Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations

Study acronym: SURF431
StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Re-verified, no change to tracked fields
  2. Enrollment increased: 100 → 125 participants
    • Eligibility criteria shortened, about 33 words
    • Secondary endpoints: details revised at 4 of 12 entries
    • Site details revised at 1 of 16 sites
  3. Re-verified, no change to tracked fieldsv9
  4. Site contacts updated at 5 of 16 sitesv8
  5. Study sites: 15 to 16v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 13 to 15v6
  2. Study sites: 12 to 13v5
  3. Study sites: 5 to 12
    • Start date changed from estimate of Apr 2025 to Apr 24, 2025
    v4
  4. Study sites: 2 to 5v3
  5. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary antitumor activity of TYRA-430 in cancers with FGF/FGFR pathway aberrations, including locally advanced/metastatic hepatocellular carcinoma and other advanced solid tumors.
Trial Details
NCT Number NCT06915753
Lead Sponsor Tyra Biosciences, Inc
Conditions
(from sponsor)		 Metastatic Hepatocellular Carcinoma, Solid Tumors, Solid Tumor, Adult, FGFR Gene Amplification, FGFR Gene Alterations, Advanced Solid Tumors, FGFR4 Gene Mutation, FGFR4 Gene Fusions +3 more
Related terms Carcinoma, Hepatocellular, Neoplasm Metastasis
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov