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Upper Urinary Tract Urothelial CarcinomaPhase 3NCT06774131

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer

A Phase 3 study testing UGN-104 in people with Upper Urinary Tract Urothelial Carcinoma and Urothelial Carcinoma, run by UroGen Pharma Ltd. at 79 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
UGN-104
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
79 sitesin 9 countries
Study dates
6 Aug 2025to Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.
  • Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system, with the following disease characteristics:
  • At least 1 measurable papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15 mm. Debulking to ≤ 15 mm is permitted.
  • Biopsy taken from at least 1 tumor located above the ureteropelvic junction revealing LG urothelial carcinoma (UC). Patients who have been biopsied within 8 weeks before Screening for this study and shown to have LG UC may have these historical biopsies used for enrollment into the study and do not require repeat biopsy during Screening.
  • Patient should have at least 1 remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm post-biopsy.
  • Wash urine cytology sampled from the pyelocalyceal system documenting the absence of high-grade (HG) UC, diagnosed not more than 8 weeks before Screening.
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  • Patients with bilateral LG-UTUC may be enrolled if at least 1 side meets the inclusion criteria for the study and if the other kidney does not require further treatments. (The disease in the other kidney must be completely ablated before receiving treatment in the study.) Note: If both upper tracts meet inclusion criteria, the treating urologist in consultation with the sponsor's medical monitor can decide which side to treat in the study. The pyelocalyceal system not under study must be free of cancer before the first instillation on the side to be treated in the study.
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status < 3 (with Karnofsky > 40).
  • Patients with life expectancy > 24 months at time of Screening.
  • Patients must have adequate organ and bone marrow function as determined by the following routine laboratory tests:
  • Leukocytes ≥ 3,000/μL (≥ 3 × 10^9/L).
  • Absolute neutrophil count ≥ 1,500/μL (≥ 1.5 × 10^9/L).
  • Platelets ≥ 100,000/μL (≥ 100 × 10^9/L).
  • Hemoglobin ≥ 9.0 g/dL.
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
  • Alkaline phosphatase ≤ 2.5 × ULN.
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
  • Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis. Note: In case of a symptomatic UTI the patient will be treated with antibiotics and the instillation will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of treatment is at the discretion of the investigator.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants.
  • Female patients of childbearing potential (defined as premenopausal women who have not been sterilized) and male patients with female partners of childbearing potential must agree to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment. Sexually active male patients must agree to use a condom during intercourse for at least 48 hours after each instillation.
  • Acceptable methods of birth control considered to have a low failure rate (ie, less than 1% per year) when used consistently and correctly include implants, injectable, combined (estrogen/progesterone) oral contraceptives, intrauterine devices (only hormonal), condoms with spermicide, sexual abstinence or vasectomized partner.
  • Sexual abstinence is defined as refraining from intercourse from enrollment through 6 months post treatment. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is NOT an acceptable method of contraception.

Who cannot join

  • UC specific exclusions:
  • Patient received Bacillus Calmette-Guérin (BCG) treatment for UC during the 6 months before enrollment.
  • The patient has untreated concurrent UC in locations other than the target area (unless treated and resolved during Screening); ie, ureteral and lower urinary tract tumors must be completely ablated before entry.
  • Patient has a history of carcinoma in situ (CIS) in the urinary tract.
  • Patient has a history of invasive UC in the past 5 years.
  • Patient has a history of HG papillary UC in the urinary tract in the past 2 years.
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  • Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the study.
  • Any other malignancy diagnosed within 2 years before enrollment with the exception of:
  • Basal or squamous cell skin cancers.
  • Noninvasive cancer of the cervix.
  • Any other cancer deemed to be of low risk for progression or patient morbidity during the study period in the opinion of the investigator.
  • Patient with urinary obstruction such that there is an inability to deliver the study treatment to the pyelocalyceal system either via ureteral catheter (retrograde administration) or nephrostomy tube (antegrade administration).
  • Known allergy or sensitivity to any component of the study treatment (including excipients) that in the investigator's opinion cannot be readily managed.
  • Patient has an intractable bleeding disorder (eg, coagulation factors deficiencies, Von Willebrand disease).
  • Patient is currently receiving any other investigational product, has participated in a research protocol involving administration of an investigational product in the past 30 days, or plans to participate in a research protocol involving administration of an investigational product during study conduct.
  • Patient was previously treated with JELMYTO (product code UGN-101) for UTUC.
  • Women who are pregnant (positive urine or serum pregnancy test), planning to become pregnant during the study period, or who are breastfeeding are not eligible to enroll.
  • Patient has any other medical or mental condition(s) that make(s) his/her participation in the study unadvisable in the opinion of the investigator.
  • Where applicable per country regulation, the patient must not be currently committed to an institution by virtue of an order issued by either judicial or administrative authorities.

