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

Sponsor
Seoul St. Mary's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03206138
Collaborator
Genexine, Inc. (Industry)
50
Enrollment
1
Location
2
Arms
16.1
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: GX-188E, GX-I7
  • Biological: GX-188E, Imiquimod
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
May 30, 2017
Anticipated Primary Completion Date :
Oct 1, 2018
Anticipated Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: GX-188E, GX-I7

GX-188E + GX-I7

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.
Experimental: GX-188E, Imiquimod

GX-188E + Imiquimod

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less. [at week 20, and week 36]

  2. The change of cytology of uterine cervix compared to baseline. [at screening, week 12, week 20, and week 36]

  3. Flt-3L concentrations in blood samples. [at week 14, week 20, and week 36.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul St. Mary's hospital Seoul Korea, Republic of 06591

Sponsors and Collaborators

  • Seoul St. Mary's Hospital
  • Genexine, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jongsup Park, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT03206138
Other Study ID Numbers:
  • GX-188E_GX-I7_IMQ_CIN3
First Posted:
Jul 2, 2017
Last Update Posted:
Jul 2, 2017
Last Verified:
Jun 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jongsup Park, Professor, Seoul St. Mary's Hospital
Investigator trial
Cervical Intraepithelial Neoplasia
Additional relevant MeSH terms:
Neoplasms
Cervical Intraepithelial Neoplasia
Imiquimod

Study Results

No Results Posted as of Jul 2, 2017