๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-08

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001) (NCT07103018)

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

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: K36 Therapeutics, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of California San Francisco โ€” San Francisco, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (13 Sites)

  • University of California San Francisco โ€” San Francisco, California
  • Sylvester Comprehensive Cancer Center โ€” Miami, Florida
  • Hematology Oncology Associates of the Treasure Coast โ€” Port Saint Lucie, Florida
  • Mayo Clinic โ€” Rochester, Minnesota
  • START New York Long Island, LLC โ€” New Hyde Park, New York
  • NYU Langone Health โ€” New York, New York
  • Columbia University Irving Medical Center โ€” New York, New York
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Duke Cancer Center โ€” Durham, North Carolina
  • The Ohio State University Comprehensive Cancer Center โ€” Columbus, Ohio
  • Carolina Urologic Research Center, the START Center for Cancer Research โ€” Myrtle Beach, South Carolina
  • USA Clinical Trials โ€” San Antonio, Texas
  • University of Wisconsin โ€” Madison, Wisconsin

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 347-5787

Email: strike-001@k36tx.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—