Zopa Retreatment and Vector Shedding in Adults With RRP

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Precigen, Inc
Study ID
NCT06538480
Phase
PHASE4
Status
Recruiting
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Conditions

  • Papillomaviridae
  • Papillomavirus Infection
  • Recurrent Respiratory Papillomatosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zopapogene imadenovec (Zopa) — DRUG
    Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.

Study Details

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.

Key Dates

Start date
Jul 11, 2024
Status verified
Dec 2025
Primary completion
Dec 2, 2027
Completion
Dec 2, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 Vector Shedding
    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.
  • Experimental: Cohort 2 Retreatment
    Patients with prior treatment with Zopa (5 × 10\^11 PU per injection) and require clinically indicated debulking procedure

Primary Outcome Measure

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322
Mosope Oyewole, CRC
[email protected]
404-778-5351
Nabil Saba, MD (PRINCIPAL_INVESTIGATOR)
National Institute of HealthBethesdaMaryland20892
Shannon Householder, RN
[email protected]
240-656-8771
Scott Norberg, DO
University of CincinnatiCincinnatiOhio45267
Rebecca Reinert
[email protected]
513-558-1719
Aaron Friedman, MD (PRINCIPAL_INVESTIGATOR)

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Winship Cancer Institute, Emory University· Atlanta, GANational Institute of Health· Bethesda, MDUniversity of Cincinnati· Cincinnati, OH

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