> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-2a-b-efficacy-and-safety-of-dabogratinib-in-f6e3d3f2-2408-4f18-858b-be1508ad9837 > Record changed: 2026-11-04 # Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma NCT07265947 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) Participants 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) Lead sponsor Tyra Biosciences, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) Start date 2025-12-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) Number of sites 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## Title and summary **Summary** A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Acronym** SURF303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Short title** Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Official title** 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](https://clinicaltrials.gov/study/NCT07265947) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## Dates **Completion date** 2030-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **First posted** 2025-12-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Registry last updated** 2026-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Primary completion date** 2030-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Start date** 2025-12-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## Size and sites **Participants** 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Planned participants** 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Number of sites** 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Lead sponsor** Tyra Biosciences, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## Identifiers **Registry ID** NCT07265947 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **ClinicalTrials.gov ID** NCT07265947 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## Outcomes ### Primary outcomes 1. To assess the efficacy of Dabogratinib in LG UTUC FGFR3+ participants (proportion of participants with a CR within 6 months out of all LG UTUC FGFR3+ participants) Timeframe: within 6 months Complete response (CR) rate ### Secondary outcomes 1. To assess the efficacy of Dabogratinib in LG UTUC in all participants (proportion of participants with a CR within 6 months out of all LG UTUC participants) Timeframe: at 6 months Complete Response (CR) rate 2. Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR) Timeframe: up to 36 months 3. Complete Response (proportion of participants who continue to have a CR at 12 and 24 months) Timeframe: at 12 and 24 months 4. Safety and tolerability of dabogratinib Timeframe: Up to 2 years Incidence rate and severity of adverse events 5. Rate of renal preservation after treatment with dabogratinib Timeframe: Up to 2 years Proportion of participants who did not undergo a nephrectomy or nephroureterectomy 6. Change from unresectable UTUC to resectable UTUC Timeframe: Up to 2 years Proportion of participants with unresectable disease at baseline who convert to resectable disease on dabogratinib, as assessed by the Investigator Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No - 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: i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL - Adequate liver function: i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN - Adequate renal function: i. Estimated glomerular filtration rate >30 mL/min ii. Serum Phosphate level ≤ ULN prior to starting treatment iii. International normalized ratio (INR) ≤1.5 × ULN ### Exclusion criteria - Evidence or any features of high grade (HG) UTUC - History of carcinoma in situ (CIS) - History of prostatic urethral involvement - Current or previous history of muscle invasive bladder cancer - Current or previous history of lymph node positive and/or metastatic bladder cancer - Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder - 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. - Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination. - 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## Sites - Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM)Loma Linda, United StatesRecruiting - USC Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - The Winship Cancer Institute of Emory UniversityAtlanta, United StatesRecruiting - Duly Health and Care ChicagoLisle, United StatesRecruiting - Urology of Indiana, LLCGreenwood, United StatesRecruiting - Indiana University (IU) Health Physicians - UrologyIndianapolis, United StatesRecruiting - First UrologyJeffersonville, United StatesRecruiting - Greater Boston Urology - Plymouth Care CenterPlymouth, United StatesRecruiting - University of Michigan Health System (UMHS)Ann Arbor, United StatesRecruiting - Michigan Healthcare Professionals - William Beaumont University HospitalRoyal Oak, United StatesRecruiting - Urology of St. LouisSt Louis, United StatesRecruiting - Summit Health - Washington TownshipSewell, United StatesRecruiting - Albany Medical CollegeAlbany, United StatesRecruiting - Associated Medical Professionals of NY, PLLCSyracuse, United StatesRecruiting - Cleveland ClinicCleveland, United StatesRecruiting - Central Ohio Urology GroupGahanna, United StatesRecruiting - Penn Medicine RadnorRadnor, United StatesRecruiting - Medical University of South Carolina (MUSC)Mt. Pleasant, United StatesRecruiting - Urology Associates, P CNashville, United StatesRecruiting - Urology Austin - Apex Cancer Care - AustinAustin, United StatesRecruiting - The University of Texas Southwestern Medical CenterDallas, United StatesRecruiting - The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - Hopital Pitie-SalpetriereParis, FranceRecruiting - Hôpital Européen Georges Pompidou (HEGP)Paris, FranceRecruiting And 7 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## References ### Other registry identifiers (2) - 2025 - 2025-523539-20-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265947) ## Related records ### Drugs (1) - [Dabogratinib](https://trialight.com/data/asset/dabogratinib-01a09446-dcbc-5727-8197-e5622ce03f02.md) ### Lead sponsors (1) - [Tyra Biosciences, Inc](https://trialight.com/data/company/tyra-biosciences-inc-2588867c-c6ed-4b94-87e0-1884cabfc553.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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