NCT05375903 - A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) | Biotech Hunter

Enrollment

51

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions

Non-muscle Invasive Bladder CancerNMIBCCarcinoma in Situ of BladderBladder CancerUrothelial Carcinoma BladderUrothelial Carcinoma Recurrent

Interventions

DRUG

UGN-301

"Induction Period: Intravesical administration once weekly for 6 weeks.~Optional Maintenance Period: Intravesical administration once every 3 months (at 6, 9, and 12 months after the start of treatment)."

DRUG

UGN-201

"Induction Period: Intravesical administration once weekly for 6 weeks.~Optional Maintenance Period: Intravesical administration once every 3 months (at 6, 9, and 12 months after the start of treatment)."

DRUG

Gemcitabine

"Induction Period: Intravesical administration once weekly for 6 weeks.~Optional Maintenance Period: Intravesical administration once every 3 months (at 6, 9, and 12 months after the start of treatment)."

Trial Locations (13)

10016

Manhattan Medical Research, New York

17033

Penn State Milton S Hershey Medical Center, Hershey

21287

Johns Hopkins University, Baltimore

28223

NEXT Oncology- Hospital Quironsalud Mardrid, Madrid

33615

Florida Urology Partners, LLC, Tampa

44130

Clinical Research Solutions, Middleburg Heights

72211

Arkansas Urology, Little Rock

90095

UCLA - University of California, Los Angeles

Unknown

I.R.C.C.S. Ospedale San Raffaele, Milan

National Tumor Institute Fondazione G. Pascale, Naples

Istituto Oncologico Veneto, Padua

08023

NEXT Oncology IOB- Hospital Quironsalud Barcelona, Barcelona

08036

Hospital Clinic de Barcelona Instituto Clinic de Nefrologia y Urologia (ICNU), Barcelona