Actively Recruiting
A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
Led by UroGen Pharma Ltd. · Updated on 2026-04-29
70
Participants Needed
52
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and agree to study requirements.
- Have low-grade, non-invasive upper tract urothelial carcinoma with at least one measurable papillary tumor 15 mm or smaller.
- Biopsy confirming low-grade urothelial carcinoma above the ureteropelvic junction.
- Have at least one remaining papillary tumor 5 mm or larger after biopsy.
- No high-grade urothelial carcinoma detected by urine cytology within 8 weeks before screening.
- Patients with bilateral low-grade tumors may participate if one side meets criteria and the other kidney is cancer-free.
- Eastern Cooperative Oncology Group (ECOG) performance status less than 3 and Karnofsky score over 40.
- Life expectancy greater than 24 months at screening.
- Adequate organ and bone marrow function confirmed by laboratory tests.
- No active urinary tract infection confirmed by urine tests.
- Agree to use effective contraception during the study and for 6 months after treatment.
You will not qualify if you...
- Received BCG treatment for urothelial cancer within 6 months prior to enrollment.
- Have untreated urothelial cancer outside the target area.
- History of carcinoma in situ or invasive urothelial carcinoma in the past 5 years.
- History of high-grade papillary urothelial carcinoma in the urinary tract within 2 years.
- Currently receiving or planning systemic chemotherapy during the study.
- Any other malignancy diagnosed within 2 years, except certain low-risk skin or cervical cancers.
- Urinary obstruction preventing delivery of study treatment.
- Allergy or sensitivity to study treatment components.
- Bleeding disorders that cannot be managed.
- Participation in other investigational studies within 30 days before or during this study.
- Prior treatment with JELMYTO (UGN-101) for upper tract urothelial cancer.
- Pregnancy, planning pregnancy, or breastfeeding.
- Medical or mental conditions that make participation unsafe.
- Legal commitment to an institution by judicial or administrative order where applicable.
AI-Screening
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Trial Site Locations
Total: 52 locations
1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
Actively Recruiting
2
Arizona State Urological Research Institute, LLC ("ASURI")
Chandler, Arizona, United States, 85225
Actively Recruiting
3
1155 E. Combs Rd, Suite 105, Queen Creek, AZ, 85140, USA
Queen Creek, Arizona, United States, 85140
Actively Recruiting
4
Michael G Oefelein Clinical Trials
Bakersfield, California, United States, 93301
Actively Recruiting
5
University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
6
BioResearch Partners Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
7
UF Health Cancer Center University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
8
BioResearch Partners Hialeah
Hialeah, Florida, United States, 33013
Actively Recruiting
9
D&H National Research Centers - Cancer Research Center, LLC
Margate, Florida, United States, 33063
Actively Recruiting
10
Urology Center of Iowa Research
Clive, Iowa, United States, 50325
Actively Recruiting
11
The Urology Center, P.C.
Omaha, Nebraska, United States, 68114
Actively Recruiting
12
Montefiore Medical Center - Bronx
The Bronx, New York, United States, 10461
Actively Recruiting
13
University of Cincinnati Medical Center (UCMC)
Cincinnati, Ohio, United States, 45219
Actively Recruiting
14
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
15
Urologic Specialists of Oklahoma
Tulsa, Oklahoma, United States, 74146-5830
Actively Recruiting
16
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
17
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
18
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
19
Low county Urology Clinics
North Charleston, South Carolina, United States, 29406
Actively Recruiting
20
Amarillo Urology Research
Amarillo, Texas, United States, 79106
Actively Recruiting
21
UPNT Research Institute, LLC
Arlington, Texas, United States, 76017
Actively Recruiting
22
Texas Urology Specialists-Austin
Austin, Texas, United States, 78705
Actively Recruiting
23
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
24
MHAT Haskovo AD
Haskovo, Bulgaria, 6300
Actively Recruiting
25
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov," Sofia, Clinic of Urology
Sofia, Bulgaria, 1000
Actively Recruiting
26
LTD "Israel-Georgian Medical Research Clinic "Healthycore"
Tbilisi, Georgia, 0112
Actively Recruiting
27
JSC "Vian"-I.Bokeria University Hospital
Tbilisi, Georgia, 0137
Actively Recruiting
28
LTD "Geo Hospitals"
Tbilisi, Georgia, 0144
Actively Recruiting
29
LTD "Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic"
Tbilisi, Georgia, 0144
Actively Recruiting
30
University of Debrecen Clinical Center, Department of Urology
Debrecen, Hungary, 4032
Actively Recruiting
31
Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
32
Meir Medical Center, Department of Urology
Kefar Sava, Israel, 4428164
Actively Recruiting
33
Rabin Medical Center - Hasharon hospital
Petah Tikva, Israel, 4937211
Actively Recruiting
34
Sheba Medical Center
Ramat Gan, Israel, 5262000
Actively Recruiting
35
Sheba Medical Center
Ramat Gan, Israel, 5262000
Actively Recruiting
36
Assaf Harofeh hospital, Shamir Medical Center
Ẕerifin, Israel, 70500
Actively Recruiting
37
IN-VIVO Limited Liability Company
Bydgoszcz, Poland, 85-048
Actively Recruiting
38
NZOZ Silesian Urology Hospital
Katowice, Poland, 40-073
Actively Recruiting
39
St. John of Dukla Oncology Center of Lublin Land
Lublin, Poland, 20-090
Actively Recruiting
40
Clinical Hospital of the Ministry of Internal Affairs and Administration with Warmia and Mazury Oncology Centre in Olsztyn
Olsztyn, Poland, 10-228
Actively Recruiting
41
Independent Public Teaching Hospital #2
Szczecin, Poland, 70-111
Actively Recruiting
42
Jan Mikulicz-Radecki University Clinical Hospital in Wroclaw
Wroclaw, Poland, 50-556
Actively Recruiting
43
Municipal Clinical Hospital Cluj-Napoca
Cluj-Napoca, Romania, 400139
Actively Recruiting
44
Regional Institute of Oncology Iasi
Iași, Romania, 700483
Actively Recruiting
45
Bihor County Emergency Clinical Hospital
Oradea, Romania, 410169
Actively Recruiting
46
Timisoara County Clinical Emergency Hospital Pius Brinzeu
Timișoara, Romania, 300723
Actively Recruiting
47
15006
A Coruña, Galicia, Spain
Actively Recruiting
48
Hospital Universitario Puerta del Mar
Cadiz, Spain, 11009
Actively Recruiting
49
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Actively Recruiting
50
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Actively Recruiting
51
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
52
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
R
Renee Sumlin
CONTACT
Y
Yafit Makmal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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