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New cancer gel shows promise for rare urinary tract tumors

NCT ID NCT06774131

Disease control Sponsor: UroGen Pharma Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests a new gel-like drug, UGN-104, placed directly into the upper urinary tract to treat low-grade cancer. About 70 adults with small tumors will receive the treatment to see if it can completely eliminate visible cancer. The goal is to control the disease and avoid more invasive surgery.

Why investors are watching

UroGen Pharma is running a phase 3 trial of UGN-104, a new formulation of its approved drug JELMYTO, for low-grade upper tract urothelial cancer. The trial enrolls 70 patients and tests whether the drug controls the disease. For a small company, this readout matters because UGN-104 could extend the life of its core product line.

If it works: A positive result could lead to regulatory approval and give UroGen a second product based on an already-approved drug. That would broaden its commercial options without starting from scratch.

If it fails: The trial could fail to show sufficient efficacy or safety, which would delay or block approval. Trials fail often, and a setback here would hurt a small company that depends on this drug's success.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol. 2. Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system, with the following disease characteristics: 1. 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. 2. 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. 3. Patient should have at least 1 remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm post-biopsy. 4. Wash urine cytology sampled from the pyelocalyceal system documenting the absence of high-grade (HG) UC, diagnosed not more than 8 weeks before Screening. 5. 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. 3. Patients with Eastern Cooperative Oncology Group (ECOG) performance status \< 3 (with Karnofsky \> 40). 4. Patients with life expectancy \> 24 months at time of Screening. 5. Patients must have adequate organ and bone marrow function as determined by the following routine laboratory tests: 1. Leukocytes ≥ 3,000/μL (≥ 3 × 10\^9/L). 2. Absolute neutrophil count ≥ 1,500/μL (≥ 1.5 × 10\^9/L). 3. Platelets ≥ 100,000/μL (≥ 100 × 10\^9/L). 4. Hemoglobin ≥ 9.0 g/dL. 5. Total bilirubin ≤ 1.5 × upper limit of normal (ULN). 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. 7. Alkaline phosphatase ≤ 2.5 × ULN. 8. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min. 6. 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. 7. 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. Exclusion Criteria: 1. UC specific exclusions: 1. Patient received Bacillus Calmette-Guérin (BCG) treatment for UC during the 6 months before enrollment. 2. 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. 3. Patient has a history of carcinoma in situ (CIS) in the urinary tract. 4. Patient has a history of invasive UC in the past 5 years. 5. Patient has a history of HG papillary UC in the urinary tract in the past 2 years. 2. Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the study. 3. Any other malignancy diagnosed within 2 years before enrollment with the exception of: 1. Basal or squamous cell skin cancers. 2. Noninvasive cancer of the cervix. 3. Any other cancer deemed to be of low risk for progression or patient morbidity during the study period in the opinion of the investigator. 4. 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). 5. Known allergy or sensitivity to any component of the study treatment (including excipients) that in the investigator's opinion cannot be readily managed. 6. Patient has an intractable bleeding disorder (eg, coagulation factors deficiencies, Von Willebrand disease). 7. 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. 8. Patient was previously treated with JELMYTO (product code UGN-101) for UTUC. 9. 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. 10. 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. 11. 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.

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Conditions

The condition(s) this trial relates to.

renal pelvis/ureter urothelial carcinoma transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Upper urinary tract urothelial carcinoma Urothelial carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    74 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "Dr. Carol Davila" Nephrology Clinical Hospital Bucharest

    RECRUITING

    Bucharest, Bucharest, Romania

  • Amarillo Urology Research

    COMPLETED

    Amarillo, Texas, 79106, United States

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

    RECRUITING

    Chandler, Arizona, 85225, United States

  • Assaf Harofeh hospital, Shamir Medical Center

    RECRUITING

    Ẕerifin, 70500, Israel

  • Bihor County Emergency Clinical Hospital

    RECRUITING

    Oradea, 410169, Romania

  • Bioresearch Partner - Aventura

    RECRUITING

    Aventura, Florida, 33180, United States

  • Bioresearch Partner - Hialeah Hospital

    RECRUITING

    Hialeah, Florida, 33013, United States

  • Carolina Urologic Research Center, LLC

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

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

    RECRUITING

    Olsztyn, 10-228, Poland

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

    RECRUITING

    Margate, Florida, 33063, United States

  • Delta Health Care S.R.L.

    RECRUITING

    Bucharest, Bucharest, Romania

  • East Valley Urology Center of Arizona

    RECRUITING

    Queen Creek, Arizona, 85140, United States

  • Guram Karazanashvili Robotic Center LLC

    RECRUITING

    Tbilisi, K'alak'i T'bilisi, Georgia

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Morales Meseguer

    RECRUITING

    Murcia, 30008, Spain

  • Hospital Universitario Puerta del Mar

    RECRUITING

    Cadiz, 11009, Spain

  • Hospital Universitario Reina Sofía

    RECRUITING

    Córdoba, 14004, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Houston Metro Urology (HMU) - Southwest Location

