał rozpocząć terapię hormonalną (ADT) od 1 do 12 miesięcy przed badaniem i być gotów ją kontynuować.
- •Możliwe wcześniejsze leczenie lekiem z grupy taksanów (jeśli nie nastąpiło pogorszenie choroby).
- •Dopuszczalne jest wcześniejsze stosowanie leków blokujących receptory androgenowe (ARPI) w niektórych przypadkach, pod warunkiem przerwania terapii.
✗ Disqualifies
- •Pacjenci z rakiem prostaty o cechach neuroendokrynnych lub drobnokomórkowych.
- •Pacjenci, u których choroba postępuje pomimo stosowanego leczenia.
- •Pacjenci, którzy obecnie stosują lek z grupy darolutamid.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 29, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (31)
Univ of Alabama at Birmingham
Birmingham, United States
Uni Of Iowa Hospitals And Clinics
Iowa City, United States
University of Kansas Cancer Center
Westwood, United States
Wichita Urology Group PA
Wichita, United States
Duke University Medical Center
Durham, United States
Medical University of South Carolina MUSC
Charleston, United States
Carolina Urologic Research Center
Myrtle Beach, United States
Huntsman Cancer Institute
Salt Lake City, United States
Novartis Investigative Site
Camperdown, Australia
Novartis Investigative Site
Wollongong, Australia
Novartis Investigative Site
Porto Alegre, Brazil
Novartis Investigative Site
Montreal, Canada
Novartis Investigative Site
Guangzhou, China
Novartis Investigative Site
Créteil, France
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
Jena, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Szeged, Hungary
Novartis Investigative Site
Rozzano, Italy
Novartis Investigative Site
Verona, Italy
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Ankara, Turkey (Türkiye)
Novartis Investigative Site
London, United Kingdom
Trial contact
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/30/2026.
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