Cervical Intraepithelial Neoplasia 3 Clinical Trial
Official title:
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 to determine maximum tolerable dose (MTD) of GX 188E by defining the safety profile the safety and maximum tolerated dose of GX-188E administered by electroporation in Cervical Intraepithelial Neoplasia grade 3 (CIN 3) patients.
This study is an open-label, dose-escalation, single-center, phase I study to evaluate the
safety of GX-188E, a DNA-based therapeutic vaccine, administered by electroporation (EP) in
patients with HPV-16 or HPV-18 associated cervical intraepithelial neoplasia grade 3 (CIN
3).
Each subject eligible to participate in the trial is given a subject number, which is
assigned sequentially in ascending order, then allocated to only a single dose level of the
drug. Three subjects are allocated at each dose level starting with 1mg whereby the dose is
escalated in sequential subjects in ascending numerical order of subject ID.
Each subject visit the site three times for administration during the study and is given an
intramuscular injection of GX-188E at a dose of 1mg, 2mg or 4mg by electroporation at each
visit
The subjects conduct the follow-up visits twice, which are 8 weeks and 24 weeks after the
third injection of GX-188E respectively.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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