    RECRUITING

    Houston, Texas, 77027, United States

  • IN-VIVO Limited Liability Company

    RECRUITING

    Bydgoszcz, 85-048, Poland

  • Independent Public Teaching Hospital #2

    RECRUITING

    Szczecin, 70-111, Poland

  • JSC "Vian"-I.Bokeria University Hospital

    RECRUITING

    Tbilisi, 0137, Georgia

  • JSC Jerarsi

    RECRUITING

    Tbilisi, K'alak'i T'bilisi, Georgia

  • Jan Mikulicz-Radecki University Clinical Hospital in Wroclaw

    RECRUITING

    Wroclaw, 50-556, Poland

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

    RECRUITING

    Riga, Riga, LV-1079, Latvia

  • LTD "Geo Hospitals"

    RECRUITING

    Tbilisi, 0144, Georgia

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

    RECRUITING

    Tbilisi, 0112, Georgia

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

    RECRUITING

    Tbilisi, 0144, Georgia

  • LTD West Regional Center of Modern Medical Technologies

    RECRUITING

    Kutaisi, Imereti, Georgia

  • Lady Davis Carmel Medical Center

    RECRUITING

    Haifa, 3436212, Israel

  • Liepajas Regional Hospital, Kurzeme Urology Center

    RECRUITING

    Liepāja, Liepaja, LV-3414, Latvia

  • Low county Urology Clinics

    RECRUITING

    North Charleston, South Carolina, 29406, United States

  • Lumi Research - Houston

    RECRUITING

    Houston, Texas, 77090, United States

  • MHAT Haskovo AD

    RECRUITING

    Haskovo, 6300, Bulgaria

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medstar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Meir Medical Center, Department of Urology

    RECRUITING

    Kefar Sava, Israel, 4428164, Israel

  • Michael G Oefelein Clinical Trials

    RECRUITING

    Bakersfield, California, 93301, United States

  • Montefiore Medical Center - Bronx

    RECRUITING

    The Bronx, New York, 10461, United States

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

    RECRUITING

    Shumen, Shumen, 9700, Bulgaria

  • Municipal Clinical Hospital Cluj-Napoca

    RECRUITING

    Cluj-Napoca, 400139, Romania

  • NZOZ Silesian Urology Hospital

    RECRUITING

    Katowice, 40-073, Poland

  • Opole University Clinical Hospital (USK Opole)

    RECRUITING

    Opole, Opole Voivodeship, 45-401, Poland

  • P. Stradins Clinical University Hospital, Center for Urology

    NOT_YET_RECRUITING

    Riga, Riga, Latvia

  • Penn State Milton S Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Puigvert Foundation

    RECRUITING

    Barcelona, Catalonia, 08025, Spain

  • Rabin Medical Center - Hasharon hospital

    RECRUITING

    Petah Tikva, 4937211, Israel

  • Regional Institute of Oncology Iasi

    RECRUITING

    Iași, 700483, Romania

  • Renovatio Clinical - The Woodlands Research Center

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Semmelweis University, Department of Urology

    COMPLETED

    Budapest, Budapest, Hungary

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Israel, 5262000, Israel

  • St. John of Dukla Oncology Center of Lublin Land

    RECRUITING

    Lublin, 20-090, Poland

  • Texas Urology Specialists-Austin

    RECRUITING

    Austin, Texas, 78705, United States

  • The James Cancer Hospital and Solove Research Institute

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Texas Southwestern Medical Center

    COMPLETED

    Dallas, Texas, 75390, United States

  • The Urology Center, P.C.

    COMPLETED

    Omaha, Nebraska, 68114, United States

  • Timisoara County Clinical Emergency Hospital Pius Brinzeu

    RECRUITING

    Timișoara, 300723, Romania

  • UC Irvine Health. Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

  • UPNT Research Institute, LLC

    RECRUITING

    Arlington, Texas, 76017, United States

  • USA Operation d/b/a US Clinical Trials

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University Clinical Center in Gdansk, Department of urology

    COMPLETED

    Gdansk, Pomeranian, Poland

  • University Hospital Clinical San Carlos, Department of Urology

    RECRUITING

    Madrid, Madrid, 28040, Spain

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

    RECRUITING

    A Coruña, Galicia, Spain

  • University Hospital Ramon y Cajal

    RECRUITING

    Madrid, Madrid, Spain

  • University Hospital de La Princesa

    RECRUITING

    Madrid, Madrid, 28006, Spain

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

    RECRUITING

    Plovdiv, Plovdiv, 4002, Bulgaria

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

    RECRUITING

    Sofia, 1000, Bulgaria

  • University of Arkansas for Medical Sciences

    RECRUITING

    Arkansas City, Arkansas, 72205, United States

  • University of Cincinnati Medical Center (UCMC)

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Debrecen Clinical Center, Department of Urology

    RECRUITING

    Debrecen, 4032, Hungary

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

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Rochester Medical Center

    NOT_YET_RECRUITING

    Rochester, New York, 14642, United States

  • University of Virginia Comprehensive Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Urologic Specialists of Oklahoma

    RECRUITING

    Tulsa, Oklahoma, 74146-5830, United States

  • Urology Center of Iowa Research

    RECRUITING

    Clive, Iowa, 50325, United States

  • Urology Centers of Alabama

    RECRUITING

    Homewood, Alabama, 35209, United States

  • Urology Specialists of the Carolinas - Greensboro

    RECRUITING

    Greensboro, North Carolina, 27403, United States

  • Urology Specialists of the Carolinas, PLLC

    RECRUITING

    Charlotte, North Carolina, 28204, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.