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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: Recruiting Phase 1 study of Progressive Metastatic Castrate Resistant Prostate Cancer, sponsored by Novartis Pharmaceuticals.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (213% higher). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the first 28 days of treatment with tulmimetostat and JSB462 and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. For the purpose of dose-escal
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 |
What NCT07206056 shows while recruiting
NCT07206056 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (213% higher).
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 lists 18 locations in 10 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07206056's enrollment target sits among peer trials
188 289th of 2000 higher than 1,711 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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