RecruitingPhase 2NCT07265947
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)
Sponsor
Tyra Biosciences, Inc
Enrollment
230 participants
Start Date
Dec 22, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
Eligibility
Min Age: 18 Years
Inclusion Criteria17
- Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures
- Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA
- At least 5mm of marker lesion left behind
- Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing
- 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 0-2
- Pathology consists of pure urothelial carcinoma
- Adequate bone marrow, liver, and renal function:
- i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL
- i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN
- Estimated glomerular filtration rate >60 mL/min
- Serum Phosphate level ≤ ULN prior to starting treatment
- International normalized ratio (INR) ≤1.5 × ULN
Exclusion Criteria14
- 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 randomization
- Treatment with an investigational agent within 30 days or 5 half-lives from randomization, 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 potential inhibitors or inducers of CYP3A (prohibited list of medications)
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Interventions
DRUGDabogratinib (TYRA-300) 60mg
Self-administered 60mg dose Oral tablet(s) given daily
DRUGDabogratinib (TYRA-300) 80mg
Self-administered 80mg dose Oral tablet(s) given daily
DRUGDabogratinib (TYRA-300) TBD
To be determined: Self-administered Oral tablet(s) given daily
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07265947