๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-12

A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors (NCT04396821)

A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.

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

This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic cancers.

Who can join: Review the eligibility criteria below.

Location: Banner MD Anderson โ€” Gilbert, Arizona

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 (18 Sites)

  • Banner MD Anderson โ€” Gilbert, Arizona
  • University of Arizona โ€” Tucson, Arizona
  • Yale University โ€” New Haven, Connecticut
  • Florida Cancer Specialists โ€” Sarasota, Florida
  • Emory University โ€” Atlanta, Georgia
  • University of Kansas, School of Medicine โ€” Kansas City, Kansas
  • Washington University โ€” St Louis, Missouri
  • Memorial Sloan Kettering โ€” New York, New York
  • Stony Brook Cancer Center โ€” Stony Brook, New York
  • Wake Forest Baptist Comprehensive Cancer Center โ€” Winston-Salem, North Carolina
  • Gabrail Cancer Research โ€” Canton, Ohio
  • Pennsylvania Cancer Specialist Research Institute โ€” Gettysburg, Pennsylvania
  • Allegheny Hospital โ€” Pittsburgh, Pennsylvania
  • Sarah Cannon Research Institute โ€” Nashville, Tennessee
  • Vanderbilt University โ€” Nashville, Tennessee
  • NEXT Oncology โ€” Austin, Texas
  • Swedish Cancer Institute โ€” Seattle, Washington
  • Medical College of Wisconsin โ€” Milwaukee, Wisconsin

๐Ÿ“ž Contact the Study Coordinator

Phone: (877) 632-6789

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 Advanced Cancer 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†—