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.
Official 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)
Conditions
Low-grade Upper Tract Urothelial Carcinoma
Intervention / Treatment
Drug: Nadofaragene Firadenovec
Other Study ID Numbers
- 000425
- U1111-1
292-0846 (Other Identifier) (OTHER: World Health Organisation (WHO))
Learn more at: https://clinicaltrials.gov/study/NCT06668493