Recruiting NCT07265947
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dabogratinib (TYRA-300) 60mg, Dabogratinib (TYRA-300) 80mg, Dabogratinib (TYRA-300) TBD.
- Who it may be relevant to
- Registry conditions: Low Grade Upper Tract Urothelial Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
Detailed description
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)
Interventions
- Drug Dabogratinib (TYRA-300) 60mg
Self-administered 60mg dose Oral tablet(s) given daily - Drug Dabogratinib (TYRA-300) 80mg
Self-administered 80mg dose Oral tablet(s) given daily - Drug Dabogratinib (TYRA-300) TBD
To be determined: Self-administered Oral tablet(s) given daily
Primary outcome measures
- 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) [Time frame: within 6 months]
Secondary outcome measures (6)
- 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) [Time frame: at 6 months]
- Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR) [Time frame: up to 36 months]
- Complete Response (proportion of participants who continue to have a CR at 12 and 24 months) [Time frame: at 12 and 24 months]
- Safety and tolerability of dabogratinib [Time frame: Up to 2 years]
- Rate of renal preservation after treatment with dabogratinib [Time frame: Up to 2 years]
- Change from unresectable UTUC to resectable UTUC [Time frame: Up to 2 years]
Eligibility criteria
- 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 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 16 centers
- Moffitt Cancer Center — Tampa
- The Winship Cancer Institute of Emory University — Atlanta
- Duly Health and Care Chicago — Lisle
- Urology of Indiana, LLC — Greenwood
- First Urology — Jeffersonville
- Greater Boston Urology - Plymouth Care Center — Plymouth
- Urology of St. Louis — St Louis
- Summit Health - Washington Township — Sewell
- … and 8 more centers
Spain · 1 center
- Hospital Universitario Puerta del Mar — Cadiz
Identifiers
NCT: NCT07265947 · TYR300-203 · 2025-523539-20-00