RecruitingPhase 2

Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma

United States230 participantsStarted 2025-12-22

Plain-language summary

A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓0. ECOG 0-2
✓1. Pathology consists of pure urothelial carcinoma
✓2. 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

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

What they're measuring

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)

Timeframe: within 6 months

Trial details

NCT IDNCT07265947

SponsorTyra Biosciences, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-10

Contact for this trial

Grace Indyk

858-356-2323 TyraClinicalTrials@tyra.bio

View on ClinicalTrials.gov More Low Grade Upper Tract Urothelial Carcinoma trials