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)

Active:	Yes
Cancer Type:	Prostate Cancer Unknown Primary	NCT ID:	NCT07206056
Trial Phases:	Phase I Phase II	Protocol IDs:	CDZR123A12107 (primary) NCI-2025-08418 2025-521880-10-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT07206056

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).

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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