New bladder cancer drug delivered straight to the tumor shows promise in early trial

NCT ID NCT05316155

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

First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 37 times

Summary

This study tests a drug called erdafitinib, which is placed directly into the bladder using a special delivery system. The goal is to find the best dose and see if it can shrink or control bladder cancer that hasn't spread deeply into the bladder wall. About 235 people with non-muscle-invasive or muscle-invasive bladder cancer will take part. The trial is currently recruiting.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Advanced Urology Institute
RECRUITING

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

Oxford, Florida, 34484, United States
Advent Health Orlando
COMPLETED

Orlando, Florida, 32804, United States
Associated Medical Professionals
RECRUITING

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

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

Haifa, 3436212, Israel
Carolina Urologic Research Center
RECRUITING

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

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

Gwangju, 61469, South Korea
Fund. Puigvert
COMPLETED

Barcelona, 08025, Spain
Greater Boston Urology
RECRUITING

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

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

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

Barcelona, 08036, Spain
Hosp Reina Sofia
ACTIVE_NOT_RECRUITING

Córdoba, 14004, Spain
Hosp Univ Fund Jimenez Diaz
ACTIVE_NOT_RECRUITING

Madrid, 28040, Spain
Hosp Univ Vall D Hebron
ACTIVE_NOT_RECRUITING

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

Madrid, 28041, Spain
Hosp. Univ. La Paz
ACTIVE_NOT_RECRUITING

Madrid, 28046, Spain
Instituto Valenciano de Oncologia
ACTIVE_NOT_RECRUITING

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

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

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

Herne, 44625, Germany
National Cancer Center
COMPLETED

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

Fukuoka, 810 8563, Japan
Northwestern University
RECRUITING

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

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

Osaka, 558-8558, Japan
Princess Margaret Cancer Centre
COMPLETED

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

Petah Tikva, 4941492, Israel
Radboud Umcn
COMPLETED

Nijmegen, 6525 GA, Netherlands
Rambam Medical Center
ACTIVE_NOT_RECRUITING

Haifa, 3109601, Israel
Seoul National University Hospital
ACTIVE_NOT_RECRUITING

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

Seoul, 03722, South Korea
Southern Urology LLC
RECRUITING

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

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

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

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

Seoul, 06591, South Korea
Toyama University Hospital
ACTIVE_NOT_RECRUITING

Toyama, 930 0194, Japan
UMC Utrecht
COMPLETED

Utrecht, 3584 CX, Netherlands
Universitaetsklinikum Ulm
COMPLETED

Ulm, 89081, Germany
Universitatsklinikum Carl Gustav Carus Dresden
COMPLETED

Dresden, 01307, Germany
Universitatsklinikum Frankfurt
ACTIVE_NOT_RECRUITING

Frankfurt am Main, 60590, Germany
Universitatsklinikum Munster
COMPLETED

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

Birmingham, Alabama, 35294, United States
University of Kentucky
RECRUITING

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

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

Merrillville, Indiana, 46410, United States
Urological Research Network
RECRUITING

Hialeah, Florida, 33016, United States
Urologicum Duisburg
COMPLETED

Duisburg, 47169, Germany
Urologie Neandertal Praxis Mettmann
ACTIVE_NOT_RECRUITING

Mettmann, 40822, Germany
Urology Associates
RECRUITING

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

Lone Tree, Colorado, 80124, United States
Urology Austin
RECRUITING

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

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

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

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

Kofu, 400-8506, Japan

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 treatment option for bladder cancer that delivers the drug directly to the tumor, potentially reducing side effects and improving outcomes.

What could go wrong

This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or safe. Side effects are possible, and the approach may not work for all types of bladder cancer.

Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms 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 NON-MUSCLE INVASIVE BLADDER NEOPLASMS RECEPTORS, FIBROBLAST GROWTH FACTOR URINARY BLADDER NEOPLASMS