Tyra Biosciences, Inc
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
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
Inclusion Criteria: * Participants age ≥18 at time of informed consent and willing and able to comply with all required study procedures * Able to understand and given written informed consent * Participants with histologically confirmed low-grade NMIBC within 8 weeks prior to C1D1 with prior diagnostic biopsy/TURBT to confirm stage and grade and with at least 3 mm and no more than 12 mm total (1/2 a resectoscope loop to 2 loops, refer to Section 8.1.6) residual visible tumor as a marker lesion(s) left behind: 1. Ta low grade 2. T1 low grade * Participants must have protocol-defined inte…
Self-administered 60mg dose Oral tablet(s) given daily
Self-administered 50mg dose Oral tablet(s) given daily
Self-administered 70 mg Oral tablet(s) given daily