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

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514360-70-00

Acronym

000425

Enrollment

Registered

2025-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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)

Interventions

DRUGADSTILADRIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

—

Countries

France, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026