NCT07265947RecruitingPhase 2
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
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)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 285 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 22 Dec 2025
- Primary completion date
- Oct 2030
- Lead sponsor
- Tyra Biosciences, Inc
- Diseases
- Bladder cancer
- NCT number
- NCT07265947
- EU CT number
- 2025-523539-20-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 285
- From 22 Dec 2025 to the primary completion date, Oct 2030
- 42 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- History of carcinoma in situ (CIS)
- History of prostatic urethral involvement
Other
- 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.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (42)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Multiprofessional Hospital For Active Treatment Plovdiv AD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Alexandrovska University Hospital Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Hospital Universitario Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| CHU de Bordeaux, groupe hospitalier Pellegrin, Hopital des Enfants Coordinator of this site? Confirm its status | Bordeaux Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Recruiting |
| Edith Wolfson Medical Center Coordinator of this site? Confirm its status | Holon | Israel | Recruiting |
| Hadassah University Hospital - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Recruiting |
| Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Albany Medical College Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| University of Michigan Health System (UMHS) Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| The Winship Cancer Institute of Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Urology Austin - Apex Cancer Care - Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| The University Of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| The University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Central Ohio Urology Group Coordinator of this site? Confirm its status | Gahanna | United States | Recruiting |
| Urology of Indiana, LLC Coordinator of this site? Confirm its status | Greenwood | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Indiana University (IU) Health Physicians - Urology Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| First Urology Coordinator of this site? Confirm its status | Jeffersonville | United States | Recruiting |
| Duly Health and Care Chicago Coordinator of this site? Confirm its status | Lisle | United States | Recruiting |
| Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM) Coordinator of this site? Confirm its status | Loma Linda | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Medical University of South Carolina (MUSC) Coordinator of this site? Confirm its status | Mt. Pleasant | United States | Recruiting |
| Urology Associates, P.C. Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Greater Boston Urology - Plymouth Care Center Coordinator of this site? Confirm its status | Plymouth | United States | Recruiting |
| Penn Medicine Radnor Coordinator of this site? Confirm its status | Radnor | United States | Recruiting |
| Michigan Healthcare Professionals - William Beaumont University Hospital Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
| Summit Health - Washington Township Coordinator of this site? Confirm its status | Sewell | United States | Recruiting |
| Urology of St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Associated Medical Professionals of NY, PLLC Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.