A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
Public ClinicalTrials.gov record NCT07103018. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1, Dose-Escalation Study of KTX2001 (an NSD2 Inhibitor) Alone and in Combination With Darolutamide for Metastatic Castration-Resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07103018
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 144 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2025
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2028
- Last update posted
- Jul 8, 2026
2025 – 2028
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 | Recruiting |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | Recruiting |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| START New York Long Island, LLC | New Hyde Park | New York | 11042 | Recruiting |
| NYU Langone Health | New York | New York | 10016 | Recruiting |
| Columbia University Irving Medical Center | New York | New York | 10032 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10032 | Recruiting |
| Duke Cancer Center | Durham | North Carolina | 27710 | Recruiting |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Not yet recruiting |
| Carolina Urologic Research Center, the START Center for Cancer Research | Myrtle Beach | South Carolina | 29572 | Recruiting |
| USA Clinical Trials | San Antonio | Texas | 78229 | Recruiting |
| University of Wisconsin | Madison | Wisconsin | 53705 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07103018, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07103018 live on ClinicalTrials.gov.