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Study of Erdafitinib Intravesical Delivery System for Bladder Cancer

This study is testing a new way to deliver Erdafitinib, a drug that targets specific genetic changes, directly into the bladder for people with localized bladder cancer. The treatment is called the Erdafitinib Intravesical Delivery System. Researchers want to find the best dose and see how well it works, while also checking for side effects. You might be able to join if you have non-muscle invasive or muscle-invasive bladder cancer and your tumor has certain genetic changes called FGFR mutations or fusions. The main goal is to see how many people experience side effects and how severe they are. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 235 participants. It has multiple parts to determine the best dose and then confirm its safety and effectiveness.
What's involved
The study involves a screening phase, a treatment phase, and a follow-up phase. The total duration of the study is approximately up to 7 years and 4 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for up to approximately 7 years and 4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05316155

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~235 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Erdafitinib Intravesical Delivery System

At a glance

Recruiting sites
0 of 59 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts 1 to 3: Number of Participants with Adverse Events (AEs)
Measured over Up to approximately 7 years 4 months
+3 more outcomes measured

Conditions

Non-Muscle Invasive Bladder Neoplasms

Explore related trials

Bladder CarcinomaNon-Muscle Invasive Bladder Carcinoma

NCT05316155

Where you'd take part

This study runs at 59 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advanced Urology Institute

    Largo, Floridano site contact published

  • Advanced Urology Institute 1

    Oxford, Floridano site contact published

  • Advent Health Orlando

    Orlando, Floridano site contact published

  • Associated Medical Professionals

    Syracuse, New Yorkno site contact published

  • Associated Urological Specialists

    Chicago Ridge, Illinoisno site contact published

  • Carmel Medical Center

    Haifa, Israelno site contact published

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolinano site contact published

  • Central Ohio Urology Group

    Gahanna, Ohiono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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
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

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
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

What this trial measures

  • Parts 1 to 3: Number of Participants with Adverse Events (AEs)Up to approximately 7 years 4 months

    An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  • Parts 1 to 3: Number of Participants with AEs by SeverityUp to approximately 7 years 4 months

    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

  • Part 1: Number of Participants with Dose-limiting Toxicity (DLT)Up to 28 days

    Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

  • Part 4: Overall Complete Response (CR) in Participants with Intermediate Risk-Non-Muscle Invasive Bladder Cancer (IR-NMIBC)Up to approximately 7 years 4 months

    Overall CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy.