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)

Condition studied

Low-grade upper track urothelial carcinoma (LG-UTUC)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Primary Safety Endpoint: The number of treatment-emergent adverse events reported by each subject during the trial., Primary Efficacy Endpoint: Complete response at 3 or 6 months defined as absence of any UTUC in the renal pelvis, i.e. negative urine cytology for high-grade urothelial carcinoma (centrally assessed), and either no suspicious lesions on ureteroscopy (investigator assessed) or a negative for-cause biopsy (centrally assessed)