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Active, not recruiting Phase 1Phase 2 Interventional

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

ClinicalTrials.gov ID: NCT05316155

Public ClinicalTrials.gov record NCT05316155. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT05316155
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
235 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 10, 2022
Primary completion
Mar 29, 2028
Completion
Jul 23, 2029
Last update posted
Aug 27, 2026

2022 – 2029

United States locations

U.S. sites
25
U.S. states
17
U.S. cities
25
Facility City State ZIP Site status
University of Alabama at Birmingham - The Kirklin Clinic Birmingham Alabama 35294
University of Southern California Los Angeles California 90033
Urology Associates of Denver Lone Tree Colorado 80124
Urological Research Network Hialeah Florida 33016
Advanced Urology Institute Largo Florida 33771
Advent Health Orlando Orlando Florida 32804
Advanced Urology Institute 1 Oxford Florida 34484
H Lee Moffitt Cancer Center Tampa Florida 33612
Northwestern University Chicago Illinois 60611
Associated Urological Specialists Chicago Ridge Illinois 60415
Urology of Indiana Greenwood Indiana 46143
Urologic Specialists of Northwest Indiana Merrillville Indiana 46410
University of Kentucky Lexington Kentucky 40506
Southern Urology LLC Lafayette Louisiana 70508
Greater Boston Urology Plymouth Massachusetts 02360
Specialty Clinical Research of St Louis St Louis Missouri 63141
Hackensack University Medical Center Urology Hackensack New Jersey 07601
Associated Medical Professionals Syracuse New York 13210
Levine Cancer Institute, Carolinas HealthCare System Charlotte North Carolina 28204
Central Ohio Urology Group Gahanna Ohio 43230
Carolina Urologic Research Center Myrtle Beach South Carolina 29572
Low Country Urology Clinics North Charleston South Carolina 29406
Urology Associates Nashville Tennessee 37209
Urology Austin Austin Texas 78745
Urology San Antonio Research San Antonio Texas 78229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05316155, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05316155 live on ClinicalTrials.gov.

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