A Single Center, Open-label, Dose-escalating, Phase Ι Study to Evaluate the Safety of GX-188E Administered by Electroporation (EP) in DNA-based Therapeutic Vaccine for Patients With Cervical Intraepithelial Neoplasia Grade 3 (CIN 3)
This study is an open-label, dose-escalating phase 1 trial based on the classical 3+3 study
design. The patients enrolled in the trial will be successively allocated into three cohorts
for GX-188E(1mg, 2mg, 4mg) according to the classical 3+3 protocol design.
The scheduled assessments and visits will be carried out over three periods; run-in period,
treatment period, and follow-up period.
The run-in period includes the screening visit where a written informed consent is obtained
and the screening period where patients are assessed for eligibility. It will be completed
within 14 days prior to Visit 1. The patients meeting the inclusion criteria will start the
During the treatment period, subjects will be administered GX-188E by electroporation based
on the protocol.
The Follow-up period starts at the completion of the treatment period and patients will be
followed up for safety at 6 months and 9 months since the last administration of GX-188E.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety profile of GX-188E administered by Electroporation
This will be determined by the 3+3 design.
Tae Jin Kim
Cheil General Hospital & Women's Healthcare Center
Korea: Food and Drug Administration