Actively Recruiting
Phase 1 Study of KTX-2001 Alone and With Darolutamide for Men With Metastatic Castration-Resistant Prostate Cancer
Led by K36 Therapeutics, Inc. · Updated on 2026-07-09
144
Participants Needed
13
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating KTX-2001 alone and in combination with darolutamide in men with metastatic castration-resistant prostate cancer mCRPC. This first-in-human, open-label Phase 1 study aims to assess the safety, dosage levels, and preliminary effectiveness of KTX-2001. The study also examines how these drugs behave in the body, intending to establish recommended doses for future research. Participants will receive escalating doses of KTX-2001 either alone or combined with darolutamide, an oral androgen receptor pathway inhibitor given at 600 mg twice daily total 1200 mg. The study has two parts Part A tests KTX-2001 monotherapy, and Part B tests KTX-2001 with darolutamide. Dose escalation occurs sequentially to determine the maximum tolerated dose and recommended Phase 2 dose. Participants will be monitored closely for dose-limiting toxicities over 21 days and overall safety up to three years. Assessments include pharmacokinetic measurements of drug concentrations in plasma and regular evaluations of health and side effects. Tissue biopsies of metastatic sites may be collected if safe and feasible. The study will continue until September 2028, with ongoing safety and efficacy follow-up throughout this period.
CONDITIONS
Brief Title
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
Research Team
K
K36 Clinical Operations
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