- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01634503
Safety of GX-188E DNA Therapeutic Vaccine Administered by Electroporation to Cervical Intraepithelial Neoplasia Grade 3 (CIN3)
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of
- Cheil General Hospital & Women's Healthcare Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female aged between 20 and 50(inclusive).
- Those who promised not to get pregnant from initiation to the first follow-up visit
- Who has diagnosed with Cervical Intraepithelial Neoplasia 3 by histopathologic examination and HPV type 16 or 18 detected
- Those who signed a voluntary written informed consent form for study participation.
Exclusion Criteria:
- Pregnant or lactating women.
- Administration of immunosuppressant or immunomodulator within 6 months prior to the enrollment
- Concomitant medication of any corticosteroid agents within 4 weeks prior to vaccination with the test drug
- Prior immunotherapy against HPV
- Administration of any blood products within 3 months prior to the screening visit
- Administration of any vaccine within 4 weeks prior to the screening visit (ex. Hepatitis A vaccine, Hepatitis B vaccine, Influenza vaccine, Td etc.)
- Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg), or HIV
- Prior participation in any clinical trial within 30 days prior to the screening visit
- Patients predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
- Past history of epilepsy or convulsion within 2 years prior to the screening visit
- At the discretion of the investigator, the skin condition covering deltoid muscles, within 2cm of the intended sites of injection, is not suitable for injection due to infection, ulcer, edema, tattoo, scar, injury etc.
- The thickness of skin fold covering deltoid muscles, intended injection sites, >40mm
- Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles)
- Any history of severe adverse drug events or severe allergic diseases
- Sinus bradycardia whose resting heart rate < 50beats/min.
- Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
- Artificial implants or metallic implants
- Abnormal electrocardiography (ECG) including arrhythmia
- Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1mg of GX-188E by electroporation
|
Patients will be assigned to three dose groups:1mg, 2mg, and 4mg.
Each patient will be administered GX-188E by electroporation in entire study period.
The Maximum Tolerated Dose of GX-188E will be determined by the classical 3+3 dose escalation schedule.
The number of patients will be ranged from 9 to 18.
Other Names:
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Experimental: 2mg of GX-188E by electroporation
|
Patients will be assigned to three dose groups:1mg, 2mg, and 4mg.
Each patient will be administered GX-188E by electroporation in entire study period.
The Maximum Tolerated Dose of GX-188E will be determined by the classical 3+3 dose escalation schedule.
The number of patients will be ranged from 9 to 18.
Other Names:
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Experimental: 4mg of GX-188E by electroporation
|
Patients will be assigned to three dose groups:1mg, 2mg, and 4mg.
Each patient will be administered GX-188E by electroporation in entire study period.
The Maximum Tolerated Dose of GX-188E will be determined by the classical 3+3 dose escalation schedule.
The number of patients will be ranged from 9 to 18.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of maximum MTD by defining the safety profile of GX-188E
Time Frame: From baseline to end of study
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It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs and so on.
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From baseline to end of study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The expression levels of GX-188E in blood
Time Frame: At week -2, week 2, week 12 ,week 20 and week 36
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At week -2, week 2, week 12 ,week 20 and week 36
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Immunologic reactogenicity by measuring HPV E6 and E7 specific T cell response (IFN-γ ELISPOT)
Time Frame: At week -2, week 2, week 12 ,week 20 and week 36
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At week -2, week 2, week 12 ,week 20 and week 36
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The changes of the involved lesions and HPV infection status
Time Frame: Baseline, week 12 ,week 20 and week 36
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Baseline, week 12 ,week 20 and week 36
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tae Jin Kim, Cheil General Hospital & Women's Healthcare Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GX-188E-SN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Intraepithelial Neoplasia 3
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BioLeaders CorporationUnknownCervical Intraepithelial Neoplasia Grade 2/3Korea, Republic of
-
National Cancer Institute (NCI)TerminatedCervical Cancer | Cervical Intraepithelial Neoplasia Grade 2 | Cervical Intraepithelial Neoplasia Grade 3United States
-
Genexine, Inc.UnknownCervical Intraepithelial Neoplasia 3Korea, Republic of
-
Genexine, Inc.UnknownCervical Intraepithelial Neoplasia 3Korea, Republic of
-
Seoul St. Mary's HospitalGenexine, Inc.UnknownCervical Intraepithelial Neoplasia 3Korea, Republic of
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Carcinoma | Cervical Intraepithelial Neoplasia Grade 2/3 | Stage 0 Cervical CancerUnited States
-
Tampere UniversityEuropean Union; Academy of Finland; Cancer Society of FinlandActive, not recruitingCervical Intraepithelial Neoplasia Grade 2/3Finland
-
GY Highland Biotech LLCUnknownCervical Intraepithelial Neoplasia Grade 2/3United States
-
Asieris MediTech (Hong Kong) Co., Ltd.Active, not recruitingCervical Intraepithelial Neoplasia Grade 2/3China
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI); National Institutes of Health (NIH)CompletedHPV16 Positive | Cervical Intraepithelial Neoplasia (CIN 2/3)United States
Clinical Trials on GX-188E administered by electroporation
-
Genexine, Inc.UnknownCervical Intraepithelial Neoplasia 3Korea, Republic of
-
Genexine, Inc.UnknownCervical Intraepithelial Neoplasia 3Korea, Republic of
-
Newish Technology (Beijing) Co., Ltd.Recruiting
-
Yonsei UniversityRecruitingHead and Neck Squamous Cell CarcinomaKorea, Republic of
-
Yonsei UniversityWithdrawnPulmonary Tuberculoses | Treatment Failure | High Risk Factors for Relapse
-
Newish Technology (Beijing) Co., Ltd.RecruitingHigh-grade Squamous Intraepithelial Lesion (HSIL)China
-
Seoul St. Mary's HospitalGenexine, Inc.UnknownCervical Intraepithelial Neoplasia 3Korea, Republic of
-
Quantum Genomics SACompletedHypertensionUnited States, Czechia, France, Germany, Poland, Spain
-
Yonsei UniversityRecruitingHead and Neck Squamous Cell CarcinomaKorea, Republic of
-
Genexine, Inc.CompletedCervical Intraepithelial NeoplasiaKorea, Republic of