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)
Ferring Pharmaceuticals
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Aged ≥18 years at the time of signing informed consent. 2. Able to give written informed consent. 3. Have biopsy-proven low-grade upper tract urothelial cancer (LG-UTUC) confirmed by a pathology report ≤2 months prior to enrolment. 4. Have ≥1 measurable papillary low-grade tumour (5-15 mm in maximum diameter), evaluated visually above the ureteropelvic junction before enrolment. * Subjects with low-grade tumour larger than 15 mm will be eligible if endoscopic downsizing of the tumour to 5-15 mm in maximum diameter has been performed before enrolment. 5. Willing to b…
Interventions
- DrugNadofaragene Firadenovec
Repeat dose trial to investigate the safety and efficacy of nadofaragene firadenovec instilled into the renal pelvis
Locations (9)
- Mayo Clinic - Scottsdale ArizonaScottsdale, Arizona
- Providence Saint John's Cancer InstituteSanta Monica, California
- Mayo ClinicJacksonville, Florida
- Indiana UniversityIndianapolis, Indiana
- Mayo Clinic - Rochester MinnesotaRochester, Minnesota
- Memorial Sloan Kettering Cancer CenterNew York, New York