RecruitingPhase 1Phase 2NCT07206056

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)

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

Sponsor

Novartis Pharmaceuticals

Enrollment

188 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Progressive Metastatic Castrate Resistant Prostate Cancer

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).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (TulmiSTAR-01) is testing a combination of two investigational drugs — tulmimetostat and luxdegalutamide — in men with advanced prostate cancer that has stopped responding to hormone therapy (called metastatic castrate-resistant prostate cancer, or mCRPC). Both drugs target different pathways that help prostate cancer grow. **You may be eligible if...** - You are a man aged 18 or older - You have confirmed advanced prostate cancer that has spread to other parts of the body - Your cancer has continued to grow despite hormone treatment (testosterone is at castrate levels) - Your cancer has progressed after treatment with at least one modern hormone-blocking drug (like enzalutamide or abiraterone) - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - Your prostate cancer has features of neuroendocrine or small cell cancer - You have active or untreated brain metastases - You have had more than the allowed number of prior chemotherapy regimens - You have significant heart, liver, or blood count problems - You have had certain prior treatments that would disqualify you based on the specific study phase Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTulmimetostat DL1 QD

Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

DRUGTulmimetostat DL2 QD

Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

DRUGTulmimetostat DL3 QD

Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

DRUGTulmimetostat Doses 1 or 2 QD

Part 1b (dose expansion and optimization): tulmimetostat doses 1 or 2 QD

DRUGTulmimetostat RP2D QD

Part 2: tulmimetostat Recommended Phase 2 Dose (RP2D) QD

DRUGJSB462 Dose 1 QD

JSB462 Dose 1 QD

DRUGJSB462 Dose 2 QD

JSB462 Dose 2 QD

DRUGJSB462 QD

The dose of JSB462 QD will be determined based on the totality of data from Part 1a

DRUGStandard of Care (SoC)

Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator

Locations(29)

Sarah Cannon Research Institute

Denver, Colorado, United States

Sarah Cannon Research Institute

Jacksonville, Florida, United States

Wichita Urology Group PA

Wichita, Kansas, United States

Mass General Hospital

Boston, Massachusetts, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Novartis Investigative Site

St Leonards, New South Wales, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Liverpool, Australia

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Herlev, Denmark

Novartis Investigative Site

Odense C, Denmark

Novartis Investigative Site

Vejle, Denmark

Novartis Investigative Site

Bordeaux, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Düsseldorf, North Rhine-Westphalia, Germany

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Padova, PD, Italy

Novartis Investigative Site

Orbassano, TO, Italy

Novartis Investigative Site

Kuching, Sarawak, Malaysia

Novartis Investigative Site

Poznan, Poland

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Sutton, Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07206056