Zopa Retreatment and Vector Shedding in Adults With RRP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zopapogene imadenovec (Zopa).
- Who it may be relevant to
- Registry conditions: Recurrent Respiratory Papillomatosis, Papillomavirus Infection, Papillomaviridae. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis
Overview
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.
Interventions
- Drug Zopapogene imadenovec (Zopa)
Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.
Primary outcome measures
- Cohort 1 Vector shedding [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 [Time frame: 12 months following last administration]
Secondary outcome measures (2)
- 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
Inclusion criteria
- Age 18 years and older.
- Clinical diagnosis of recurrent respiratory papillomatosis with histological confirmation of papilloma.
- Cohort 1: Treatment-naïve with respect to Zopa.
- Cohort 2: Received a minimum of four administrations of Zopa at 5 × 10\^11 PU per injection and require clinically indicated debulking procedures.
- Presence of laryngotracheal papillomas accessible for endoscopic cleanout.
- ECOG performance status 0 or 1.
- Sexually active participants of reproductive potential must agree to use contraception during treatment and for 120 days for males and 6 months for females after last dose.
- Ability to understand and sign informed consent.
Exclusion criteria
- Conditions or therapies that increase risk or interfere with participation per investigator judgment.
- Systemic corticosteroids >10 mg prednisone equivalent or other immunosuppressive medications within 14 days prior to dosing.
- Other systemic RRP treatments or investigational agents within 30 days.
- History of heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia.
- Active uncontrolled HIV, hepatitis B, or hepatitis C infection.
- Pregnant or nursing women.
- Known allergy to any study drug component.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Winship Cancer Institute, Emory University — Atlanta
- National Institute of Health — Bethesda
- University of Cincinnati — Cincinnati
Identifiers
NCT: NCT06538480 · PRGN-2012-301