Clinical Trial

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

Study acronym: STRIKE-001
Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2025-07-28; most recent amendment 2026-07-08.
Status change: Not Yet Recruiting → Recruiting 2025-10-07
Trial Details
NCT Number NCT07103018
Lead Sponsor K36 Therapeutics, Inc.
Conditions Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer Patients, Metastatic Castration-resistant Prostate Cancer, mCRPC, mCRPC, mCRPC (Metastatic Castration-resistant Prostate Cancer)
Enrollment 144 participants
Start Date 2025-11-21
Primary Completion 2027-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-09