NCT06668493

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low-grade Upper Tract Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Nadofaragene Firadenovec	Repeat dose trial to investigate the safety and efficacy of nadofaragene firadenovec instilled into the renal pelvis

Timeline

• Start date: 2025-06-12
• Primary completion: 2029-11-30
• Completion: 2029-11-30
• First posted: 2024-10-31
• Last updated: 2026-02-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study