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Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion; MoonRISe-2) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).
Official title: Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
235
Start Date
2022-04-11
Completion Date
2029-07-24
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Erdafitinib Intravesical Delivery System
Erdafitinib intravesical delivery system will be administered.
Locations (59)
University of Alabama at Birmingham - The Kirklin Clinic
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
Urology Associates of Denver
Lone Tree, Colorado, United States
Urological Research Network
Hialeah, Florida, United States
Advanced Urology Institute
Largo, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Advanced Urology Institute
Oxford, Florida, United States
H Lee Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Associated Urological Specialists
Chicago Ridge, Illinois, United States
Urology of Indiana
Greenwood, Indiana, United States
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Southern Urology LLC
Lafayette, Louisiana, United States
Greater Boston Urology
Plymouth, Massachusetts, United States
Specialty Clinical Research of St Louis
St Louis, Missouri, United States
Hackensack University Medical Center Urology
Hackensack, New Jersey, United States
Associated Medical Professionals
Syracuse, New York, United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina, United States
Central Ohio Urology Group
Gahanna, Ohio, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Low Country Urology Clinics
North Charleston, South Carolina, United States
Urology Associates
Nashville, Tennessee, United States
Urology Austin
Austin, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Vancouver Prostate Centre Diamond Health Care Centre
Vancouver, British Columbia, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
St Josephs Healthcare Hamilton
Hamilton, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Urologicum Duisburg
Duisburg, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, Germany
Marien hospital Herne
Herne, Germany
Urologie Neandertal Praxis Mettmann
Mettmann, Germany
Universitatsklinikum Munster
Münster, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Rambam Medical Center
Haifa, Israel
Carmel Medical Center
Haifa, Israel
Rabin Medical Center
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
Yamanashi Prefectural Central Hospital
Kofu, Japan
Osaka General Medical Center
Osaka, Japan
Toyama University Hospital
Toyama, Japan
Radboud Umcn
Nijmegen, Netherlands
UMC Utrecht
Utrecht, Netherlands
National Cancer Center
Goyang-si, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea
Fund. Puigvert
Barcelona, Spain
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp Clinic de Barcelona
Barcelona, Spain
Hosp Reina Sofia
Córdoba, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp. Univ. La Paz
Madrid, Spain
Instituto Valenciano de Oncologia
Valencia, Spain