Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT07103018 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 144 participants
Start Date 2025-11-21
Est. Completion 2028-09
Phase Phase 1

Sponsor

K36 Therapeutics

2 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is K36 Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07103018 reports 13 study locations spanning 9 distinct geographic areas — top geographies include New York, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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, mCRPC (Metastatic Castration-resistant Prostate Cancer), mCRPC, Metastatic Castration-Resistant Prostate Cancer Patients, Metastatic Castration-resistant Prostate Cancer, mCRPC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07103018?

The interventions under investigation include: KTX-2001 (DRUG), KTX-2001 + Darolutamide (NUBEQA®) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07103018?

This trial is sponsored by K36 Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial