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New bladder cancer drug shows promise in Late-Stage trial

NCT ID NCT06331299

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug, UGN-103, given directly into the bladder for people with a low-grade, non-invasive bladder cancer that has a medium risk of coming back. The main goal is to see if the drug can make tumors disappear completely after 3 months. Researchers will also track how long the effect lasts and monitor safety. About 99 adults with this type of bladder cancer are taking part.

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

99 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Sep 2026

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 (ICF) and the protocol. 2. Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening. 3. History of at least 1 prior episode of NMIBC. Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened. 4. Has intermediate-risk disease, defined as having 1 or 2 of the following: * Presence of multiple tumors. * Solitary tumor \> 3 cm. * Early or frequent recurrence (≥ 1 occurrence of LG-NMIBC within 1 year of the current diagnosis at the initial Screening Visit). 5. Negative voiding cytology for high-grade (HG) disease within 8 weeks before Screening. 6. Has adequate organ and bone marrow function as determined by routine laboratory tests: * Leukocytes ≥ 3,000/μL. * Absolute neutrophil count ≥ 1,500/μL. * Platelets ≥ 100,000/μL. * 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 (ALP) ≤ 2.5 × ULN. * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min. 7. Has an anticipated life expectancy of at least the duration of the trial. 8. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment. Exclusion Criteria: 1. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within the previous 1 year. 2. History of HG bladder cancer (papillary or carcinoma in situ) in the past 2 years. 3. Known allergy or sensitivity to any component of the study treatment (including excipients) that in the investigator's opinion cannot be readily managed. 4. Clinically significant urethral stricture that would preclude passage of a urethral catheter. 5. History of: * Neurogenic bladder. * Active urinary retention. * Any other condition that would prohibit normal voiding. 6. Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC. 7. Current tumor stage of T1. 8. Concurrent upper tract urothelial carcinoma (UTUC). 9. Evidence of active urinary tract infection (UTI) that in the investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment. 10. Is pregnant or breastfeeding. 11. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol. 12. History of prior treatment with an intravesical chemotherapeutic agent in the past 2 years except for a single dose of chemotherapy immediately after any previous transurethral resection of bladder tumors (TURBT). 13. Has participated in a study with an investigational agent or device within 30 days of enrollment. 14. Has previously participated in a study in which they received UGN-102. 15. Has any other active malignancy requiring treatment with systemic anticancer therapy (eg, chemotherapy, immunotherapy, radiation therapy). Superficial cancers such as cutaneous basal cell or squamous cell carcinomas that can be treated locally are allowed. 16. Has any other clinically significant medical or surgical condition that in the investigator's opinion could compromise patient safety or the interpretation of study results. 17. 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.

bladder transitional cell carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms transitional cell carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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

Bladder cancer Urothelial carcinoma Urothelial carcinoma bladder

Contacts and locations

Locations

  • "Prof. Dr. Th. Burghele" Clinical Hospital, Department of Urology III

    Bucharest, 050659, Romania

  • AccuMed Research Associates

    Garden City, New York, 11530, United States

  • Bihor County Emergency Clinical Hospital

    Oradea, Bihor County, 410169, Romania

  • Brasov County Emergency Clinical Hospital, Department of Urology

    Brasov, Brașov County, 500157, Romania

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Colentina Clinical Hospital, Department of Urology

    Bucharest, 020125, Romania

  • Craiova County Emergency Clinical Hospital, Department of Urology

    Craiova, Dolj, 200642, Romania

  • Crystal Run Healthcare

    Middletown, New York, 10941, United States

  • Daugavpils Regional Hospital, Urology Department

    Daugavpils, LV-5417, Latvia

  • East Viru Central Hospital, Surgery Clinic

    Kohtla-Järve, Ida-Virumaa, 31025, Estonia

  • Garden State Urology

    Morristown, New Jersey, 07962, United States

  • Genesis Research, LLC

    San Diego, California, 92123, United States

  • Geo Hospitals LLC

    Tbilisi, 0144, Georgia

  • Great Lakes Physician dba WNYU

    Cheektowaga, New York, 14225, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Houston Metro Urology (HMU) - Southwest Location

    Houston, Texas, 77027, United States

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • JSC Jerarsi

    Tbilisi, 0167, Georgia

  • LLC "Todua Clinic"

    Tbilisi, 0119, Georgia

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

    Riga, LV-1079, Latvia

  • LTD MMT Hospital

    Tbilisi, 0159, Georgia

  • La Paz University Hospital

    Madrid, Madrid, 28046, Spain

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • Liepajas Regional Hospital, Urology Department

    Liepāja, LV-3414, Latvia

  • Loma Linda University Medical Center

    Loma Linda, California, 92354, United States

  • Minnesota Urology - Metro Urology - Woodbury

    Woodbury, Minnesota, 55125, United States

  • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology

    Gabrovo, Gabrovo, 5300, Bulgaria

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

    Shumen, Shumen Province, 9700, Bulgaria

  • North Estonia Medical Centre Foundation Ltd.

    Tallinn, Harju, 13419, Estonia

  • P. Stradins Clinical University Hospital, Center for Urology

    Riga, LV-1002, Latvia

  • Peachtree Clinical Solutions

    Powder Springs, Georgia, 30127, United States

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    New York, New York, 11501, United States

  • Puigvert Foundation

    Barcelona, Catalonia, 08025, Spain

  • SC Clinica Polisano Hospital

    Sibiu, Sibiu County, 550253, Romania

  • Spokane Urology, P.S.

    Spokane, Washington, 99202, United States

  • Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation

    Tartu, Tartu County, 50406, Estonia

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

    Tbilisi, 0144, Georgia

  • The George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037, United States

  • University Hospital 12 de Octubre

    Madrid, Madrid, 28041, Spain

  • University Hospital Foundation Jimenez Diaz

    Madrid, Madrid, 28040, Spain

  • University Hospital Virgen de la Victoria

    Málaga, Andalusia, 29010, Spain

  • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic

    Pleven, Pleven Province, 5800, Bulgaria

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

    Plovdiv, Plovdiv Province, 4002, Bulgaria

  • University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology

    Rousse, Ruse Province, 7000, Bulgaria

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

    Sofia, Sofia-Grad, 1606, Bulgaria

  • University Multiprofile Hospital for Active Treatment, Plovdiv, Clinic of Urology

    Plovdiv, Plovdiv Province, 4003, Bulgaria

  • Urology Associates P.C. - Nashville

    Nashville, Tennessee, 37209-4035, United States

  • West Tallinn Central Hospital Ltd., Department of Urology

    Tallinn, Harju, 10617, Estonia

More trials for these conditions

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