LUNAR
Research type
Research Study
Full title
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)
IRAS ID
1011733
Contact name
Jean-Pierre Mahieu
Contact email
Sponsor organisation
Ferring Pharmaceuticals
Clinicaltrials.gov Identifier
Research summary
This study is investigating the study drug nadofaragene firadenovec as a possible treatment for low-grade upper urinary tract urothelial carcinoma (UTUC). The purpose of this study is to learn about how effective and well tolerated a gene therapy called nadofaragene firadenovec in patients with UTUC. The study drug, nadofaragene firadenovec, was approved under the brand name ADSTILADRIN for treatment of another type of cancer in the urinary tract (non-muscle invasive bladder cancer). As UTUC and the non-muscle invasive bladder cancer type display several similarities, it is expected to potentially see an effect of the study drug also in patients with UTUC.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0140
Date of REC Opinion
20 Jun 2025
REC opinion
Further Information Unfavourable Opinion