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NCT07190300 · ClinicalTrials.gov registry record · Phase 1
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
A Phase 1 study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 155
- Enrollment target
- 14
- Study locations
NCT07190300: Recruiting Phase 1 study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), sponsored by Novartis Pharmaceuticals.
NCT07190300 is a Phase 1 study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 155 participants, above the 52-participant average among 5 other Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) trials with a reported enrollment target (198% higher). The trial reports 14 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07190300, a Phase 1 study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 155 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
Primary Outcome
A dose-limiting toxicity is defined as an adverse event or abnormal laboratory value, not clearly due to underlying disease or extraneous causes, that occurs within the first 28 days of treatment with tulmimetostat 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-escalation decisions, DLTs will be considered and included in the Bayesia
Conditions Studied
Interventions
- DRUG Darolutamide
- DRUG Abiraterone
- DRUG Tulmimetostat
Study Locations (14)
Other
- Novartis Investigative Site - Guangzhou
- Novartis Investigative Site - Créteil
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Hong Kong
- Novartis Investigative Site - Budapest
- Novartis Investigative Site - Szeged
- Novartis Investigative Site - Seoul
- Novartis Investigative Site - Seoul
- Novartis Investigative Site - Madrid
- Novartis Investigative Site - Madrid
Kansas
- Wichita Urology Group PA - Wichita
South Carolina
- Carolina Urologic Research Center - Myrtle Beach
New South Wales
- Novartis Investigative Site - Wollongong
Madrid
- Novartis Investigative Site - Majadahonda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2026-01-13 |
| Est. Completion | 2032-06-04 |
| Phase | Phase 1 |
What NCT07190300 shows while recruiting
NCT07190300 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 52-participant average among 5 other Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) trials with a reported enrollment target (198% higher).
The record links to 1 condition, with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) appearing as the primary indexed condition, and to 3 interventions - of which Darolutamide is the first listed.
NCT07190300 lists 14 locations in 5 states (Other, Kansas, South Carolina).
Frequently Asked Questions
What is clinical trial NCT07190300 about?
NCT07190300 is a clinical study titled "TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)". The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
What is the current status of trial NCT07190300?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 155 participants. The study started on 2026-01-13. Estimated completion is 2032-06-04.
What conditions does trial NCT07190300 study?
This clinical trial studies the following conditions: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
What interventions are being tested in trial NCT07190300?
The interventions under investigation include: Darolutamide (DRUG), Abiraterone (DRUG), Tulmimetostat (DRUG).
Who is sponsoring clinical trial NCT07190300?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07190300 being conducted?
This trial has 14 study locations across Kansas, South Carolina, New South Wales, Madrid. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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