Clinical Trial

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

Study acronym: SURF301
Active, Not Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2022-09-15; most recent amendment 2026-01-08.
Status change: Recruiting → Active, Not Recruiting 2026-01-08
Status change: Not Yet Recruiting → Recruiting 2022-10-05
Trial Details
NCT Number NCT05544552
Lead Sponsor Tyra Biosciences, Inc
Conditions Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Solid Tumor, Urothelial Carcinoma, Solid Tumor, Adult, Bladder Cancer, Non-muscle-invasive Bladder Cancer, FGFR3 Gene Mutation +6 more
Enrollment 310 participants
Start Date 2022-11-22
Primary Completion 2026-11 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-12