NCT07265947 · Tyra Biosciences, Inc
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
(SURF303)
What this study is about
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
View original scientific description
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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 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 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)
Where
- Atlanta, Georgia
- Lisle, Illinois
- Greenwood, Indiana
- Jeffersonville, Indiana
- Plymouth, Massachusetts
- Sewell, New Jersey
- Albany, New York
- Syracuse, New York
- Cleveland, Ohio
- Gahanna, Ohio
- Nashville, Tennessee
- Austin, Texas
And 1 more location — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations