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

Not Applicable

• Conditions: Cervical Intraepithelial Neoplasia 3
• Interventions: Biological: GX-188E, GX-I7; Biological: GX-188E, Imiquimod

• Registration Number: NCT03206138
• Lead Sponsor: Seoul St. Mary's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-30
• Status Verified: 2017-06
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GX-188E, GX-I7	GX-188E, GX-I7	GX-188E + GX-I7
GX-188E, Imiquimod	GX-188E, Imiquimod	GX-188E + Imiquimod

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
The change of cytology of uterine cervix compared to baseline.	at screening, week 12, week 20, and week 36
Flt-3L concentrations in blood samples.	at week 14, week 20, and week 36.

Trial Locations

Locations (1)

Seoul St. Mary's hospital; 🇰🇷 Seoul, Korea, Republic of