๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-08

Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations (NCT05544552)

A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Tyra Biosciences, Inc

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

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.

Who can join: Review the eligibility criteria below.

Location: Dana Farber Cancer Institute โ€” Boston, Massachusetts

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 (19 Sites)

  • Dana Farber Cancer Institute โ€” Boston, Massachusetts
  • UMass Memorial Medical Center โ€” Worchester, Massachusetts
  • Memorial Sloan Kettering Cancer Center (MSKCC) โ€” New York, New York
  • Duke Cancer Institute (DCI) - Duke Cancer Center โ€” Durham, North Carolina
  • Cleveland Clinic - Main Campus โ€” Cleveland, Ohio
  • Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville โ€” Nashville, Tennessee
  • Seattle Cancer Care Alliance (SCCA) - South Lake Union โ€” Seattle, Washington
  • Macquarie University โ€” Macquarie Park, New South Wales
  • Tasman Oncology โ€” Southport, Queensland
  • Princess Alexandra Hospital โ€” Woolloongabba, Queensland
  • Austin Health โ€” Heidelberg, Victoria
  • Peter MacCallum Cancer Research Unit โ€” Melbourne, Victoria
  • Linear Clinical Research Limited โ€” Nedlands, Washington
  • Institut de Cancerologie de L'Ouest (ICO) โ€” Saint-Herblain,
  • Institut Claudius Regaud, IUCT-Oncopole โ€” Toulouse,
  • Gustave Roussy (Institut de Cancerologie Gustave-Roussy) โ€” Villejuif,
  • NEXT Barcelona - Hospital Quironsalud Barcelona โ€” Barcelona,
  • Vall d'Hebron Institut d'Oncologia (VHIO) โ€” Barcelona,
  • NEXT Madrid - Hospital Universitario Quironsalud Madrid โ€” Madrid,

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. Review the official NIH record below to find the coordinating site.
  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†—