Aerodigestive Precancerous Lesions and Malignancies Clinical Trial
Official title:
A Study of HPV Specific Immunotherapy in 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 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.
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