Study of UGN-104 (mitomycin) treatment for patients with low-grade upper tract urothelial cancer

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What is this study about?

This clinical trial focuses on patients with Low-grade Upper Tract Urothelial Cancer, a type of cancer that develops in the lining of the kidney’s collecting system. The study will test a new medicine called UGN-104, which contains the active substance mitomycin. This treatment comes in the form of a powder that is mixed into a solution before use.

The purpose of this research is to evaluate how effective UGN-104 is at removing tumors in patients with this type of cancer. The medication will be given directly into the upper urinary tract through a procedure called intravesical administration. Each patient will receive six treatments of the medicine over a treatment period that can last up to 12 months.

After completing the treatment, patients will have a check-up approximately 5 weeks after their final dose to determine if the treatment was successful in eliminating the cancer. The study will continue to monitor patients to see how long the treatment effects last and to check for any side effects. Throughout the study, doctors will perform various tests to ensure patient safety, including blood tests and imaging of the urinary tract.

1 Initial assessment

Your medical team will perform a detailed evaluation to confirm low-grade upper tract urothelial cancer diagnosis

Laboratory tests will be conducted to check organ function and blood counts

A visual examination of tumors in the upper urinary tract will be performed

2 Treatment preparation

The medical team will ensure there is no active urinary tract infection before starting treatment

If infection is present, antibiotics will be prescribed and treatment will be delayed until resolved

3 Treatment administration

UGN-104 medication will be administered directly into the upper urinary tract

You will receive six treatments in total

The medication is a special powder form that is prepared for administration

4 Post-treatment evaluation

5 weeks (plus/minus 1 week) after the sixth treatment, a detailed examination will be performed

This examination includes: urine tests, visual examination of the urinary tract, and if needed, a tissue sample

The medical team will assess if the treatment has been effective in removing the cancer

5 Follow-up period

Regular check-ups will be scheduled to monitor your condition

Safety assessments will include blood tests, urine analysis, physical examinations, and vital signs monitoring

You will be asked to complete questionnaires about your health and treatment experience

6 Safety considerations

Male patients must use appropriate contraception for 48 hours after each treatment

All patients must use two forms of effective contraception during the study and for 6 months afterward

Regular monitoring of side effects and any health changes will continue throughout the study

Who Can Join the Study?

  • Must provide written informed consent and agree to follow study requirements
  • Must be 18 years or older
  • Must have low-grade, non-invasive upper tract urothelial cancer in the kidney collection system with:
    • At least 1 measurable tumor no larger than 15 millimeters
    • At least 1 tumor must be at least 5 millimeters in size after biopsy
    • Biopsy confirming low-grade cancer
    • Urine test showing no signs of high-grade cancer
  • Must have good physical function status (ECOG score less than 3, which means able to care for self but unable to work)
  • Must have life expectancy of more than 24 months
  • Must have adequate organ function shown by blood tests including:
    • Normal white blood cell counts
    • Normal platelet levels
    • Adequate hemoglobin levels
    • Normal liver function tests
    • Adequate kidney function
  • Must not have active urinary tract infection
  • Must agree to use effective birth control:
    • Both men and women must use two forms of birth control during study
    • Men must use condoms for 48 hours after each treatment
    • Birth control must continue for 6 months after treatment ends

Who Cannot Join the Study?

  • Age under 18 years old
  • Patients with high-grade urothelial cancer (more aggressive form of cancer in the urinary tract)
  • Previous treatment with chemotherapy or immunotherapy within the last 6 months
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Severe kidney dysfunction
  • Active urinary tract infection
  • Pregnant or breastfeeding women
  • History of allergic reactions to similar medications
  • Participation in another clinical trial within the last 30 days
  • Significant heart, liver, or other medical conditions that could interfere with study participation
  • Unable to follow study procedures or attend required visits
  • Current substance abuse or mental health conditions that could affect compliance

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Orszagos Onkologiai Intezet Budapest Hungary
Hospital Universitario Puerta Del Mar Cadiz Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Delta Health Care S.R.L. Bucharest Romania
Daugavpils regionala slimnica SIA Daugavpils Latvia
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Fundacio Puigvert Barcelona Spain
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Hospital Universitario Ramon Y Cajal Madrid Spain
University Of Debrecen Debrecen Hungary
Hospital Clinico Universitario De Valencia Valencia Spain
Spitalul Clinic Judetean De Urgenta Bihor Oradea Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Hospital Universitario Virgen Macarena Sevilla Spain
Hospital Universitario Reina Sofía Cordoba Spain
Institutul Regional De Oncologie Iasi Iasi Romania
Semmelweis University Budapest Hungary
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Araba Vitoria Spain
Multidisciplinary Hospital For Active Treatment Haskovo AD Haskovo Bulgaria
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Complex Oncological Center – Shumen EOOD Shumen Bulgaria
In Vivo Sp. z o.o. Bydgoszcz Poland
Liepajas Regionala Slimnica SIA Liepaja Latvia
Szpital Miejski Specjalistyczny Im. Gabriela Narutowicza W Krakowie Cracow Poland
Ssvwmsvc Cnhpil Dj Nxwsrklqhr Dzr Cwadl Dqhxxf Bucharest Romania
Meja Vkllj Eret Varna Bulgaria
Mheyxxukuyl Cjgnxom Rfmrxyoxiswlr &ghxkwkjhimmirrbtcvb Srjshqn Kurtqsiz w Prlcxwaivv Pruszkow Poland
Puvnujxvytmhlppz Wzkbpudwslpsk Jrkt Sar z okzj Katowice Poland
Eyy Ptbwqpqfe Sfa z oied Piaseczno Poland
Sxdtemgp Chhkqm Mxiofrvbx Ctcwcwzfqwg Cluj Napoca Romania
Sc Zfz Mrcprqlazhnw Sztlc Wtyyyurzzqje w Pngmwhaf iyg Pmbjb Lwshkis Bnynqhttltkxu Poznan Poland
Ucnfnftbxswhw Satrygz Kcatiurtj Nu 2 Pvt W Sbburmcglq Szczecin Poland
Rjdpf Aaqxxotm kilwadvj upwziuffuiugj sxrclxek Sms Riga Latvia
Uizgtekbdtusie Casabzy Kjwghhmoh Gdansk Poland
Hvpgotkf Ufcazyzlwgqbf dc A Cluoad A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
26.06.2025
Hungary Hungary
Recruiting
26.06.2025
Latvia Latvia
Not yet recruiting
26.06.2025
Poland Poland
Recruiting
26.06.2025
Romania Romania
Recruiting
26.06.2025
Spain Spain
Recruiting
26.06.2025

Trial locations

Investigated drugs:

UGN-104 is an investigational medication delivered directly to the upper urinary tract. It is a novel formulation of UGN-101, designed to treat low-grade upper tract urothelial cancer. This medication is applied locally to target cancer cells in the urinary system, specifically in the upper parts of the urinary tract. The medication is being studied as a potential treatment option that may help eliminate tumors in this specific area of the body.

Low-grade Upper Tract Urothelial Cancer – A rare form of cancer that develops in the lining of the upper urinary tract, specifically in the renal pelvis or ureter. This cancer begins in the urothelial cells (also called transitional cells) that line these structures. The term “low-grade” indicates that the cancer cells appear more similar to normal cells and tend to grow more slowly than high-grade cancers. The disease typically develops gradually, with cancer cells growing within the inner lining of the urinary tract. It can occur in one or multiple locations within the upper urinary system.

Trial ID:
2024-519343-15-00
Protocol code:
UT002
NCT ID:
NCT06774131
Trial Phase:
Therapeutic confirmatory (Phase III)

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