Clinical trial · Interventional
Zopa Retreatment and Vector Shedding in Adults With RRP
Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillomaviridae | — | UNRESOLVED | — |
| Papillomavirus Infection | — | UNRESOLVED | — |
| Recurrent Respiratory Papillomatosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zopapogene imadenovec (Zopa) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1 Vector Shedding
- description
- Zopa administered subcutaneously at 5 × 10\^11 particle units on Day 1, Week 2, Week 6, and Week 12. Samples for vector shedding to be collected from urine, feces, skin, and nasal tissue.
- interventionNames
- Drug: Zopapogene imadenovec (Zopa)
- type
- EXPERIMENTAL
- label
- Cohort 2 Retreatment
- description
- Patients with prior treatment with Zopa (5 × 10\^11 PU per injection) and require clinically indicated debulking procedure
- interventionNames
- Drug: Zopapogene imadenovec (Zopa)
Primary outcomes (2)
- measure
- Cohort 1 Vector shedding
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available