Trial locations and contacts

79 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Renee Sumlin contact

346-573-2671

renee.sumlin@urogen.com

Yafit Makmal contact

yafit.makmal@urogen.com

79 sites in 9 countries

United States34 sites, 31 recruiting

  • Amarillo Urology Research

    Amarillo, Texas, 79106

    Completed

  • University of Arkansas for Medical Sciences

    Arkansas City, Arkansas, 72205

    Marquita Curry, +1 (501) 686 8274, MCurry2@uams.edu

    Marcelo Bigarella, MD

    Recruiting

  • UPNT Research Institute, LLC

    Arlington, Texas, 76017

    Grace Yoon, 682) 205-8396, grace.yoon@objective.health

    Harrison Abrahams

    Recruiting

  • Texas Urology Specialists-Austin

    Austin, Texas, 78705

    Sarah Gerard, 512-421-4183, Sarah.Gerard@usoncology.com

    Kyle Keyes

    Recruiting

  • Bioresearch Partner - Aventura

    Aventura, Florida, 33180

    Jonathan Matias, 833-489-4968, jmatias@bioresearchpartner.com

    Angelo Gousse

    Recruiting

  • Michael G Oefelein Clinical Trials

    Bakersfield, California, 93301

    Evelyn De La Cruz, 661-310-1063, edelacruz@droefelein.com

    Michael Oefelein

    Recruiting

  • Arizona State Urological Research Institute, LLC ("ASURI")

    Chandler, Arizona, 85225

    Dianna Baldonado, 602-842-5303, dbaldonado@asuri.net

    Pratik Patel

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Matvey Tsivian, 843-792-7888, tsivian@musc.edu

    Matvey Tsivian

    Recruiting

  • Urology Specialists of the Carolinas, PLLC

    Charlotte, North Carolina, 28204

    Shavon Lotharp, +1 (336) 223 4017, slotharp@folioclinicalresearch.com

    Jeremy Hubbard, MD

    Recruiting

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22908

    Olusegun Adelaja, 434-760-6337, OBA4E@uvahealth.org

    Francesca Whitfield, 434-760-6337, FBW3MG@uvahealth.org

    Recruiting

  • University of Cincinnati Medical Center (UCMC)

    Cincinnati, Ohio, 45219

    Jess Harpel, 513-584-6643, harpelja@ucmail.uc.edu

    Alberto Martini

    Recruiting

  • Urology Center of Iowa Research

    Clive, Iowa, 50325

    Danielle Hahn, (515) 992-7718, danielle.hahn@objective.health

    Brian Gallagher

    Recruiting

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

    Sarah Jewell Study Coordinator, +1 (614) 366 7421, CTO.implementation@osumc.edu

    Ahmad Shabsigh, MD

    Recruiting

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Completed

  • University of Florida Health (UF Health), Cancer Center

    Gainesville, Florida, 32610

    Danielle R Geckler, 352.273.8236, d.geckler@ufl.edu

    Padraic O Malley

    Recruiting

  • Urology Specialists of the Carolinas - Greensboro

    Greensboro, North Carolina, 27403

    Jeremy Hubbard, MD, (336) 274-1114, jsladehubbard@gmail.com

    Jeremy Hubbard, MD

    Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Sneha Patel, 717-531-0003 ext. 283173, spatel42@pennstatehealth.psu.edu

