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A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)
Tyra Biosciences, Inc
This trial is investigating TYRA-300, a new FGFR3-selective tyrosine kinase inhibitor, in cancers with FGFR3 activating gene alterations including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid cancers. Phase 1 is a dose-escalation study, with two parts. In Part A (dose-escalation), participants will receive TYRA-300 (taken once daily by mouth in 28-day cycles) in increasing doses, starting at 10mg daily. In Part B (dose-expansion), participants will receive TYRA-300 (orally, once daily in 28-day cycles) to continue to study the safety and effect at certain doses. In Phase 2, participants will receive TYRA-3000 (orally, once daily in 28-day cycles) at the recommended doses determined during Phase 1.