Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
NCT05316155 · View on ClinicalTrials.gov ↗
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).
Conditions Studied
Interventions
- DRUG Erdafitinib Intravesical Delivery System
Study Locations (20)
Florida
- Urological Research Network — Hialeah
- Advanced Urology Institute — Largo
- Advent Health Orlando — Orlando
- Advanced Urology Institute — Oxford
- H Lee Moffitt Cancer Center — Tampa
Illinois
- Northwestern University — Chicago
- Associated Urological Specialists — Chicago Ridge
Indiana
- Urology of Indiana — Greenwood
- Urologic Specialists of Northwest Indiana — Merrillville
Alabama
- University of Alabama at Birmingham - The Kirklin Clinic — Birmingham
California
- University of Southern California — Los Angeles
Colorado
- Urology Associates of Denver — Lone Tree
Kentucky
- University of Kentucky — Lexington
Louisiana
- Southern Urology LLC — Lafayette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2022-04-11 |
| Est. Completion | 2029-07-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05316155
The ClinicalTrials.gov registry entry for NCT05316155 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-Muscle Invasive Bladder Neoplasms appearing as the primary indexed condition, and to 1 intervention — of which Erdafitinib Intravesical Delivery System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05316155 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, Illinois, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05316155 about?
NCT05316155 is a clinical study titled "Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer". 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 expansio...
What is the current status of trial NCT05316155?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 235 participants. The study started on 2022-04-11. Estimated completion is 2029-07-24.
What conditions does trial NCT05316155 study?
This clinical trial studies the following conditions: Non-Muscle Invasive Bladder Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05316155?
The interventions under investigation include: Erdafitinib Intravesical Delivery System (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05316155?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05316155 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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