New hope for tough prostate cancer? early trial launches

NCT ID NCT07103018

First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 35 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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for METASTATIC CASTRATION RESISTANT PROSTATE CANCER are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

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

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

    Contact

  • Hematology Oncology Associates of the Treasure Coast

    RECRUITING

    Port Saint Lucie, Florida, 34952, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Mayo Clinic

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Phone: •••-•••-••••

    Contact

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10032, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

    Contact

  • START New York Long Island, LLC

    RECRUITING

    New Hyde Park, New York, 11042, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • The Ohio State University Comprehensive Cancer Center

    NOT_YET_RECRUITING

    Columbus, Ohio, 43210, United States

    Contact

  • USA Clinical Trials

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

    Contact Email: •••••@•••••

    Contact

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53705, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

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.

Conditions

The condition(s) this trial relates to.

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.