๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-10

A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors (NCT06797336)

A Phase 1, Open-Label Dose Escalation and Expansion Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors

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

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

The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0253 in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutated advanced solid tumors as monotherapy.

Who can join: Review the eligibility criteria below.

Location: START Los Angeles โ€” Los Angeles, California

Age range: 18 Years

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 (15 Sites)

  • START Los Angeles โ€” Los Angeles, California
  • Dana Farber/Massachusetts General Hospital, Inc โ€” Boston, Massachusetts
  • START Midwest โ€” Grand Rapids, Michigan
  • SCRI Lake Mary โ€” Nashville, Tennessee
  • SCRI Oncology Partners โ€” Nashville, Tennessee
  • New Experimental Therapeutics of San Antonio LLC โ€” San Antonio, Texas
  • START - South Texas Accelerated Research Therapeutics, LLC โ€” San Antonio, Texas
  • START Mountain Region โ€” West Valley City, Utah
  • NEXT Virginia โ€” Fairfax, Virginia
  • CHA University Bundang Medical Center โ€” Seongnam,
  • Asan Medical Center โ€” Seoul,
  • Samsung Medical Center โ€” Seoul,
  • Seoul National University Bundang Hospital โ€” Seoul,
  • Seoul National University Hospital โ€” Seoul,
  • Severance Hospital, Yonsei University Health System โ€” Seoul,

๐Ÿ“ž Contact the Study Coordinator

Phone: (781) 819-2949

Email: ClinicalTrials@paqtx.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.

Explore by condition: All Solid Tumor clinical trials

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†—