A Phase 2 Multicenter Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

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A Phase 2 Multicenter Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

Brief description of study

This study will investigate the safety, tolerability of TYRA-300 and assess different doses of TYRA-300 in participants harboring FGFR3 mutations and/or fusions with intermediate risk NMIBC in order to identify the Phase 3 dose. Utilizing a Simons 2-Stage Design, a dosing cohort will be evaluated after approximately 15 participants have been enrolled with an expansion to 30 participants.

Clinical Study Identifier: s25-01269

ClinicalTrials.gov Identifier: NCT06995677

Principal Investigator: Katie S. Murray.

Other Investigators: Caitlin Elizabeth Ordonez Ferri, Tiffany M Tomberlin, Anam Qureshi, James S Wysock, Wei Phin Tan, Carol M Lee, Kenia J Rodriguez, Minas Platon Economides, Laura Catherine Bauer, Doris M Salazar, Victor Ricardo Adorno Febles, Jiping Zeng, Jonathan B Kahn, William C Huang, David R. Wise.

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Perlmutter Cancer Center

Clinical Trials & Research Studies