Study of UGN-104 for Low-Grade Upper Tract Urothelial Cancer
This study is testing UGN-104, a new gel-based form of the medicine mitomycin, for people with low-grade upper tract urothelial cancer (LG-UTUC). UGN-104 is put directly into the upper urinary tract. The study aims to see how well UGN-104 works and if it's safe. You might be able to join if you are 18 or older, have LG-UTUC in your kidney or the tube connecting it to your bladder, and have at least one measurable tumor 15mm or smaller. The main goal is to see how many people have a complete response (no detectable cancer) after about 3 months. This study plans to include 70 participants.
- Study design
- This is a single-arm study, meaning all participants receive UGN-104. It is designed to enroll 70 participants.
- What's involved
- You will receive UGN-104 once a week for 6 weeks. If your cancer responds completely, you may receive monthly maintenance treatments for 11 months and will have clinic visits every 3 months for 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- If you have a complete response, you will be followed for 12 months after that response is determined, or until your disease returns, gets worse, or you pass away.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
At a glance
Conditions
NCT06774131
Where you'd take part
This study runs at 79 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
"Dr. Carol Davila" Nephrology Clinical Hospital Bucharest
Bucharest, Bucharest, Romaniastudy coordinator listed
Recruiting
Arizona State Urological Research Institute, LLC ("ASURI")
Chandler, Arizonastudy coordinator listed
Recruiting
Assaf Harofeh hospital, Shamir Medical Center
Ẕerifin, Israelstudy coordinator listed
Recruiting
Bihor County Emergency Clinical Hospital
Oradea, Romaniastudy coordinator listed
Recruiting
Bioresearch Partner - Aventura
Aventura, Floridastudy coordinator listed
Recruiting
Bioresearch Partner - Hialeah Hospital
Hialeah, Floridastudy coordinator listed
Recruiting
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolinastudy coordinator listed
Recruiting
Clinical Hospital of the Ministry of Internal Affairs and Administration with Warmia and Mazury Oncology Centre in Olsztyn
Olsztyn, Polandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Derrick McKinley, MD · STUDY_DIRECTOR · UroGen Pharma
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Complete response rate (CRR)3 months
CRR is defined as the proportion of patients who achieved CR at the PDE Visit.