Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.

Overview

This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.

Full Title of Study: “A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2018

Interventions

  • Biological: GX-188E, GX-I7
    • Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times.
  • Biological: GX-188E, Imiquimod
    • 1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times.

Arms, Groups and Cohorts

  • Experimental: GX-188E, GX-I7
    • GX-188E + GX-I7
  • Experimental: GX-188E, Imiquimod
    • GX-188E + Imiquimod

Clinical Trial Outcome Measures

Primary Measures

  • Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
    • Time Frame: at week 20

Secondary Measures

  • Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.
    • Time Frame: at week 20, and week 36
  • The change of cytology of uterine cervix compared to baseline.
    • Time Frame: at screening, week 12, week 20, and week 36
  • Flt-3L concentrations in blood samples.
    • Time Frame: at week 14, week 20, and week 36.

Participating in This Clinical Trial

Inclusion Criteria

  • Able and willing to comply with all study procedures and voluntarily signs informed consent form. – Female subjects age 19-50 years. – HPV 16 and/or 18 positive. – Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area – Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3. Exclusion Criteria:
  • Pregnancy or breastfeeding – History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded). – Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV). – Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.
  • Gender Eligibility: Female

    Minimum Age: 19 Years

    Maximum Age: 50 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Seoul St. Mary’s Hospital
    • Collaborator
      • Genexine, Inc.
    • Provider of Information About this Clinical Study
      • Principal Investigator: Jongsup Park, Professor – Seoul St. Mary’s Hospital
    • Overall Contact(s)
      • Jong-Sup Park, +82-2-2258-2724, jspark@catholic.ac.kr

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