๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-12

A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation (NCT06778863)

GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

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

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

Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.

Who can join: Review the eligibility criteria below.

Location: HonorHealth Research Institute โ€” Scottsdale, Arizona

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 (21 Sites)

  • HonorHealth Research Institute โ€” Scottsdale, Arizona
  • The University of Arizona Cancer Center โ€” Tucson, Arizona
  • USC - Norris Comprehensive Cancer Center โ€” Los Angeles, California
  • University of California Davis Comprehensive Cancer Center โ€” Sacramento, California
  • University of California San Francisco โ€” San Francisco, California
  • University of Miami - Sylvester Comprehensive Cancer Center โ€” Miami, Florida
  • The University of Chicago Comprehensive Cancer Center โ€” Chicago, Illinois
  • University of Kentucky Markey Cancer Center โ€” Lexington, Kentucky
  • Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center โ€” Baltimore, Maryland
  • Hackensack University Medical Center โ€” Hackensack, New Jersey
  • NYU Langone Health โ€” New York, New York
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Duke Cancer Institute โ€” Durham, North Carolina
  • Thomas Jefferson University, Sidney Kimmel Cancer Center โ€” Philadelphia, Pennsylvania
  • Fox Chase Cancer Center โ€” Philadelphia, Pennsylvania
  • Sarah Cannon Research Institute (SCRI) Oncology Partners โ€” Nashville, Tennessee
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee
  • Mary Crowley Cancer Research โ€” Dallas, Texas
  • Baylor University Medical Center โ€” Dallas, Texas
  • MD Anderson Cancer Center โ€” Houston, Texas
  • Fred Hutchinson Cancer Center โ€” Seattle, Washington

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 812-1431

Email: LHarshman@clasptx.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†—