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NCT07206056 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Progressive Metastatic Castrate Resistant Prostate Cancer, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 188
- Enrollment target
- 18
- Study locations
NCT07206056 is a Phase 1 study of Progressive Metastatic Castrate Resistant Prostate Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 188 participants. The trial reports 18 study locations across 10 states.
The verdict
NCT07206056, a Phase 1 study of Progressive Metastatic Castrate Resistant Prostate Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 188 participants
- Enrollment target
- 18
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Tulmimetostat DL1 QD
- DRUG Tulmimetostat DL2 QD
- DRUG Tulmimetostat DL3 QD
- DRUG Tulmimetostat Doses 1 or 2 QD
- DRUG Tulmimetostat RP2D QD
Study Locations (18)
Other
- Novartis Investigative Site - Liverpool
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Vejle
- Novartis Investigative Site - Bordeaux
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Poznan
- Novartis Investigative Site - Singapore
- Novartis Investigative Site - Singapore
- Novartis Investigative Site - Madrid
Colorado
- Sarah Cannon Research Institute - Denver
Florida
- Sarah Cannon Research Institute - Jacksonville
Kansas
- Wichita Urology Group PA - Wichita
Washington
- Fred Hutchinson Cancer Research Center - Seattle
New South Wales
- Novartis Investigative Site - St Leonards
Victoria
- Novartis Investigative Site - Melbourne
MI
- Novartis Investigative Site - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2025-10-15 |
| Est. Completion | 2030-12-17 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07206056
The ClinicalTrials.gov registry entry for NCT07206056 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Progressive Metastatic Castrate Resistant Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Tulmimetostat DL1 QD is the first listed.
NCT07206056 reports 18 study locations spanning 10 distinct geographic areas - top geographies include Other, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT07206056 about?
NCT07206056 is a clinical study titled "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)". 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).
What is the current status of trial NCT07206056?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 188 participants. The study started on 2025-10-15. Estimated completion is 2030-12-17.
What conditions does trial NCT07206056 study?
This clinical trial studies the following conditions: Progressive Metastatic Castrate Resistant Prostate Cancer.
What interventions are being tested in trial NCT07206056?
The interventions under investigation include: Tulmimetostat DL1 QD (DRUG), Tulmimetostat DL2 QD (DRUG), Tulmimetostat DL3 QD (DRUG), Tulmimetostat Doses 1 or 2 QD (DRUG), Tulmimetostat RP2D QD (DRUG).
Who is sponsoring clinical trial NCT07206056?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07206056 being conducted?
This trial has 18 study locations across Colorado, Florida, Kansas, Washington, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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