A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants With Low Grade Upper Tract Urothelial Carcinoma (SURF303)
Tyra Biosciences, Inc
Summary
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
Description
A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
1. Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures 2. Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA 3. At least 5mm of marker lesion left behind 4. Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing 5. Identification of marker lesion(s) within 8 weeks prior to randomization (refer to Inclusion Criterion #2) 6. If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T1 7. No prior BCG administrati…
Interventions
- DrugDabogratinib (TYRA-300) 60mg
Self-administered 60mg dose Oral tablet(s) given daily
- DrugDabogratinib (TYRA-300) 80mg
Self-administered 80mg dose Oral tablet(s) given daily
- DrugDabogratinib (TYRA-300) TBD
To be determined: Self-administered Oral tablet(s) given daily
Locations (4)
- Duly Health and Care ChicagoLisle, Illinois
- First UrologyJeffersonville, Indiana
- Cleveland ClinicCleveland, Ohio
- Urology Associates, P CNashville, Tennessee