Dabogratinib for Low Grade Cancer of the Upper Urinary Tract Lining
Tests dabogratinib in adults with low grade upper tract urothelial carcinoma.
Plain-language title generated from the registry record
Registry title: Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
Key facts
- Where
- Albany, Ann Arbor, Atlanta, Austin, Chicago, Cleveland, Columbus, Dallas, Gahanna, Greenwood, Houston, Indianapolis, Jeffersonville, Lisle, Loma Linda, Los Angeles, Mt. Pleasant, Nashville, Plymouth, Radnor, Royal Oak, Sewell, St Louis, Syracuse, and Tampa, United StatesSee the 25 sites
- Phase
- Phase 2
Where in United States
- Albany Medical CollegeAlbany, United StatesTaking people
- University of Michigan Health System (UMHS)Ann Arbor, United StatesTaking people
- The Winship Cancer Institute of Emory UniversityAtlanta, United StatesTaking people
- Urology Austin - Apex Cancer Care - AustinAustin, United StatesTaking people
- The University Of ChicagoChicago, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- The Ohio State University -Wexner Medical CenterColumbus, United StatesTaking people
- The University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- Central Ohio Urology GroupGahanna, United StatesTaking people
- Urology of Indiana, LLCGreenwood, United StatesTaking people
- The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
- Indiana University (IU) Health Physicians - UrologyIndianapolis, United StatesTaking people
- First UrologyJeffersonville, United StatesTaking people
- Duly Health and Care ChicagoLisle, United StatesTaking people
- Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM)Loma Linda, United StatesTaking people
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesTaking people
- Medical University of South Carolina (MUSC)Mt. Pleasant, United StatesTaking people
- Urology Associates, P.C.Nashville, United StatesTaking people
- Greater Boston Urology - Plymouth Care CenterPlymouth, United StatesTaking people
- Penn Medicine RadnorRadnor, United StatesTaking people
- Michigan Healthcare Professionals - William Beaumont University HospitalRoyal Oak, United StatesTaking people
- Summit Health - Washington TownshipSewell, United StatesTaking people
- Urology of St. LouisSt Louis, United StatesTaking people
- Associated Medical Professionals of NY, PLLCSyracuse, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tyra Biosciences, Inc
- Trial code
- NCT07265947EU 2025-523539-20-00
- Record updated
- 2 November 2026
- Original description
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial CarcinomaRead full original descriptionShow less
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)
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
Exclusion: Current or previous history of muscle invasive bladder cancer; Current or previous history of lymph node positive and/or metastatic bladder cancer; Currently receiving systemic cancer therapy (cytotoxic or immunotherapy); Current or prior history of pelvic external beam radiotherapy for bladder cancer; Current or history of receiving a prior FGFR inhibitor; Systemic immunotherapy within 6 months prior to C1D1; Treatment with an investigational agent within 30 days or 5 half-lives from C1D1, whichever is shorter; compounds with an unknown half-life will be default to 30 days; Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D1; Requiring use of medications that are strong and moderate inhibitors or inducers of CYP3A or inhibitors of P-gp and BCRP transporters (prohibited list of medications); History of carcinoma in situ (CIS); History of prostatic urethral involvement; Evidence or any features of high grade (HG) UTUC; Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder; Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.
Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures; Confirmed LG UTUC (both favorable and unfavorable) per AUA; At least 5mm of marker lesion(s) left behind; Identification of marker lesion(s) within 8 weeks prior to randomization (refer to Inclusion Criterion #2); If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T1; No prior BCG administration within 1 year of date of consent; No intravesical chemotherapy within 8 weeks prior to C1D1 (including UGN-101); No systemic chemotherapy within 3 months prior to C1D1; ECOG PS 0-2; Pathology consists of pure urothelial carcinoma; Adequate bone marrow function:; Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL; Adequate liver function:; Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN; Adequate renal function:; Estimated glomerular filtration rate >30 mL/min ii. Serum Phosphate level ≤ ULN prior to starting treatment iii. International normalized ratio (INR) ≤1.5 × ULN.