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)
Start Date
1/13/2026
Completion Date
8/2/2032
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).
Detailed Description
The study consists of two phases: 1. Phase I: The Phase I part includes two groups: Part 1 will assess the combination of tulmimetostat with darolutamide (Group A), and Part 2 will assess tulmimetostat with abiraterone (Group B). The primary objective of Phase I is to determine the recommended dose escalations (RDEs) for each combination, with enrollment using a staggered approach between groups. Participants in both groups will continue androgen deprivation therapy (ADT) to maintain castrate testosterone levels (\<50 ng/dL or \<1.7 nmol/L), as determined by the investigator based on local guidelines. In Group B, abiraterone will be administered with an oral corticosteroid (prednisone or prednisolone) per local prescribing information. 2. Phase II: Phase II is a randomized, open-label, multicenter dose-expansion study to further evaluate the recommended dose(s) of tulmimetostat in combination with darolutamide and provide proof-of-concept for efficacy and safety. Participants will be randomized to receive tulmimetostat plus darolutamide or darolutamide alone. Eligible participants include those with metastatic hormone-sensitive prostate cancer (mHSPC) who are either de novo or recurrent, without prior radioligand therapy, but who may have received prior taxane-based chemotherapy and/or androgen receptor pathway inhibitors (ARPIs), excluding darolutamide. The study evaluates tulmimetostat-based combinations as potential treatment options for men with mHSPC. The study for each participant consists of a screening period, a study treatment period followed by a post treatment long-term follow-up.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Tulmimetostat
Darolutamide
Abiraterone
Conditions
Locations
Univ of Alabama at Birmingham
Birmingham, Alabama 35294-3300
United States
Uni Of Iowa Hospitals And Clinics
Iowa City, Iowa 52242
United States
University of Kansas Cancer Center
Westwood, Kansas 66205
United States
Wichita Urology Group PA
Wichita, Kansas 67226
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Medical University of South Carolina MUSC
Charleston, South Carolina 29425
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Novartis Investigative Site
Camperdown, New South Wales 2050
Australia
Novartis Investigative Site
Wollongong, New South Wales 2500
Australia
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul 90610-001
Brazil
Novartis Investigative Site
Montreal, Quebec H2X 1R9
Canada
Novartis Investigative Site
Guangzhou, 510060
China
Novartis Investigative Site
Créteil, 94010
France
Novartis Investigative Site
Lille, 59020
France
Novartis Investigative Site
Nantes, 44093
France
Novartis Investigative Site
Jena, Thuringia 07740
Germany
Novartis Investigative Site
Essen, 45147
Germany
Novartis Investigative Site
Hong Kong, 999077
Hong Kong
Novartis Investigative Site
Budapest, H 1122
Hungary
Novartis Investigative Site
Budapest, H-1083
Hungary
Novartis Investigative Site
Szeged, 6725
Hungary
Novartis Investigative Site
Rozzano, MI 20089
Italy
Novartis Investigative Site
Verona, VR 37134
Italy
Novartis Investigative Site
Seoul, 05505
South Korea
Novartis Investigative Site
Seoul, 06591
South Korea
Novartis Investigative Site
Madrid, 28034
Spain
Novartis Investigative Site
Madrid, 28040
Spain
Novartis Investigative Site
Madrid, 28222
Spain
Novartis Investigative Site
Ankara, Sihhiye-Altindag 06230
Turkey (Türkiye)
Novartis Investigative Site
London, W1G 6AD
United Kingdom