RecruitingPhase 1Phase 2NCT05316155

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer

Sponsor

Janssen Research & Development, LLC

Enrollment

235 participants

Start Date

Apr 11, 2022

Study Type

INTERVENTIONAL

Conditions

Non-Muscle Invasive Bladder Neoplasms

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an experimental bladder-instilled (delivered directly into the bladder) formulation of erdafitinib — a targeted drug that blocks FGFR mutations — for people with localized bladder cancer. By delivering the drug directly into the bladder, researchers hope to treat the tumor while reducing the side effects that come with systemic (whole-body) treatment. **You may be eligible if...** - You have muscle-invasive or recurrent non-muscle-invasive bladder cancer (urothelial carcinoma) - For certain study cohorts, your tumor must have a specific FGFR mutation or fusion, confirmed by approved genetic testing - You are medically fit to undergo the intravesical treatment procedure **You may NOT be eligible if...** - You do not have the required FGFR mutation (for mutation-specific cohorts) - You have had prior treatment that conflicts with study requirements - You have severe bladder or urinary tract conditions that prevent the instillation procedure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGErdafitinib 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 1

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

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NCT05316155

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