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Clinical Trials in Canada / NCT05316155
Active, not recruiting Phase 1/2

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

NCT05316155 · tracked via the Priya Life Science Canada tracker
Phase
Phase 1/2
Started
2022-04-11
Last updated
2026-09-25

Condition(s) studied

Non-Muscle Invasive Bladder Neoplasms

Investigational drug(s) / intervention(s)

Erdafitinib Intravesical Delivery System →

Erdafitinib Intravesical Delivery System: Erdafitinib intravesical delivery system will be administered.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
University of Alabama at Birmingham - The Kirklin Clinic Birmingham Alabama
University of Southern California Los Angeles California
Urology Associates of Denver Lone Tree Colorado
Urological Research Network Hialeah Florida
Advanced Urology Institute Largo Florida
Advent Health Orlando Orlando Florida
Advanced Urology Institute 1 Oxford Florida
H Lee Moffitt Cancer Center Tampa Florida
Northwestern University Chicago Illinois
Associated Urological Specialists Chicago Ridge Illinois
Urology of Indiana Greenwood Indiana
Urologic Specialists of Northwest Indiana Merrillville Indiana
University of Kentucky Lexington Kentucky
Southern Urology LLC Lafayette Louisiana
Greater Boston Urology Plymouth Massachusetts
Specialty Clinical Research of St Louis St Louis Missouri
Hackensack University Medical Center Urology Hackensack New Jersey
Associated Medical Professionals Syracuse New York
Levine Cancer Institute, Carolinas HealthCare System Charlotte North Carolina
Central Ohio Urology Group Gahanna Ohio
Carolina Urologic Research Center Myrtle Beach South Carolina
Low Country Urology Clinics North Charleston South Carolina
Urology Associates Nashville Tennessee
Urology Austin Austin Texas
Urology San Antonio Research San Antonio Texas
Vancouver Prostate Centre Diamond Health Care Centre Vancouver British Columbia
Nova Scotia Health Authority Halifax Nova Scotia
St Josephs Healthcare Hamilton Hamilton Ontario
Princess Margaret Cancer Centre Toronto Ontario
Universitatsklinikum Carl Gustav Carus Dresden Dresden Germany
Urologicum Duisburg Duisburg Germany
Universitatsklinikum Frankfurt Frankfurt am Main Germany
Marien hospital Herne Herne Germany
Urologie Neandertal Praxis Mettmann Mettmann Germany
Universitatsklinikum Munster Münster Germany
Universitaetsklinikum Ulm Ulm Germany
Rambam Medical Center Haifa Israel
Carmel Medical Center Haifa Israel
Rabin Medical Center Petah Tikva Israel
Tel Aviv Sourasky Medical Center Tel Aviv Israel

+ 19 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05316155 on ClinicalTrials.gov ↗ ← All trials in Canada