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)
Objective
Primary: To evaluate the tumor ablative effect of UGN-104, a novel formulation of UGN-101, in patients with LG-UTUC.
Secondary: To evaluate the durability of response with respect to DOR and DCR rate at scheduled disease assessment time points. To evaluate the safety and tolerability of UGN-104 in patients with LG-UTUC. To assess the PK profile of mitomycin in plasma in a subgroup of patients treated with UGN-104.
Exploratory To assess the effect of UGN-104 on PRO measures including quality of life, treatment satisfaction, and PGI-C.
