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

Source: https://onco.cc/trials/nct06774131/  
OnCo record `nct06774131` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing UGN-104 in bladder & urothelial cancer, now recruiting.

## Summary

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer is a phase 3 interventional study registered as NCT06774131, led by UroGen Pharma, and recruiting on the registry. 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). Planned enrolment is 70 participants (estimated). The study started in 2025-08-06 and primary completion is expected in 2027-03. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT06774131
- Phase: 3
- Setting: 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)
- Sponsor: UroGen Pharma
- Enrolled: 70

## Sources

- ClinicalTrials.gov NCT06774131: https://clinicaltrials.gov/study/NCT06774131

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- drugs: [UGN-104](https://onco.cc/drugs/ugn-104/)
- companies: [UroGen Pharma](https://onco.cc/companies/urogen-pharma/)

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