A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
NCT06774131
This study is recruiting at 30 US sites in 16 states, according to its ClinicalTrials.gov record last updated .
Summary
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Upper Urinary Tract Urothelial Carcinoma
- Urothelial Carcinoma
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- UroGen Pharma Ltd.
- Last updated on ClinicalTrials.gov
- September 3, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- Urology Centers of Alabama · Homewood, AL
Arizona · 2
- Arizona State Urological Research Institute, LLC ("ASURI") · Chandler, AZ
- East Valley Urology Center of Arizona · Queen Creek, AZ
Arkansas · 1
- University of Arkansas for Medical Sciences · Arkansas City, AR
California · 2
- Michael G Oefelein Clinical Trials · Bakersfield, CA
- UC Irvine Health. Chao Family Comprehensive Cancer Center · Orange, CA
District of Columbia · 1
- Medstar Washington Hospital Center · Washington D.C., DC
Florida · 4
- Bioresearch Partner - Aventura · Aventura, FL
- University of Florida Health (UF Health), Cancer Center · Gainesville, FL
- Bioresearch Partner - Hialeah Hospital · Hialeah, FL
- D&H National Research Centers - Cancer Research Center, LLC · Margate, FL
Iowa · 1
- Urology Center of Iowa Research · Clive, IA
New Jersey · 1
- Rutgers Cancer Institute of New Jersey · New Brunswick, NJ
New York · 1
- Montefiore Medical Center - Bronx · The Bronx, NY
North Carolina · 2
- Urology Specialists of the Carolinas, PLLC · Charlotte, NC
- Urology Specialists of the Carolinas - Greensboro · Greensboro, NC
Ohio · 2
- University of Cincinnati Medical Center (UCMC) · Cincinnati, OH
- The James Cancer Hospital and Solove Research Institute · Columbus, OH
Oklahoma · 1
- Urologic Specialists of Oklahoma · Tulsa, OK
Pennsylvania · 1
- Penn State Milton S Hershey Medical Center · Hershey, PA
South Carolina · 3
- Medical University of South Carolina · Charleston, SC
- Carolina Urologic Research Center, LLC · Myrtle Beach, SC
- Low county Urology Clinics · North Charleston, SC
Texas · 6
- UPNT Research Institute, LLC · Arlington, TX
- Texas Urology Specialists-Austin · Austin, TX
- Houston Metro Urology (HMU) - Southwest Location · Houston, TX
- Lumi Research - Houston · Houston, TX
- USA Operation d/b/a US Clinical Trials · San Antonio, TX
- Renovatio Clinical - The Woodlands Research Center · The Woodlands, TX
Virginia · 1
- University of Virginia Comprehensive Cancer Center · Charlottesville, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.