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

Seoul St. Mary's Hospital

Status: Unknown

Conditions: Cervical Intraepithelial Neoplasia 3

Treatments: Biological: GX-188E, GX-I7; Biological: GX-188E, Imiquimod

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03206138

GX-188E_GX-I7_IMQ_CIN3

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

GX-188E, GX-I7

Experimental group

Description:

GX-188E + GX-I7

Treatment:

Biological: GX-188E, GX-I7

GX-188E, Imiquimod

Experimental group

Description:

GX-188E + Imiquimod

Treatment:

Biological: GX-188E, Imiquimod