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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with low grade cancer of the upper urinary tract (kidney or ureter lining) who still have a visible tumour left behind.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Confirmed low grade upper tract urothelial carcinoma, with at least 5mm of marker lesion(s) left behind. Pure urothelial carcinoma. Any bladder tumour present must be fully removed and low-grade Ta or T1.
- Earlier treatment
- No BCG within 1 year. No chemotherapy into the bladder within 8 weeks. No chemotherapy through the body within 3 months. No earlier FGFR inhibitor.
Main reasons for not taking part
- Any sign of high grade upper tract cancer
- History of carcinoma in situ or muscle invasive bladder cancer
- Cancer that has spread to lymph nodes or other organs
- Past or present central serous retinopathy or retinal pigmented epithelial detachment
- Needing strong or moderate CYP3A inhibitors or inducers, or P-gp and BCRP inhibitors
Read by machine on 12 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.