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 (SURF302)
Tyra Biosciences, Inc
Summary
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
Description
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants age 18 and over of informed consent and willing and able to comply with all requires study procedures * Able to understand and given written informed consent * Participants with histologically confirmed low-grade NMIBC within 6 weeks prior to randomization 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 8.1.5) residual visible tumor as a marker lesion(s) left behind: 1. Ta low grade 2. T1 low grade * Participants must have intermediate…
Interventions
- DrugTYRA-300 60mg
Self-administered 60mg dose Oral tablet(s) given daily
- DrugTYRA-300 50mg
Self-administered 50mg dose Oral tablet(s) given daily
- DrugTYRA-300 Dose TBD
To Be Determined Dose: Self-administered Oral tablet(s) given daily
Locations (37)
- Urology Centers of AlabamaHomewood, Alabama
- Arkansas UrologyLittle Rock, Arkansas
- Tri Valley Urology - MurrietaMurrieta, California
- Om Research LLCSan Diego, California
- Associated Urological SpecialistsChicago Ridge, Illinois
- Duly Health and CareLisle, Illinois