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

Primary Purpose

Cervical Intraepithelial Neoplasia 3

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GX-188E, GX-I7

GX-188E, Imiquimod

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia 3 focused on measuring Investigator trial, Cervical Intraepithelial Neoplasia

Eligibility Criteria

19 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Seoul St. Mary's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GX-188E, GX-I7

GX-188E, Imiquimod

Arm Description

GX-188E + GX-I7

GX-188E + Imiquimod

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.

The change of cytology of uterine cervix compared to baseline.

Flt-3L concentrations in blood samples.

Full Information

NCT ID

NCT03206138

First Posted

June 20, 2017

Last Updated

June 29, 2017

Sponsor

Seoul St. Mary's Hospital

Collaborators

Genexine, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03206138

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 30, 2017 (Actual)

Primary Completion Date

October 2018 (Anticipated)

Study Completion Date

October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul St. Mary's Hospital

Collaborators

Genexine, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Intraepithelial Neoplasia 3

Keywords

Investigator trial, Cervical Intraepithelial Neoplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GX-188E, GX-I7

Arm Type

Experimental

Arm Description

GX-188E + GX-I7

Arm Title

GX-188E, Imiquimod

Arm Type

Experimental

Arm Description

GX-188E + Imiquimod

Intervention Type

Biological

Intervention Name(s)

GX-188E, GX-I7

Intervention Description

Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times.

Intervention Type

Biological

Intervention Name(s)

GX-188E, Imiquimod

Intervention Description

1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times.

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

The change of cytology of uterine cervix compared to baseline.

Time Frame

at screening, week 12, week 20, and week 36

Title

Flt-3L concentrations in blood samples.

Time Frame

at week 14, week 20, and week 36.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jong-Sup Park

Phone

+82-2-2258-2724

jspark@catholic.ac.kr

Facility Information:

Facility Name

Seoul St. Mary's hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact: