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 malignancies.
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 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.
- Signed and dated written Ethics Committee approved informed consent
- Age 18 years
- Histologically documented HPV 6 positive aerodigestive malignancy (mucosal squamous
cell head and neck cancer or lung cancer).
- 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
- 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
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Adverse events measured and graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
Injection site reactions including skin erythema, induration pain and tenderness at administration site