An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)
Start Date
10/15/2025
Completion Date
12/1/2030
Summary
This is a two-part, Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).
Detailed Description
The Phase 1 study, comprised of Parts 1a and 1b, aims to assess the safety and tolerability of the combination of tulmimetostat and JSB462: 1. Part 1a is the parallel dose escalation that aims to determine the recommended dose(s) of tulmimetostat and JSB462, in combination, for further exploration. 2. Part 1b is the dose expansion/optimization that aims to determine the recommended dose of the combination for Phase II. The purpose of the Phase II study (Part 2) is to compare the combination of tulmimetostat with JSB462 in terms of the biochemical response as assessed by PSA50 compared to the standard of care (SoC) in adult men with progressive, taxane-naive mCRPC.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Tulmimetostat DL1 QD
Tulmimetostat DL2 QD
Tulmimetostat DL3 QD
Tulmimetostat Doses 1 or 2 QD
Tulmimetostat RP2D QD
JSB462 Dose 1 QD
JSB462 Dose 2 QD
JSB462 QD
Standard of Care (SoC)
Conditions
Locations
Sarah Cannon Research Institute
Denver, Colorado 80218
United States
Sarah Cannon Research Institute
Jacksonville, Florida 32256
United States
Emory University
Atlanta, Georgia 30329
United States
Wichita Urology Group PA
Wichita, Kansas 67226
United States
Mass General Hospital
Boston, Massachusetts 02114
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-1024
United States
Novartis Investigative Site
St Leonards, New South Wales 2065
Australia
Novartis Investigative Site
Melbourne, Victoria 3000
Australia
Novartis Investigative Site
Liverpool, 2170
Australia
Novartis Investigative Site
Halifax, Nova Scotia B3H 2Y9
Canada
Novartis Investigative Site
Beijing, 100021
China
Novartis Investigative Site
Herlev, DK-2730
Denmark
Novartis Investigative Site
Odense C, 5000
Denmark
Novartis Investigative Site
Vejle, DK-7100
Denmark
Novartis Investigative Site
Bordeaux, 33076
France
Novartis Investigative Site
Paris, 75015
France
Novartis Investigative Site
Paris, 75231
France
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia 40225
Germany
Novartis Investigative Site
Milan, MI 20133
Italy
Novartis Investigative Site
Padova, PD 35128
Italy
Novartis Investigative Site
Orbassano, TO 10043
Italy
Novartis Investigative Site
Kuching, Sarawak 93586
Malaysia
Novartis Investigative Site
Tlalpan, Mexico City 14050
Mexico
Novartis Investigative Site
Poznan, 60-192
Poland
Novartis Investigative Site
Singapore, 119074
Singapore
Novartis Investigative Site
Singapore, S308433
Singapore
Novartis Investigative Site
Santiago Compostela, A Coruna 15706
Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona 08907
Spain
Novartis Investigative Site
Madrid, 28009
Spain
Novartis Investigative Site
Madrid, 28041
Spain
Novartis Investigative Site
Sutton, Surrey SM2 5PT
United Kingdom
Novartis Investigative Site
London, W1G 6AD
United Kingdom