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

NCT03206138 | Unknown DMC

• 1 other identifier: GX-188E_GX-I7_IMQ_CIN3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia 3

Keywords

Investigator trial; Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (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 Outcomes (3)

• 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.

Study Arms (2)

GX-188E, GX-I7

EXPERIMENTAL

GX-188E + GX-I7

Biological: GX-188E, GX-I7

GX-188E, Imiquimod

EXPERIMENTAL

GX-188E + Imiquimod

Biological: GX-188E, Imiquimod

Interventions

GX-188E, GX-I7 BIOLOGICAL

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

GX-188E, GX-I7

GX-188E, Imiquimod BIOLOGICAL

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

GX-188E, Imiquimod

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• Genexine, Inc.: collaborator

Study Sites (1)

Seoul St. Mary's hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

efineptakin alfa; Imiquimod

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jong-Sup Park

CONTACT

+82-2-2258-2724; jspark@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: July 2, 2017
• Study Start: May 30, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

KR (1)