This open-label study evaluates safety, vector shedding, and retreatment efficacy of Zopapogene imadenovec (Zopa) in adults with recurrent respiratory papillomatosis (RRP). Two cohorts will be enrolled (n=30): Cohort 1 to assess the magnitude and duration of adenoviral vector shedding in urine, feces, skin, and nasal tissue; Cohort 2 to assess the complete response rate following retreatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
RECRUITINGNational Institute of Health
Bethesda, Maryland, United States
RECRUITINGUniversity of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGCohort 1 Vector shedding
Magnitude and duration of Zopa vector shedding measured in urine, fecal, skin, and nasal tissue
Time frame: Up to 6 weeks following last administration, with additional collections if needed until two consecutive measurements at or below limit of detection
Cohort 2 Complete Response Rate
Percentage of subjects achieving a complete response defined as no clinically indicated debulking procedures during the 12 months following completion of Zopa retreatment.
Time frame: 12 months following last administration
Interval to First Debulking Procedure (Cohort 2)
Determine the interval to the first debulking procedure following retreatment with Zopapogene imadenovec (Zopa).
Time frame: 3 years following last administration
Safety and Tolerability of Zopa (Cohort 1 and Cohort 2)
Assess the safety and tolerability of Zopa in adult subjects with recurrent respiratory papillomatosis (RRP), including incidence and severity of adverse events graded per CTCAE v5.0.
Time frame: Up to 28 days after last administration, with extended monitoring during follow-up.
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