Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Non-Muscle Invasive Bladder Neoplasms

In brief

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).

Key facts

Study ID: NCT05316155
Run by: Janssen Research & Development, LLC
People needed: 235
Starts: 2022-04-11
Expected to finish: 2029-07-24
Last updated by the study team: 2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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
University of Alabama at Birmingham - The Kirklin Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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