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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Nadofaragene Firadenovec
DrugRepeat dose trial to investigate the safety and efficacy of nadofaragene firadenovec instilled into the renal pelvis
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of treatment-emergent adverse events reported by each subject during the trial.
Time frame
Up to 30 months2
Complete response
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).
Time frame
Up to 6 monthsSecondary outcomes
1
Occurrence of anti-adenoviral antibodies.
Time frame
Up to 30 months2
Occurrence of anti-interferon-α2b (IFN-α2b) antibodies.
Time frame
Up to 30 months3
Shedding of adenoviral vector with IFN-α2b.
Time frame
Before dose and up to 15 days after dose4
Systemic exposures to IFN-α2b protein.
Time frame
Before dose and up to 15 days after doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov