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

Cervical Intraepithelial Neoplasia 3 Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03206138
• Other study ID #: GX-188E_GX-I7_IMQ_CIN3
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2017
• Last updated: June 29, 2017
• Start date: May 30, 2017
• Est. completion date: October 2018

Study information

• Verified date: June 2017
• Source: Seoul St. Mary's Hospital
• Contact: Jong-Sup Park
• Phone: +82-2-2258-2724
• Email: jspark[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia 3
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The change of cytology of uterine cervix compared to baseline.		at screening, week 12, week 20, and week 36
Secondary	Flt-3L concentrations in blood samples.		at week 14, week 20, and week 36.