A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
NCT07103018
This study is recruiting at 12 US sites in 8 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Metastatic Castration-resistant Prostate Cancer
- Metastatic Castration-Resistant Prostate Cancer Patients
- Metastatic Castration-resistant Prostate Cancer, mCRPC
- mCRPC
- mCRPC (Metastatic Castration-resistant Prostate Cancer)
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 years and older
- Sex
- Male
- Healthy volunteers
- Not accepted
- Sponsor
- K36 Therapeutics, Inc.
- Last updated on ClinicalTrials.gov
- July 9, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- University of California San Francisco · San Francisco, CA
Florida · 2
- Sylvester Comprehensive Cancer Center · Miami, FL
- Hematology Oncology Associates of the Treasure Coast · Port Saint Lucie, FL
Minnesota · 1
- Mayo Clinic · Rochester, MN
New York · 4
- START New York Long Island, LLC · New Hyde Park, NY
- Columbia University Irving Medical Center · New York, NY
- Memorial Sloan Kettering Cancer Center · New York, NY
- NYU Langone Health · New York, NY
North Carolina · 1
- Duke Cancer Center · Durham, NC
South Carolina · 1
- Carolina Urologic Research Center, the START Center for Cancer Research · Myrtle Beach, SC
Texas · 1
- USA Clinical Trials · San Antonio, TX
Wisconsin · 1
- University of Wisconsin · Madison, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.