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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06774131
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 70 participants
Conditions and interventions
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
- Sep 2, 2026
2025 – 2028
United States locations
- U.S. sites
- 34
- U.S. states
- 17
- U.S. cities
- 33
| 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 |
| East Valley Urology Center of Arizona | Queen Creek | Arizona | 85140 | Recruiting |
| University of Arkansas for Medical Sciences | Arkansas City | Arkansas | 72205 | Recruiting |
| Michael G Oefelein Clinical Trials | Bakersfield | California | 93301 | Recruiting |
| UC Irvine Health. Chao Family Comprehensive Cancer Center | Orange | California | 92868 | Recruiting |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Recruiting |
| Bioresearch Partner - Aventura | Aventura | Florida | 33180 | Recruiting |
| University of Florida Health (UF Health), Cancer Center | Gainesville | Florida | 32610 | Recruiting |
| Bioresearch Partner - Hialeah Hospital | 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 | Completed |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | Recruiting |
| University of Rochester Medical Center | Rochester | New York | 14642 | Not yet recruiting |
| Montefiore Medical Center - Bronx | The Bronx | New York | 10461 | Recruiting |
| Urology Specialists of the Carolinas, PLLC | Charlotte | North Carolina | 28204 | Recruiting |
| Urology Specialists of the Carolinas - Greensboro | Greensboro | North Carolina | 27403 | 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 | Completed |
| UPNT Research Institute, LLC | Arlington | Texas | 76017 | Recruiting |
| Texas Urology Specialists-Austin | Austin | Texas | 78705 | Recruiting |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Completed |
| Houston Metro Urology (HMU) - Southwest Location | Houston | Texas | 77027 | Recruiting |
| Lumi Research - Houston | Houston | Texas | 77090 | Recruiting |
| USA Operation d/b/a US Clinical Trials | San Antonio | Texas | 78229 | Recruiting |
| Renovatio Clinical - The Woodlands Research Center | The Woodlands | Texas | 77380 | 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 45 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 Sep 2, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06774131 live on ClinicalTrials.gov.