NCT07206056

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)

TulmiSTAR-01: A Two-part, Phase I Dose Escalation and Expansion Followed by a Randomized, Open-label Multicenter, Phase II Study to Assess the Safety and Efficacy of the Combination of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) vs Standard of Care in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progressive Metastatic Castrate Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Tulmimetostat DL1 QD	Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))
DRUG	Tulmimetostat DL2 QD	Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))
DRUG	Tulmimetostat DL3 QD	Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))
DRUG	Tulmimetostat Doses 1 or 2 QD	Part 1b (dose expansion and optimization): tulmimetostat doses 1 or 2 QD
DRUG	Tulmimetostat RP2D QD	Part 2: tulmimetostat Recommended Phase 2 Dose (RP2D) QD
DRUG	JSB462 Dose 1 QD	JSB462 Dose 1 QD
DRUG	JSB462 Dose 2 QD	JSB462 Dose 2 QD
DRUG	JSB462 QD	The dose of JSB462 QD will be determined based on the totality of data from Part 1a
DRUG	Standard of Care (SoC)	Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator

Timeline

• Start date: 2025-10-15
• Primary completion: 2029-11-09
• Completion: 2030-12-01
• First posted: 2025-10-03
• Last updated: 2026-04-16

Locations

27 sites across 12 countries: United States, Australia, Canada, China, Denmark, France, Italy, Malaysia, Poland, Singapore, Spain, United Kingdom

Regulatory

• FDA-regulated drug study