    Jay Raman

    Recruiting

  • Bioresearch Partner - Hialeah Hospital

    Hialeah, Florida, 33013

    Tahimi De La De La Campa, 833-489-4968, tdelacampa@bioresearchpartner.com

    Luis Rangel

    Recruiting

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

    Rita Aderholt, 205.445.0124, raderholt@urologyal.com

    Michael Eric Brewer

    Recruiting

  • Houston Metro Urology (HMU) - Southwest Location

    Houston, Texas, 77027

    Jonathan Conley, +1 (713) 351 5015, Jonathan.conley@hmutx.com

    Zvi Schiffman, MD

    Recruiting

  • Lumi Research - Houston

    Houston, Texas, 77090

    Alexis Chaviz, +1 832 553 3661, achavez@lumiresearch.com

    Pullin Pandya, MD

    Recruiting

  • D&H National Research Centers - Cancer Research Center, LLC

    Margate, Florida, 33063

    Gabriel Khawam, +1 (786) 375 6210, gkhawam@dhnrc.com

    Emilio Araujo-Mino, MD

    Recruiting

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572

    Abhishek Srivastava, 843-839-1679, abhishek.srivastava@startresearch.com

    Abhishek Srivastava

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Kevin Lee, +732 (754) 8707, kl1072@cinj.rutgers.edu

    Saum Ghodoussipour, MD

    Recruiting

  • Low county Urology Clinics

    North Charleston, South Carolina, 29406

    Samara Grimes, 843-725-4414, sgrimes@lcurology.com

    Justin Ellett

    Recruiting

  • The Urology Center, P.C.

    Omaha, Nebraska, 68114

    Completed

  • UC Irvine Health. Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Edward Uchio, (714) 456-6717, euchio@hs.uci.edu

    Edward Uchio

    Recruiting

  • East Valley Urology Center of Arizona

    Queen Creek, Arizona, 85140

    Vicky Camacho, +1 (480) 219 1010, vcamacho@folioclinicalresearch.com

    Harpreet Wadhwa, MD

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Marcus D'Alfonso, +1 (585) 275 0126, Marcus_dalfonso@urmc.rochester.edu

    Phillip Rappold, MD

    Not yet recruiting

  • USA Operation d/b/a US Clinical Trials

    San Antonio, Texas, 78229

    Valerie Strickland, +1 (703) 280 5390, vstrickland@nextoncology.com; valerie.strickland@usa-clinicaltrials.com

    Jose De La Cerda, MD

    Recruiting

  • Montefiore Medical Center - Bronx

    The Bronx, New York, 10461

    Andrea Asencio, +1 (347) 842 1715, aasencio@montefiore.org

    Alexander Small, MD

    Recruiting

  • Renovatio Clinical - The Woodlands Research Center

    The Woodlands, Texas, 77380

    Pablo Villarreal, +713 (703) 2398, pablo.villarreal@renovatioclinical.com

    Mahran Shoukier, MD

    Recruiting

  • Urologic Specialists of Oklahoma

    Tulsa, Oklahoma, 74146-5830

    Nosayaba Ugbo, +1 (918) 938 1590, Nosayaba.Ugbo@milestoneone.com

    John Forrest, MD

    Recruiting

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Win Phyu, +1 (202) 877 3061, Win.Phyu@medstar.net

    Lambros Stamatakis, MD

    Recruiting

Other trials in United States

Spain10 sites, 10 recruiting

  • University Hospital Complex A Coruna (CHUAC), Department of Urology

    A Coruña, Galicia

    Dario Vazquez-Martul, MD, +34 (981) 178 057, dario.martul@gmail.com

    Dario Vazquez-Martul

    Recruiting

  • Puigvert Foundation

    Barcelona, Catalonia, 08025

    Vanesa Munoz, +34 (9341) 69 700, vmunoz@fundacio-puigvert.es

    Alberto Breda, MD

    Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

    Cristina Fernández, 34956003096, crisferavi@gmail.com

    Jesús Rosety Rodriguez

    Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

    Manuel Sanchez, 34957010380, sanchez.oncologia@gmail.com

    Juan Manuel Rubio Galisteo

    Recruiting

  • University Hospital de La Princesa

    Madrid, Madrid, 28006

    Luis A. San Jose Manso, MD, +34 (627) 583 960, lsanjose.hcsc@salud.madrid.org

    Luis A. San Jose Manso, MD

    Recruiting

  • University Hospital Clinical San Carlos, Department of Urology

    Madrid, Madrid, 28040

    Maria Isabel Galante Romo, MD, +34 (91) 330 3001, m.isabel.galante@gmail.com

    Maria Isabel Galante Romo, MD

    Recruiting

  • University Hospital Ramon y Cajal

    Madrid, Madrid

    Lucia Almagro, + (34) 91 336 80 13, lucia.almagro@salud.madrid.org

    Victoria Gomez Dos Santos, MD

    Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

    Tomás Fernández Aparicio, 34968 36 09 00, tomas.fernandez3@carm.es

    Tomás Fernández Aparicio

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Mónica Suengas, 676366754, moni.suengas@gmail.com

