Philadelphia, Pennsylvania 19104


Purpose:

This is a Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3106 alone or in combination with INO-9012 DNA vaccines delivered by Electroporation to subjects with HPV6 associated aerodigestive precancerous lesions and malignancies.


Study summary:

This is a Phase I, open-label, study to evaluate the safety, tolerability, and immunogenicity of 3 mg or 6 mg INO-3106 alone or in combination with 1 mg of INO-9012 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in subjects with HPV6 associated aerodigestive precancerous lesions and malignancies. Subjects will be enrolled in 2 cohorts (3 subjects in each cohort): Cohort I: First 3 subjects will be enrolled sequentially and will receive INO-3106 alone or in combination with INO-9012. Cohort II: The next 3 subjects will be treated with 6 mg of INO-3106 and 1 mg of INO-9012, or at the MTD (Maximum Tolerated Dose) determined in Cohort I.


Criteria:

Inclusion Criteria: - Signed and dated written Ethics Committee approved informed consent - Age ≥18 years - Histologically documented HPV-6 positive aerodigestive invasive malignancy (mucosal squamous cell head and neck cancer or lung cancer) who have completed therapies such as radiation/chemoradiation/chemotherapy; or - Histologically documented HPV-6 positive papilloma or HPV-6 related premalignant lesion (i.e., carcinoma in situ) in aerodigestive or head and neck regions. - Prior to study entry, subjects will have exhausted all treatments that are/have been used in these indications which may include any combination of surgery, anti-viral therapy, chemotherapy and/or radiation therapy. - Core biopsy must be obtained prior to enrollment to confirm invasive cancer. Archival material is allowed. - Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥ 1.5x109 cell/ml, platelets ≥75,000 cells/mm3, hemoglobin ≥ 9.0 g/dL, concentrations of total serum bilirubin within 1.5 x upper limit of normal (ULN), AST, ALT within 2.5x ULN, CPK within 2.5 x ULN, serum creatinine ≤ 1.5x ULN - ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 Exclusion Criteria: - Participation in a clinical trial within 30 days before entry - Any cardiac pre-excitation syndromes, e.g. Wolff-Parkinson-White syndrome - Presence of metal implants within 5 cm of the planned site(s) of injection - Anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids) - Administration of any vaccine within 6 weeks of enrollment


NCT ID:

NCT02241369


Primary Contact:

Study Director
Mark Bagarazzi, MD
Inovio Pharmaceuticals

Drishty Mangrolia
Phone: 267-440-4223
Email: clinical.trials@inovio.com


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States

Alison Berry
Phone: 215-662-2847
Email: alison.berry@uphs.upenn.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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