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

This clinical trial is studying an experimental drug called TYRA-300 for people with non-muscle invasive bladder cancer (NMIBC). The study focuses on individuals whose cancer is "intermediate risk," meaning it has a higher chance of coming back but has not reached the bladder muscle. Researchers are testing how well TYRA-300 works against tumors that have a specific genetic change, known as an FGFR3 mutation or fusion. TYRA-300 is a targeted therapy designed to block the signals these mutated cells use to grow.

To be eligible, you must have a confirmed diagnosis of low-grade NMIBC and a documented FGFR3 genetic alteration. This study is for patients who have at least one small tumor left in the bladder that your doctor can see and monitor, often called a "marker lesion." You should not have received BCG treatment within the last year or chemotherapy delivered directly into the bladder within the last two eight weeks. Because TYRA-300 is a pill taken once a day by mouth, you must be able to swallow tablets. You must also have generally healthy organ function and no history of certain eye or heart conditions.

Participation involves taking the study drug daily and attending regular clinic visits for monitoring. Before enrolling, you should talk with your doctor about your specific bladder cancer history, any genetic testing you have had on your tumor, and how this oral treatment compares to standard treatments like surgery or bladder washes. Your doctor can also explain how this drug might interact with other medications you take.