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)
Public ClinicalTrials.gov record NCT07206056. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT07206056
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 188 participants
Conditions and interventions
Interventions
- JSB462 Dose 1 QD Drug
- JSB462 Dose 2 QD Drug
- JSB462 QD Drug
- Standard of Care (SoC) Drug
- Tulmimetostat DL1 QD Drug
- Tulmimetostat DL2 QD Drug
- Tulmimetostat DL3 QD Drug
- Tulmimetostat Doses 1 or 2 QD Drug
- Tulmimetostat RP2D QD Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 14, 2025
- Primary completion
- Nov 8, 2029
- Completion
- Nov 30, 2030
- Last update posted
- May 7, 2026
2025 – 2030
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | Recruiting |
| Sarah Cannon Research Institute | Jacksonville | Florida | 32256 | Recruiting |
| Wichita Urology Group PA | Wichita | Kansas | 67226 | Recruiting |
| Mass General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07206056, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2026 · Synced May 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07206056 live on ClinicalTrials.gov.