INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)
NCT04398433 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-04-14
Summary
This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in participants with human papilloma virus type 6 (HPV-6) and/or type 11 (HPV-11)-associated recurrent respiratory papillomatosis (RRP). The trial population will include participants who have been diagnosed with either Juvenile-Onset RRP (J-O RRP) as defined by age at first diagnosis \<12 years or with Adult- Onset RRP (A-O RRP) as defined by age at first diagnosis ≥12 years. A safety run-in will be performed with up to six participants with a one week waiting period between each enrolled participant.
Conditions
- Respiratory Papillomatosis
Interventions
- DRUG
-
INO-3107 administered by IM injection.
- DEVICE
-
CELLECTRA® 2000
CELLECTRA® 2000 device used for EP following IM delivery of INO-3107.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Jeffrey Skolnik, MD · Inovio Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-07
- Primary Completion
- 2022-12-15
- Completion
- 2022-12-15
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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