    Carlos González Cáliz

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

    Jose María Martinez Jabaloyas, 34639716989, marjabaloyas@gmail.com

    Jose María Martinez Jabaloyas

    Recruiting

Other trials in Spain

Poland8 sites, 7 recruiting

  • IN-VIVO Limited Liability Company

    Bydgoszcz, 85-048

    Anna Wileńska, 723 351 032, anna.wilenska@in-vivo.pl

    Piotr Piasecki

    Recruiting

  • University Clinical Center in Gdansk, Department of urology

    Gdansk, Pomeranian

    Completed

  • NZOZ Silesian Urology Hospital

    Katowice, 40-073

    Igal Mor, 735254562 ; 606 959 217, igal.mor@grupamazovia.pl

    Igal Mor

    Recruiting

  • St. John of Dukla Oncology Center of Lublin Land

    Lublin, 20-090

    Robert Klijer, +48 () 603656516, klijerr@gmail.com ; r.klijer@coz.pl

    Robert Klijer, MD

    Recruiting

  • Clinical Hospital of the Ministry of Internal Affairs and Administration with Warmia and Mazury Oncology Centre in Olsztyn

    Olsztyn, 10-228

    Klaudia Dzienis, +48 (89) 539 8757, klaudia.dzienis@poliklinika.net

    Roman Sosnowski, MD

    Recruiting

  • Opole University Clinical Hospital (USK Opole)

    Opole, Opole Voivodeship, 45-401

    Angelika Zurawska, +(48) 726617898, angelika.zurawska@usk.opole.pl

    Marcin Zyczkowski, MD

    Recruiting

  • Independent Public Teaching Hospital #2

    Szczecin, 70-111

    Monika Chomej-Dabrowska, 510 926 935, monika.chomej.dabrowska@pum.edu.pl

    Marcin Slojewski, MD

    Recruiting

  • Jan Mikulicz-Radecki University Clinical Hospital in Wroclaw

    Wroclaw, 50-556

    Adrianna Jezierzańska, +48 608 615 808, adr.rogowska.usk@gmail.com

    Anna Kołodziej

    Recruiting

Other trials in Poland

Georgia7 sites, 7 recruiting

  • LTD West Regional Center of Modern Medical Technologies

    Kutaisi, Imereti

    Melania Godoladze, +995 (579) 164-165, melaniegodoladze@gmail.com

    Merab Bzikadze, MD

    Recruiting

  • Guram Karazanashvili Robotic Center LLC

    Tbilisi, K'alak'i T'bilisi

    Nato Mazmishvili, +995 (599) 733 399, nata_nataly2000@yahoo.com

    Guram Karazanashvili, MD

    Recruiting

  • JSC Jerarsi

    Tbilisi, K'alak'i T'bilisi

    Goga Izoria, +995 (599) 776-337, Goga.izoria.ge@gmail.com

    Alexandre Khuskivadze, MD

    Recruiting

  • LTD "Israel-Georgian Medical Research Clinic "Healthycore"

    Tbilisi, 0112

    Ani Atabegashvili, +995 577 71 90 11, atabegashvili1998@gmail.com

    Ekaterine Arkania

    Recruiting

  • JSC "Vian"-I.Bokeria University Hospital

    Tbilisi, 0137

    Salome Tatoshvili, +995 592 81 82 70, tatoshvilisalome@gmail.com

    Koba Kiknavelidze

    Recruiting

  • LTD "Geo Hospitals"

    Tbilisi, 0144

    Peride Okujava, +995 591 02 80 03, okujavaf@gmail.com

    Giorgia Adeishvili

    Recruiting

  • LTD "Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic"

    Tbilisi, 0144

    Liana Karichashvili, +995 592 10 09 79, lika.karichashvili@gmai.com

    Shalva Chovelidze

    Recruiting

Other trials in Georgia

Romania6 sites, 6 recruiting

  • "Dr. Carol Davila" Nephrology Clinical Hospital Bucharest

    Bucharest, Bucharest

    Marius Tudor Radu, MD, +40 (746) 183 386, tudor.radu@yahoo.com

    Marius Tudor Radu, MD

    Recruiting

  • Delta Health Care S.R.L.

