RecruitingPhase I/II🇵🇱 PolandMale onlyEN originalProstate cancerMetastatic / advanced

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)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Dorosły mężczyzna w wieku 18 lat lub starszy
  • Potwierdzony rак prostaty (potwierdzona wcześniej biopsją)
  • Co najmniej jeden widoczny przerzut nowotworu w obrazowaniu (TK, rezonans lub scyntygrafia kostna)
  • Rak prostaty niezależny od hormonów, który się rozwija mimo terapii
  • Bardzo niska zawartość testosteronu we krwi (castrat level)
  • Wcześniejsze bezskuteczne leczenie za pomocą co najmniej jednego leku z grupy ARPI
  • W zależności od etapu: wcześniejsza chemioterapia możliwa (maksymalnie określona liczba linii)

✗ Disqualifies

  • Wcześniejsze leczenie inhibitorami PRC2 lub podobnymi lekami
  • Wcześniejsze leczenie białkami degradujący ą receptor androgenowy
  • Alergia lub uczulenie na składniki leku
  • Uczestnictwo w innym badaniu klinicznym w ciągu ostatnich 28 dni

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 21, 2026
Sex
Male only

Therapies / drugs in trial

Locations (35)

Sarah Cannon Research Institute

Denver, United States

Sarah Cannon Research Institute

Jacksonville, United States

Emory University

Atlanta, United States

Wichita Urology Group PA

Wichita, United States

Mass General Hospital

Boston, United States

Duke University Medical Center

Durham, United States

Cleveland Clinic Foundation

Cleveland, United States

Fred Hutchinson Cancer Research Center

Seattle, United States

Novartis Investigative Site

St Leonards, Australia

Novartis Investigative Site

Melbourne, Australia

Novartis Investigative Site

Liverpool, Australia

Novartis Investigative Site

Halifax, 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, Germany

Novartis Investigative Site

Jena, Germany

Novartis Investigative Site

Milan, Italy

Novartis Investigative Site

Padova, Italy

Novartis Investigative Site

Orbassano, Italy

Novartis Investigative Site

Kuching, Malaysia

Novartis Investigative Site

Tlalpan, Mexico

Novartis Investigative Site

Poznan, Poland

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Santiago Compostela, Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Sutton, United Kingdom

Novartis Investigative Site

London, United Kingdom

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/19/2026.

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