RecruitingPhase 1Phase 2NCT06668493

Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis

A Phase 1/2, Single-arm, Open-Label Trial to Evaluate the Safety and Efficacy of Nadofaragene Firadenovec Instilled to the Renal Pelvis in Adult Subjects With Low-grade Upper Tract Urothelial Carcinoma (LG-UTUC)


Sponsor

Ferring Pharmaceuticals

Enrollment

20 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this trial is to evaluate the safety \& tolerability of Nadofaragene Firadenovec in subjects with LG-UTUC. To help with this evaluation, a safety lead-in period will be conducted for the first 6 subjects. Complete response is at 3 or 6 months defined as absence of any UTUC in the renal pelvis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nadofaragene Firadenovec for people with low-grade upper tract urothelial carcinoma. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNadofaragene Firadenovec

Repeat dose trial to investigate the safety and efficacy of nadofaragene firadenovec instilled into the renal pelvis


Locations(9)

Mayo Clinic - Scottsdale Arizona

Scottsdale, Arizona, United States

Providence Saint John's Cancer Institute

Santa Monica, California, United States

Mayo Clinic

Jacksonville, Florida, United States

Indiana University

Indianapolis, Indiana, United States

Mayo Clinic - Rochester Minnesota

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology

Philadelphia, Pennsylvania, United States

Baylor College of Medicine (Houston)

Houston, Texas, United States

MD Anderson Cancer Center - Genitourinary (GU) Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06668493


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