    Bucharest, Bucharest

    Ana Ologeanu, +40- (72) -786-1744, ana.ologeanu@reginamaria.ro

    Dragos Razvan Multescu, MD

    Recruiting

  • Municipal Clinical Hospital Cluj-Napoca

    Cluj-Napoca, 400139

    Elena Timofte, +40748 101 110, drelenatimofte@gmail.com

    Ramona Doina Matei

    Recruiting

  • Regional Institute of Oncology Iasi

    Iași, 700483

    Marinca Mihai, +40752 183 186, marincaRCT@gmail.com

    Teodora Alexa Stratulat

    Recruiting

  • Bihor County Emergency Clinical Hospital

    Oradea, 410169

    Vlad Barbos, +40746 848 349, vlad_barbos94@yahoo.com

    Mihail Claudius Berechet

    Recruiting

  • Timisoara County Clinical Emergency Hospital Pius Brinzeu

    Timișoara, 300723

    Mattar lasmina, +40752211301, jasminnetm@gmail.com

    Razvan Tiberiu Bardan

    Recruiting

Other trials in Romania

Israel5 sites, 5 recruiting

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

    Reem Abado, 972-4-8844431, ReemAba@clalit.org.il

    Yuval Freifeld

    Recruiting

  • Meir Medical Center, Department of Urology

    Kefar Sava, Israel, 4428164

    Adi Kfir, 972-54-4420567, adikf@clalit.org.il

    Omri Schwarztuch Gildor

    Recruiting

  • Rabin Medical Center - Hasharon hospital

    Petah Tikva, 4937211

    Dana Nuriely, 972-50-6770097, dananu1@clalit.org.il

    David Lifshitz

    Recruiting

  • Sheba Medical Center

    Ramat Gan, Israel, 5262000

    Efrat Levi, 972-54-5446438 972-3-5302007, efrat.ezra@sheba.health.gov.il

    Nir Kleinmann

    Recruiting

  • Assaf Harofeh hospital, Shamir Medical Center

    Ẕerifin, 70500

    Adam Altman, 972-52-2391871, Adamal@shamir.gov.il

    Amnon Zisman

    Recruiting

Other trials in Israel

Bulgaria4 sites, 4 recruiting

  • MHAT Haskovo AD

    Haskovo, 6300

    Veselina Stileva, +359 892226067, v.stileva@rdservices.org

    Ivan Nikolov

    Recruiting

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv

    Plovdiv, Plovdiv, 4002

    Nikoleta Kadisheva, +359 (882) 730 033, nikoleta.kadisheva@clineca.net

    Petar Antonov, MD

    Recruiting

  • Multiprofile Hospital for Active Treatment - Shumen, Department of Urology

    Shumen, Shumen, 9700

    Rositsa Gencheva, +359 (896) 515-272, rositsa.gencheva@pratia.com

    Dobri Marchev, MD

    Recruiting

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov," Sofia, Clinic of Urology

    Sofia, 1000

    Iglika Mladenova, +359 89 222 6068, i.mladenova@rdservices.org

    Boris Mladenov

    Recruiting

Other trials in Bulgaria

Latvia3 sites, 3 recruiting

  • Liepajas Regional Hospital, Kurzeme Urology Center

    Liepāja, Liepaja, LV-3414

    Kristina Melbarde, +371 (261) 79 636, kristinamelbarde@inbox.lv

    Dzintra Litavniece, MD

    Recruiting

  • LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology

    Riga, Riga, LV-1079

    Aleksandrs Dorogojs, +371 (29) -779-140, aleksandrs.dorogojs@gmail.com

    Vilnis Lietuvietis, MD

    Recruiting

  • P. Stradins Clinical University Hospital, Center for Urology

    Riga, Riga

    Diana Zogota, +0 (371) 27059722, zogota.diana@gmail.com

    Egils Vjaters, MD

    Not yet recruiting

Other trials in Latvia

Hungary2 sites, 1 recruiting

  • Semmelweis University, Department of Urology

    Budapest, Budapest

    Completed

  • University of Debrecen Clinical Center, Department of Urology

    Debrecen, 4032

    Anita Gyori, +36 (52) 411 717, flash@med.unideb.hu; flash@dote.hu

    Tibor Flasko, MD

    Recruiting

Other trials in Hungary

About this study

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)

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).

