New hope for tough prostate cancer? early trial launches

NCT ID NCT07103018

Recruiting now Disease control Sponsor: K36 Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called KTX-2001, alone or with another drug (darolutamide), in men with metastatic castration-resistant prostate cancer that has spread and stopped responding to hormone therapy. The main goals are to check safety, find the right dose, and see if the drug works. About 144 men will take part.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: KTX-2001 (an NSD2 inhibitor) and darolutamide
What this could lead to: If successful, this could point toward a new treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong: This is a very early Phase 1 trial with only 144 participants, so safety and dosing are still being figured out. The drug may not shrink tumors or improve survival, and side effects are unknown.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma Male Urogenital Diseases metastatic prostate carcinoma neoplasm Neoplasm Metastasis Neoplasms by Site prostate cancer prostate disorder Urogenital Diseases Urogenital Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MCRPC MCRPC (METASTATIC CASTRATION-RESISTANT PROSTATE CANCER) METASTATIC CASTRATION-RESISTANT PROSTATE CANCER METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) METASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS

Contacts and locations

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Locations

Carolina Urologic Research Center, the START Center for Cancer Research
RECRUITING

Myrtle Beach, South Carolina, 29572, United States
Columbia University Irving Medical Center
RECRUITING

New York, New York, 10032, United States

Contact Email: •••••@•••••
Duke Cancer Center
RECRUITING

Durham, North Carolina, 27710, United States
Hematology Oncology Associates of the Treasure Coast
RECRUITING

Port Saint Lucie, Florida, 34952, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10032, United States
NYU Langone Health
RECRUITING

New York, New York, 10016, United States
START New York Long Island, LLC
RECRUITING

New Hyde Park, New York, 11042, United States
Sylvester Comprehensive Cancer Center
RECRUITING

Miami, Florida, 33136, United States
The Ohio State University Comprehensive Cancer Center
NOT_YET_RECRUITING

Columbus, Ohio, 43210, United States
USA Clinical Trials
RECRUITING

San Antonio, Texas, 78229, United States
University of California San Francisco
RECRUITING

San Francisco, California, 94158, United States

Contact Email: •••••@•••••
University of Wisconsin
RECRUITING

Madison, Wisconsin, 53705, United States

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