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)
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
Sponsor: Novartis Pharmaceuticals
Listed as NCT07206056, this observational or N/A phase trial focuses on Progressive Metastatic Castrate Resistant Prostate Cancer and remains actively recruiting participants. Sponsored by Novartis Pharmaceuticals, it has been updated 7 times since 2025, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
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Apr 17, 2026 — May 4, 2026 [daily]
Recruiting
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Apr 16, 2026 — Apr 17, 2026 [daily]
Recruiting
Phase: PHASE1/PHASE2 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE1/PHASE2
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE1/PHASE2
▶ Show 2 earlier versions
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Dec 2025 — Feb 2026 [monthly]
Recruiting PHASE1/PHASE2
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE1/PHASE2
First recorded
Oct 2025
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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).
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .