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)
20 Years
50 Years
Female
Cervical Intraepithelial Neoplasia Grade 3
Trial Information
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
treatment period.
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.
Inclusion Criteria:
- Female aged between 20 and 50(inclusive).
- Those who promised not to get pregnant during the study period.
- Those who signed a voluntary written informed consent form for study participation.
Exclusion Criteria:
- Pregnant or lactating women.
- Those who have taken corticosteroid as a concomitant medication within 4 weeks of
vaccination with the study drug.
- Those who have been treated with HPV immunotherapy.
- Those who were administered blood products within 3 months of screening
- Those who were vaccinated with HPV preventive vaccine.
- Those who tested positive for hepatitis C virus, hepatitis B virus surface
antigen(HBsAg), or HIV.
- Those who participated in other clinical trials within 30 days of screening visit.
- Patients who are likely to have inflammation due to use of medical devices such as
electroporation within 30 days of screening visit.
- Patients who had a history of epilepsy or convulsion within 2 years of screening.
- Patients who are determined by the principal investigator to have deltoid muscles not
suitable for this study due to infection, ulcer, edema, tattoo, scar, injury or etc.
- Those who were injected with manmade materials as a result of orthopedic surgery on
the site of electroporation
- Those who have shown serious adverse or allergic reactions to drugs
- Those with pre-excitation syndromes such as Wolff-Parkinson-White syndrome.
- Patients with were implanted with metals or other manmade materials.
- Other cases unsuitable to participate in this study as determined by the Principal
Investigator.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety profile of GX-188E administered by Electroporation
Outcome Description:
This will be determined by the 3+3 design.
Outcome Time Frame:
One year
Safety Issue:
Yes
Principal Investigator
Tae Jin Kim
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cheil General Hospital & Women's Healthcare Center
Authority:
Korea: Food and Drug Administration
Study ID:
GX-188E-SN
NCT ID:
NCT01634503
Start Date:
November 2012
Completion Date:
August 2013
Related Keywords:
- Cervical Intraepithelial Neoplasia Grade 3
- 3+3 design
- Phase 1
- Cervical Intraepithelial Neoplasia
- Adult
- Safety
- Dose Finding
- Neoplasms
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
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