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.
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.
- 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
- 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