OncoMatch/Clinical Trials/NCT06774131
A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
Is NCT06774131 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies UGN-104 for upper urinary tract urothelial carcinoma.
Treatment: UGN-104 — This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \[mitomycin\] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Grade: low-grade
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: Bacillus Calmette-Guérin
Patient received Bacillus Calmette-Guérin (BCG) treatment for UC during the 6 months before enrollment
Cannot have received: JELMYTO (UGN-101)
Patient was previously treated with JELMYTO (product code UGN-101) for UTUC
Lab requirements
Blood counts
Leukocytes ≥ 3,000/μL; ANC ≥ 1,500/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 9.0 g/dL
Kidney function
eGFR ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN
Patients must have adequate organ and bone marrow function as determined by the following routine laboratory tests: Leukocytes ≥ 3,000/μL; ANC ≥ 1,500/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 9.0 g/dL; Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; eGFR ≥ 30 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Urology Centers of Alabama · Homewood, Alabama
- Arizona State Urological Research Institute, LLC ("ASURI") · Chandler, Arizona
- Michael G Oefelein Clinical Trials · Bakersfield, California
- University of California, Irvine · Orange, California
- BioResearch Partners Aventura · Aventura, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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