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

PHASE3RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 2, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2027

Conditions
Upper Urinary Tract Urothelial CarcinomaUrothelial Carcinoma
Interventions
DRUG

UGN-104

UGN-104 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-104 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the UUT.

Trial Locations (3)

17033

NOT_YET_RECRUITING

Penn State Milton S Hershey Medical Center, Hershey

33013

RECRUITING

BioResearch Partners Hialeah, Hialeah

33180

RECRUITING

BioResearch Partners Aventura, Aventura

All Listed Sponsors
lead

UroGen Pharma Ltd.

INDUSTRY

NCT06774131 - A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer | Biotech Hunter | Biotech Hunter