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New bladder cancer treatment delivers drug straight to the tumor

NCT ID NCT05316155

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 3 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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

235 people

The number who actually took part.

Started

Apr 2022

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Parts 1-3: * Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder * For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests * Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible * Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC) * Cohorts 2 and 4: Willing and eligible for RC Part 4: * Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors * Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5 millimeter (mm) in size * Must submit tissue and urine for FGFR testing * Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment Exclusion Criteria: Parts 1-3: * Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium * Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor * Received pelvic radiotherapy \<=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (\>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis * Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system * Indwelling urinary catheter. Intermittent catheterization is acceptable Part 4: * Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG/G2 or HG/G3 or CIS) or MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrollment. Previous high grade (HG) disease is accepted as long as diagnosis date is greater than or equal to (\>=5) years ago and there is documentation of low grade (LG) Ta thereafter * Known allergies, hypersensitivity, or intolerance to any study component or its excipients * Has a current diagnosis of newly diagnosed IR-NMIBC * Received an investigational treatment for bladder cancer after Transurethral Resection of the Bladder Tumor (TURBT) for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study * Evidence of current bladder perforation by cystoscopy or imaging

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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.