Clinical Trial Details
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Phase IIIInterventional
Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis
Protocol: STUDY00008789NCT: NCT06538480
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.
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
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.
