Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- 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 Severity — Up 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.
Trial sites (59)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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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 Japan