Zopa Retreatment and Vector Shedding in Adults With RRP
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrecigen, Inc
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Zopapogene imadenovec (Zopa)
DrugZopa will be administered as 4 subcutaneous administrations over a 12-week interval.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Cohort 1 Vector SheddingExperimental treatment 1 intervention
Group B: Cohort 2 RetreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 detection2
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 administrationSecondary outcomes
1
Interval to First Debulking Procedure (Cohort 2)
Determine the interval to the first debulking procedure following retreatment with Zopapogene imadenovec (Zopa).
Time frame
3 years following last administration2
Safety and Tolerability of Zopa (Cohort 1 and Cohort 2)
Assess the safety and tolerability of Zopa in adult subjects with recurrent respiratory papillomatosis (RRP), including incidence and severity of adverse events graded per CTCAE v5.0.
Time frame
Up to 28 days after last administration, with extended monitoring during follow-up.Sponsors and contacts
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Source ClinicalTrials.gov