RecruitingPhase 1NCT07103018

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

Phase 1, Dose-Escalation Study of KTX2001 (an NSD2 Inhibitor) Alone and in Combination With Darolutamide for Metastatic Castration-Resistant Prostate Cancer

Sponsor

K36 Therapeutics, Inc.

Enrollment

144 participants

Start Date

Nov 21, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer Metastatic Castration-Resistant Prostate Cancer Patients

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called KTX-2001 in men with advanced prostate cancer that has stopped responding to hormone therapy (called castration-resistant prostate cancer that has spread to other parts of the body). **You may be eligible if...** - You are 18 or older and male - You have metastatic prostate cancer that has continued to grow despite hormone therapy - Your cancer spread is confirmed by bone scan, CT, or MRI - Your overall health is good (ECOG 0 or 1) - You are willing to undergo tumor biopsies as part of the study **You may NOT be eligible if...** - Your cancer is not confirmed as castration-resistant or not metastatic - You have serious heart, liver, or other organ problems - You have had certain prior treatments that would affect eligibility Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKTX-2001

Participants will receive escalating doses of KTX-2001 monotherapy

DRUGKTX-2001 + Darolutamide (NUBEQA®)

Participants will receive escalating doses of KTX-2001, in combination with the oral androgen receptor (AR) pathway inhibitor (ARPI), darolutamide (NUBEQA®)

Locations(13)

University of California San Francisco

San Francisco, California, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

START New York Long Island, LLC

New Hyde Park, New York, United States

NYU Langone Health

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke Cancer Center

Durham, North Carolina, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Carolina Urologic Research Center, the START Center for Cancer Research

Myrtle Beach, South Carolina, United States

USA Clinical Trials

San Antonio, Texas, United States

University of Wisconsin

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07103018

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