drugset / Trial / NCT07103018

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

NCT07103018

Phase 1 Recruiting 144 enrolled K36 Therapeutics, Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-11-21
Primary completion
2027-09
Completion
2028-09

Drugs

EvaluationDrugModalityDoseRoute
Subject KTX2001 Unknown Oral
Background Darolutamide Other / unclassified 600 mg Oral

Indications