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)
Recruiting now · Phase 1/Phase 2
Conditions studied: Progressive Metastatic Castrate Resistant Prostate Cancer
In brief
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).
Key facts
- Study ID
- NCT07206056
- Run by
- Novartis Pharmaceuticals
- People needed
- 188
- Starts
- 2025-10-15
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Sarah Cannon Research Institute — Denver, Colorado, United States (enrolling)
- Sarah Cannon Research Institute — Jacksonville, Florida, United States (enrolling)
- Emory University — Atlanta, Georgia, United States (enrolling)
- Wichita Urology Group PA — Wichita, Kansas, United States (enrolling)
- Mass General Hospital — Boston, Massachusetts, United States (enrolling)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (enrolling)
- Novartis Investigative Site — St Leonards, New South Wales, Australia (enrolling)
- Novartis Investigative Site — Melbourne, Victoria, Australia (enrolling)
- Novartis Investigative Site — Liverpool, Australia (enrolling)
- Novartis Investigative Site — Halifax, Nova Scotia, Canada (enrolling)
- Novartis Investigative Site — Beijing, China (enrolling)
- Novartis Investigative Site — Herlev, Denmark (enrolling)
- Novartis Investigative Site — Odense C, Denmark (enrolling)
- Novartis Investigative Site — Vejle, Denmark (enrolling)
- Novartis Investigative Site — Bordeaux, France (enrolling)
- Novartis Investigative Site — Paris, France (enrolling)
- Novartis Investigative Site — Paris, France (enrolling)
- Novartis Investigative Site — Düsseldorf, North Rhine-Westphalia, Germany (enrolling)
- Novartis Investigative Site — Milan, MI, Italy (enrolling)
- Novartis Investigative Site — Padova, PD, Italy (enrolling)
- Novartis Investigative Site — Orbassano, TO, Italy (enrolling)
- Novartis Investigative Site — Kuching, Sarawak, Malaysia (enrolling)
- Novartis Investigative Site — Tlalpan, Mexico City, Mexico (enrolling)
- Novartis Investigative Site — Poznan, Poland (enrolling)
Full record on ClinicalTrials.gov
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