RecruitingPhase IMale onlyEN originalProstate cancerMetastatic / advanced

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

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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

Study K36-MCRPC-001 is the first in human clinical trial testing KTX-2001 alone and with darolutamide in men with metastatic castration-resistant prostate cancer. The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic castration-resistant prostate cancer, and measuring how the drug(s) behaves in the body.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Zaawansowany rak prostaty oporny na leczenie hormonalne (potwierdzony obrazami: skan kostny, CT lub rezonans magnetyczny)
  • Wcześniejsze niepowodzenie leczenia inhibitorami (np. abiraterone, enzalutamide, darolutamide, apalutamide)
  • Dobra funkcja nerek (klirens kreatyniny > 50 mL/min)
  • Dobra funkcja wątroby (prawidłowe parametry wątroby)
  • Prawidłowe liczby krwinek (neutrofile > 1 × 10⁹/L, płytki > 100 × 10⁹/L, hemoglobina > 9 g/dL)
  • Dobrz ogólny stan zdrowia (zdolność do udziału w badaniu)

✗ Disqualifies

  • Przerzuty do mózgu, które nie są kontrolowane lub wymagają sterydów
  • Ucisk na rdzeń kręgowy powodujący objawy, który nie został leczony
  • Aktywna poważna infekcja lub zagrażające życiu schorzenia, które mogą wpłynąć na bezpieczeństwo

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 9, 2026
Sex
Male only

Therapies / drugs in trial

Locations (13)

University of California San Francisco

San Francisco, United States

Sylvester Comprehensive Cancer Center

Miami, United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, United States

Mayo Clinic

Rochester, United States

START New York Long Island, LLC

New Hyde Park, United States

NYU Langone Health

New York, United States

Columbia University Irving Medical Center

New York, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Duke Cancer Center

Durham, United States

The Ohio State University Comprehensive Cancer Center

Columbus, United States

Carolina Urologic Research Center, the START Center for Cancer Research

Myrtle Beach, United States

USA Clinical Trials

San Antonio, United States

University of Wisconsin

Madison, United States

Trial contact

K36 Clinical Operations

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/10/2026.

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