Phase 2 Study of TYRA-300 Oral Treatment for Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer with FGFR3 Alteration

What this Trial Is About

The trial investigates the efficacy and safety of TYRA-300 in adults with FGFR3 altered low-grade, intermediate-risk non-muscle invasive bladder cancer NMIBC. This Phase 2, multicenter, open-label study focuses on participants with specific tumor characteristics confirmed by diagnostic biopsy and who meet intermediate risk criteria according to updated guidelines. The study is designed to evaluate a new oral treatment option for this condition, providing important insights into its potential role in managing this cancer type. Participants receive TYRA-300 as a self-administered oral tablet daily in one of several dose groups 60 mg, 50 mg, or a dose to be determined. The study is randomized and open-label, with participants assigned to different dose cohorts to assess treatment effects. The treatment period and dose details are structured to monitor safety and response over time, allowing evaluation of how well the drug works in this patient group. Throughout the study, participants are monitored for efficacy and safety outcomes, including disease response at 3 months, duration and timing of any recurrence, recurrence-free survival at 12 and 24 months, and progression-free survival. Safety is assessed through adverse event monitoring up to 2 years. Participants undergo various clinical evaluations, including tumor assessments and laboratory tests, to track treatment effects and health status. The total study duration extends to September 2028, with ongoing follow-up to capture long-term outcomes and tolerability.

Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer