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)
Condition: Low Grade Upper Tract Urothelial Carcinoma
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT07265947
Sponsor: Tyra Biosciences, Inc
Phase: Phase 2
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: All
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 C1D
- 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)
View trial on ClinicalTrials.gov