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NCT05316155 · ClinicalTrials.gov registry record · Phase 1

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

A Phase 1 study of Non-Muscle Invasive Bladder Neoplasms, sponsored by Janssen Research & Development.

Recruiting
Registry status
Phase 1
Development phase
235
Enrollment target
20
Study locations

NCT05316155 is a Phase 1 study of Non-Muscle Invasive Bladder Neoplasms that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 235 participants, below the 274-participant average among 6 other Non-Muscle Invasive Bladder Neoplasms trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05316155, a Phase 1 study of Non-Muscle Invasive Bladder Neoplasms, is actively recruiting participants, sponsored by Janssen Research & Development.

RECRUITING
Registry status
Phase 1
Development phase
235 participants
Enrollment target
20
Study locations

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

Non-Muscle Invasive Bladder Neoplasms

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

FieldValue
Enrollment Target 235 participants
Start Date 2022-04-11
Est. Completion 2029-07-24
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

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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, categorized as Phase 1. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 274-participant average among 6 other Non-Muscle Invasive Bladder Neoplasms trials with a reported enrollment target (14% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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.

NCT05316155 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, Illinois, Indiana.

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.

What interventions are being tested in trial NCT05316155?

The interventions under investigation include: Erdafitinib Intravesical Delivery System (DRUG).

Who is sponsoring clinical trial NCT05316155?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.