Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis
Summary
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.
Arms & interventions
- DrugZopapogene imadenovec (Zopa)
Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.
Outcome measures
Primary
Cohort 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
Secondary
Interval to First Debulking Procedure (Cohort 2)
Time frame: 3 years following last administration
Safety and Tolerability of Zopa (Cohort 1 and Cohort 2)
Time frame: Up to 28 days after last administration, with extended monitoring during follow-up.
Eligibility criteria
Study locations (3)
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
National Institute of Health
Bethesda, Maryland, 20892
University of Cincinnati
Cincinnati, Ohio, 45267