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 (Jun 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
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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 →Frequently asked questions
Is NCT07103018 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received androgen receptor pathway inhibitor.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages