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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 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.

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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).

Conditions Studied

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

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

FieldValue
Enrollment Target 155 participants
Start Date 2026-01-13
Est. Completion 2032-06-04
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07190300

The ClinicalTrials.gov registry entry for NCT07190300 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 52-participant average among 5 other Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) trials with a reported enrollment target (198% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 14 study locations spanning 5 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.