Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis

Conditions

• Low-grade Upper Tract Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nadofaragene Firadenovec — DRUG
  Repeat dose trial to investigate the safety and efficacy of nadofaragene firadenovec instilled into the renal pelvis

Study Details

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.

Key Dates

Start date

Jun 12, 2025

Status verified

Jul 2025

Primary completion

Nov 30, 2029

Completion

Nov 30, 2029

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment

Primary Outcome Measure

The number of treatment-emergent adverse events reported by each subject during the trial. [ Time Frame: Up to 30 months ]

Central Contacts

• Ferring Pharmaceuticals
  1-888-337-7464
  [email protected]

Locations (9)

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