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
- Cadiz, Madrid, Santander, Sevilla, and Valencia, SpainSee the 5 sites
- Phase
- Phase 2
Where in Spain
- Hospital Universitario Puerta del MarCadiz, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- Hospital Universitario Virgen De La MacarenaSevilla, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking 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.