Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFerring Pharmaceuticals
About this trial
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 criteria
Qualifiers
Aged ≥18 years at the time of signing informed consent.
Able to give written informed consent.
Have biopsy-proven low-grade upper tract urothelial cancer (LG-UTUC) confirmed by a pathology report ≤2 months prior to enrolment.
Have ≥1 measurable papillary low-grade tumour (5-15 mm in maximum diameter), evaluated visually above the ureteropelvic junction before enrolment.
Disqualifiers
High-grade cytology or high-grade histology
Multi-focal UTUC
Exception: Subjects with low-grade multi-focal tumours will be eligible if any ureteral tumours can be ablated before enrolment and if the total diameter of the multifocal tumours above the ureteropelvic junction is not exceeding 15 mm in diameter.
Bilateral disease
Trial design
Treatments tested in this trial
- Nadofaragene Firadenovec
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov