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RecruitingInterventionalPhase 4

Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis

NCT ID: NCT06538480Sponsor: Precigen, IncLast updated: 2025-12-15

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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Key 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. Key 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.

Study locations (3)

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322

Recruiting
Mosope Oyewole, CRC · Contact
Nabil Saba, MD · Principal Investigator

National Institute of Health

Bethesda, Maryland, 20892

Recruiting
Shannon Householder, RN · Contact
Scott Norberg, DO · Contact

University of Cincinnati

Cincinnati, Ohio, 45267

Recruiting
Rebecca Reinert · Contact
Aaron Friedman, MD · Principal Investigator
Zopa Retreatment and Vector Shedding in Adults With RRP | Cancerify