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Clinical Trials | UT002: 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)

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)

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with low-grade upper tract urothelial cancer (LG-UTUC). The purpose of this study is to test a new investigational version of a treatment called UGN-104 for people with LG-UTUC. UGN-104 is a reformulated version of a drug called JELMYTO (UGN-101), which was approved by the FDA in 2020 to treat this type of cancer. The goal of this study is to see if UGN-104 works as well and is as safe as UGN-101. The study will compare how UGN-104 performs to previous studies using UGN-101. In this study, you will undergo a Screening Visit to determine eligibility. Eligible patients will be treated with UGN-104 once weekly for 6 weeks (a total of 6 doses). Every effort will be made to ensure = 50% of patients receive UGN-104 via antegrade administration. You will complete screening visit, treatment visits, primary disease evaluation visit and follow-up visits. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. The total duration of study participation for each patient (from first instillation to last visit) is up to 15 months. Additional information found here: https://www.clinicaltrials.gov/study/NCT06774131 For questions, contact: [email protected]