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

Required: FGFR3 activating mutation

Required: FGFR3 fusion

Cannot have received: BCG

Exception: BCG within 1 year of date of consent

No prior BCG administration within 1 year of date of consent.

Cannot have received: intravesical chemotherapy

Exception: within 8 weeks prior to C1D1

No intravesical chemotherapy within 8 weeks prior to C1D1.

Cannot have received: FGFR inhibitor

Current or history of receiving a prior FGFR inhibitor

Cannot have received: systemic immunotherapy

Exception: within 6 months prior to randomization

Systemic immunotherapy within 6 months prior to randomization

Cannot have received: systemic cancer therapy

Currently receiving systemic cancer therapy (cytotoxic, immunotherapy, targeted)

Cannot have received: pelvic external beam radiotherapy

Current or prior history of pelvic external beam radiotherapy

Cannot have received: investigational agent

Exception: within 30 days or 5 half-lives from randomization, whichever is shorter

Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter

Cannot have received: intravesical agent

Exception: within 8 weeks prior to C1D1

Prior treatment with an intravesical agent within 8 weeks prior to C1D1