Actively Recruiting
Study of Dabogratinib TYRA-300 in Treating Low Grade Upper Tract Urothelial Carcinoma Evaluating Different Dose Levels and Safety
Led by Tyra Biosciences, Inc · Updated on 2026-08-03
230
Participants Needed
17
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Dabogratinib TYRA-300 in people with low grade upper tract urothelial carcinoma, a type of cancer affecting the urinary tract. This Phase 2AB open-label study focuses on patients with FGFR3-positive tumors and aims to understand how well the drug works in reducing tumor presence within six months. Participants will receive daily oral doses of Dabogratinib at different strengths60mg, 80mg, or a dose to be determined. The study is randomized and involves multiple centers, with participants assigned to one of three dose groups to assess the drugs impact and safety. During the trial, participants will be monitored for response to treatment, including complete tumor response within six months and duration of response up to 36 months. Safety and kidney function will be observed for up to two years, alongside other measures like tumor resectability and renal preservation. The total participation duration spans until the studys completion in November 2030.
CONDITIONS
Brief Title
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
Research Team
M
Megan Henry
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