A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
Public ClinicalTrials.gov record NCT06774131. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)
Study identification
- NCT ID
- NCT06774131
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- UroGen Pharma Ltd.
- Industry
- Enrollment
- 70 participants
Conditions and interventions
Interventions
- UGN-104 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 5, 2025
- Primary completion
- Feb 28, 2027
- Completion
- Feb 29, 2028
- Last update posted
- Apr 28, 2026
2025 – 2028
United States locations
- U.S. sites
- 23
- U.S. states
- 13
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | 35209 | Recruiting |
| Arizona State Urological Research Institute, LLC ("ASURI") | Chandler | Arizona | 85225 | Recruiting |
| 1155 E. Combs Rd, Suite 105, Queen Creek, AZ, 85140, USA | Queen Creek | Arizona | 85140 | Recruiting |
| Michael G Oefelein Clinical Trials | Bakersfield | California | 93301 | Recruiting |
| University of California, Irvine | Orange | California | 92868 | Recruiting |
| BioResearch Partners Aventura | Aventura | Florida | 33180 | Recruiting |
| UF Health Cancer Center University of Florida | Gainesville | Florida | 32610 | Recruiting |
| BioResearch Partners Hialeah | Hialeah | Florida | 33013 | Recruiting |
| D&H National Research Centers - Cancer Research Center, LLC | Margate | Florida | 33063 | Recruiting |
| Urology Center of Iowa Research | Clive | Iowa | 50325 | Recruiting |
| The Urology Center, P.C. | Omaha | Nebraska | 68114 | Recruiting |
| Montefiore Medical Center - Bronx | The Bronx | New York | 10461 | Recruiting |
| University of Cincinnati Medical Center (UCMC) | Cincinnati | Ohio | 45219 | Recruiting |
| The James Cancer Hospital and Solove Research Institute | Columbus | Ohio | 43210 | Recruiting |
| Urologic Specialists of Oklahoma | Tulsa | Oklahoma | 74146-5830 | Recruiting |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| Carolina Urologic Research Center, LLC | Myrtle Beach | South Carolina | 29572 | Recruiting |
| Low county Urology Clinics | North Charleston | South Carolina | 29406 | Recruiting |
| Amarillo Urology Research | Amarillo | Texas | 79106 | Recruiting |
| UPNT Research Institute, LLC | Arlington | Texas | 76017 | Recruiting |
| Texas Urology Specialists-Austin | Austin | Texas | 78705 | Recruiting |
| University of Virginia Comprehensive Cancer Center | Charlottesville | Virginia | 22908 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06774131, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2026 · Synced May 16, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06774131 live on ClinicalTrials.gov.