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)
Фаза 2 – изследване на ефективността и дозировката
Trial status: Authorised
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)
Кой може да участва
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 5 participants
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