At a glance
ClinicalIndex Comparison Record- ✓Histologically documented HPV-6 or HPV-11-positive respiratory papilloma, or low-risk HPV positivity confirmed by sponsor-approved HPV-6/11 type-specific assay
- ✓At least 2 RRP surgical interventions (including laser) in the 12 months prior to and including Day 0
- ✓Appropriate candidate for upcoming surgical intervention per investigator judgment and RRP Staging Assessment score
- ✓Adequate bone marrow, hepatic, and renal function
- ✕RRP-directed therapy other than surgery or ablation within 3 months prior to Day 0 (antivirals including cidofovir, radiation, chemotherapy, anti-angiogenic therapy, prophylactic HPV vaccination as therapeutic intervention, experimental agents)
- ✕Ongoing or recent (within 1 year) autoimmune disease requiring systemic immunosuppressive treatment, except vitiligo, resolved childhood asthma, type 1 diabetes, residual hypothyroidism on hormone replacement, or psoriasis not requiring systemic treatment
- ✕Immunodeficiency diagnosis or systemic immunosuppressive therapy (including systemic corticosteroids) within 28 days prior to first trial dose
- ✕High bleeding risk or requirement for anticoagulants for known bleeding diathesis management
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Multi-center Study of INO-3107 With Electroporation (EP) in Subjects With HPV-6- and/or HPV-11-associated Recurrent Respiratory Papillomatosis (RRP)
In Brief
A Phase 2 clinical trial evaluating INO-3107 and CELLECTRA® 2000 for Respiratory Papillomatosis. Completed, enrolled 32 participants across 11 sites.
Detailed 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.
Study Details
Timeline
Interventions
INO-3107 administered by IM injection.
CELLECTRA® 2000 device used for EP following IM delivery of INO-3107.