OncoMatch/Clinical Trials/NCT07103018
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
Is NCT07103018 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including KTX-2001 and KTX-2001 + Darolutamide (NUBEQA®) for metastatic castration-resistant prostate cancer.
Treatment: KTX-2001 · KTX-2001 + Darolutamide (NUBEQA®) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: androgen receptor pathway inhibitor (abiraterone, enzalutamide, darolutamide, apalutamide)
Participants should have progressed on or after receiving an ARPI (eg, abiraterone, enzalutamide, darolutamide, or apalutamide).
Lab requirements
Blood counts
neutrophils >1 × 10^9/L, platelet count >100 × 10^9/L, hemoglobin >9 g/dL with no prior transfusions within 2 weeks
Kidney function
creatinine clearance >50 mL/min by serum creatinine
Liver function
total bilirubin ≤1.5× ULN, total bilirubin <3× ULN for participants with documented Gilbert's syndrome, AST and ALT ≤2.5× ULN; in case of liver metastases, AST and ALT <5× ULN is allowed
Cardiac function
QT interval corrected by Fridericia's formula >470 msec at screening; unstable cardiovascular function (see exclusion criteria for details)
Adequate renal function (creatinine clearance >50 mL/min by serum creatinine). Adequate hepatic function (total bilirubin ≤1.5× ULN, total bilirubin <3× ULN for participants with documented Gilbert's syndrome, AST and ALT ≤2.5× ULN). In case of liver metastases, AST and ALT <5× ULN is allowed. Adequate hematological function (neutrophils >1 × 10^9/L, platelet count >100 × 10^9/L, hemoglobin >9 g/dL) with no prior transfusions within 2 weeks. QT interval corrected by Fridericia's formula >470 msec at screening. Unstable cardiovascular function defined as: symptomatic ischemia, uncontrolled clinically significant conduction abnormalities, congestive heart failure NYHA Class ≥3, myocardial infarction within 3 months, hypertension that cannot be controlled (persistent >150/90 mmHg despite optimal medical therapy).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Francisco · San Francisco, California
- Sylvester Comprehensive Cancer Center · Miami, Florida
- Hematology Oncology Associates of the Treasure Coast · Port Saint Lucie, Florida
- Mayo Clinic · Rochester, Minnesota
- START New York Long Island, LLC · New Hyde Park, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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