Read the detailed description

Eligible patients will be treated with UGN-104 once weekly for 6 weeks (a total of 6 doses).

Efficacy will be assessed by the complete response rate (CRR) at the Primary Disease Evaluation (PDE) Visit (approximately 3 months after the first instillation). Response will be determined based on central laboratory interpretation of UUT wash urine cytology and visual evaluation (ureteroscopy). Biopsy of any remaining or new lesions will be performed where technically feasible and the central laboratory histopathology assessment will also be used in the response determination, if applicable.

Patients who have a complete response (CR) at the PDE Visit, defined as having no detectable disease (NDD), will enter the Follow-up Period of the study. During the Follow-up Period, patients may receive UGN-104 as maintenance treatment at the discretion of the investigator. The maintenance regimen is once monthly for 11 months (a total of 11 doses) and should start as soon as possible (no longer than 3 weeks) after CR is determined at the PDE Visit.

All patients in the Follow-up Period, regardless of whether they receive maintenance treatment, will return to the clinic every 3 months for evaluation of response and will remain on study for 12 months after the PDE Visit or until disease recurrence, disease progression, or death, whichever occurs first.

Patients who have a non-complete response (NCR) at the PDE Visit will be considered to have completed the study.

Being tested
UGN-104
Keywords
UTUC, Low Grade UTUC, Low-grade Upper Tract Urothelial Cancer, UGN-104, Mitomycin, Nephrostomy Tube, LG-UTUC, UGN-101
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UGN-104Drug

    Also called UGN-104 (mitomycin) for pyelocalyceal solution

    UGN-104 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-104 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the UUT.

Study groups in NCT06774131
Study groupRoleWhat they receive
UGN-104ExperimentalPatients will receive UGN-104 once weekly for 6 weeks (a total of 6 doses). The dose of UGN-104 to be instilled is 4 mg mitomycin per 1 mL sterile hydrogel via ureteral catheter (retrograde administration) or nephrostomy tube (antegrade administration). Patients who have a CR at the PDE Visit will enter the Follow-up Period and may receive UGN-104 as maintenance treatment once monthly for 11 months (a total of 11 doses) at the discretion of the investigator.
Receives: Drug: UGN-104

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate (CRR)

    CRR is defined as the proportion of patients who achieved CR at the PDE Visit.

    Measured: 3 months

Secondary outcomes (8)

  1. Duration of response (DOR)

    DOR is defined as the time from the date of evidence of CR at the PDE Visit to the earliest date of recurrence, progression, or death due to any cause, whichever occurred first.

    Measured: 12 months

  2. Durable complete response (DCR) rate

    DCR rate at scheduled disease assessment time points, defined as the proportion of patients who achieved CR at the PDE Visit and maintained CR (ie, no detectable disease) up to that particular follow-up disease assessment.

    Measured: 12 months

  3. Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology and serum chemistry)

    The number of patients with each type of event will be summarized.

    Measured: 15 months

  4. Mitomycin plasma concentrations

    Mitomycin plasma concentrations will be assessed in a subset of patients treated with UGN-104.

    Measured: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-104

  5. Mitomycin maximum plasma concentration (Cmax)

    Mitomycin Cmax will be assessed in a subset of patients treated with UGN-104.

    Measured: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-104

  6. Mitomycin time to maximum plasma concentration (tmax)

    Mitomycin tmax will be assessed in a subset of patients treated with UGN-104.

    Measured: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-104

  7. Mitomycin area under the concentration-time curve (AUC)

    Mitomycin AUC will be assessed in a subset of patients treated with UGN-104.

    Measured: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-104

  8. Mitomycin terminal half-life (t1/2)

    Mitomycin t1/2 will be assessed in a subset of patients treated with UGN-104.

    Measured: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start6 Aug 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06774131
Sponsor's protocol ID
UT002
Other IDs
2024-519343-15-00
Status last verified
Sep 2026
First submitted
8 Jan 2025
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing UGN-104 in people with Upper Urinary Tract Urothelial Carcinoma and Urothelial Carcinoma, run by UroGen Pharma Ltd. at 79 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Spain, Poland, Georgia, Romania and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Renee Sumlin (346-573-2671, renee.sumlin@urogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (CRR) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06774131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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