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