New bladder cancer treatment delivers drug straight to the tumor

NCT ID NCT05316155

Ongoing Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a drug called erdafitinib, placed directly into the bladder using a special delivery system, for people with non-muscle-invasive or muscle-invasive bladder cancer. The trial has four parts to find the best dose and check safety and effectiveness. About 235 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Erdafitinib (a targeted cancer drug delivered directly into the bladder via a special system)
What this could lead to: If successful, this could offer a new, targeted treatment option for bladder cancer that may reduce the need for more invasive procedures.
What could go wrong: This is an early-phase trial (Phase 1/2) testing safety and dosing, so it is not yet proven to work. Side effects from the drug or delivery system are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma urinary bladder neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NON-MUSCLE INVASIVE BLADDER NEOPLASMS RECEPTORS, FIBROBLAST GROWTH FACTOR URINARY BLADDER NEOPLASMS

Contacts and locations

Locations

Advanced Urology Institute

Largo, Florida, 33771, United States
Advanced Urology Institute 1

Oxford, Florida, 34484, United States
Advent Health Orlando

Orlando, Florida, 32804, United States
Associated Medical Professionals

Syracuse, New York, 13210, United States
Associated Urological Specialists

Chicago Ridge, Illinois, 60415, United States
Carmel Medical Center

Haifa, 3436212, Israel
Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States
Central Ohio Urology Group

Gahanna, Ohio, 43230, United States
Chonnam National University Hospital

Gwangju, 61469, South Korea
Fund. Puigvert

Barcelona, 08025, Spain
Greater Boston Urology

Plymouth, Massachusetts, 02360, United States
H Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States
Hackensack University Medical Center Urology

Hackensack, New Jersey, 07601, United States
Hosp Clinic de Barcelona

Barcelona, 08036, Spain
Hosp Reina Sofia

Córdoba, 14004, Spain
Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain
Hosp Univ Vall D Hebron

Barcelona, 08035, Spain
Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain
Hosp. Univ. La Paz

Madrid, 28046, Spain
Instituto Valenciano de Oncologia

Valencia, 46009, Spain
Levine Cancer Institute, Carolinas HealthCare System

Charlotte, North Carolina, 28204, United States
Low Country Urology Clinics

North Charleston, South Carolina, 29406, United States
Marien hospital Herne

Herne, 44625, Germany
National Cancer Center

Goyang-si, 10408, South Korea
National Hospital Organization Kyushu Medical Center

Fukuoka, 810 8563, Japan
Northwestern University

Chicago, Illinois, 60611, United States
Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada
Osaka General Medical Center

Osaka, 558-8558, Japan
Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada
Rabin Medical Center

Petah Tikva, 4941492, Israel
Radboud Umcn

Nijmegen, 6525 GA, Netherlands
Rambam Medical Center

Haifa, 3109601, Israel
Seoul National University Hospital

Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea
Southern Urology LLC

Lafayette, Louisiana, 70508, United States
Specialty Clinical Research of St Louis

St Louis, Missouri, 63141, United States
St Josephs Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada
Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel
The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea
Toyama University Hospital

Toyama, 930 0194, Japan
UMC Utrecht

Utrecht, 3584 CX, Netherlands
Universitaetsklinikum Ulm

Ulm, 89081, Germany
Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany
Universitatsklinikum Frankfurt

Frankfurt am Main, 60590, Germany
Universitatsklinikum Munster

Münster, 48149, Germany
University of Alabama at Birmingham - The Kirklin Clinic

Birmingham, Alabama, 35294, United States
University of Kentucky

Lexington, Kentucky, 40506, United States
University of Southern California

Los Angeles, California, 90033, United States
Urologic Specialists of Northwest Indiana

Merrillville, Indiana, 46410, United States
Urological Research Network

Hialeah, Florida, 33016, United States
Urologicum Duisburg

Duisburg, 47169, Germany
Urologie Neandertal Praxis Mettmann

Mettmann, 40822, Germany
Urology Associates

Nashville, Tennessee, 37209, United States
Urology Associates of Denver

Lone Tree, Colorado, 80124, United States
Urology Austin

Austin, Texas, 78745, United States
Urology San Antonio Research

San Antonio, Texas, 78229, United States
Urology of Indiana

Greenwood, Indiana, 46143, United States
Vancouver Prostate Centre Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada
Yamanashi Prefectural Central Hospital

Kofu, 400-8506, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.