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NCT07103018 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by K36 Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
- 13
- Study locations
NCT07103018 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC) that is actively recruiting participants, run by K36 Therapeutics. The registered enrollment target is 144 participants, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (27% lower). The trial reports 13 study locations across 9 states.
The verdict
NCT07103018, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC), is actively recruiting participants, sponsored by K36 Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
- 13
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG KTX-2001
- DRUG KTX-2001 + Darolutamide (NUBEQA®)
Study Locations (13)
New York
- START New York Long Island, LLC - New Hyde Park
- NYU Langone Health - New York
- Columbia University Irving Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Florida
- Sylvester Comprehensive Cancer Center - Miami
- Hematology Oncology Associates of the Treasure Coast - Port Saint Lucie
California
- University of California San Francisco - San Francisco
Minnesota
- Mayo Clinic - Rochester
North Carolina
- Duke Cancer Center - Durham
Ohio
- The Ohio State University Comprehensive Cancer Center - Columbus
South Carolina
- Carolina Urologic Research Center, the START Center for Cancer Research - Myrtle Beach
Texas
- USA Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2025-11-21 |
| Est. Completion | 2028-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07103018
The ClinicalTrials.gov registry entry for NCT07103018 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (27% lower). The listed sponsor is K36 Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which KTX-2001 is the first listed.
NCT07103018 reports 13 study locations spanning 9 distinct geographic areas - top geographies include New York, Florida, California.
Frequently Asked Questions
What is clinical trial NCT07103018 about?
NCT07103018 is a clinical study titled "A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)". 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 i...
What is the current status of trial NCT07103018?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2025-11-21. Estimated completion is 2028-09.
What conditions does trial NCT07103018 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer (mCRPC), mCRPC (Metastatic Castration-resistant Prostate Cancer), mCRPC, Metastatic Castration-Resistant Prostate Cancer Patients.
What interventions are being tested in trial NCT07103018?
The interventions under investigation include: KTX-2001 (DRUG), KTX-2001 + Darolutamide (NUBEQA®) (DRUG).
Who is sponsoring clinical trial NCT07103018?
This trial is sponsored by K36 Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07103018 being conducted?
This trial has 13 study locations across California, Florida, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.