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Study identifier: NCT05316155 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Condition: Non-Muscle Invasive Bladder Neoplasms  ·  Sponsor: Janssen Research & Development, LLC

PhasePhase 1/Phase 2
Planned participants235
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Study Contact  ·  844-434-4210  ·  Participate-In-This-Study1@its.jnj.com

Always discuss trial participation with your own doctor first.

Locations (59)

University of Alabama at Birmingham - The Kirklin ClinicBirmingham, Alabama, United StatesRecruiting
University of Southern CaliforniaLos Angeles, California, United StatesRecruiting
Urology Associates of DenverLone Tree, Colorado, United StatesRecruiting
Urological Research NetworkHialeah, Florida, United StatesRecruiting
Advanced Urology InstituteLargo, Florida, United StatesRecruiting
Advent Health OrlandoOrlando, Florida, United StatesCompleted
Advanced Urology Institute 1Oxford, Florida, United StatesCompleted
H Lee Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
Northwestern UniversityChicago, Illinois, United StatesRecruiting
Associated Urological SpecialistsChicago Ridge, Illinois, United StatesRecruiting
Urology of IndianaGreenwood, Indiana, United StatesRecruiting
Urologic Specialists of Northwest IndianaMerrillville, Indiana, United StatesRecruiting

+ 47 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05316155