Safety of GX-188E DNA Therapeutic Vaccine Administered by Electroporation to Cervical Intraepithelial Neoplasia Grade 3

NCT01634503 | Completed Phase 1

• 1 other identifier: GX-188E-SN
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Intraepithelial Neoplasia 3

Keywords

3+3 design; Phase 1; Cervical Intraepithelial Neoplasia; Adult; Safety; Dose Finding

Outcome Measures

Primary Outcomes (1)

• Determination of maximum MTD by defining the safety profile of GX-188E

  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.

  From baseline to end of study

Secondary Outcomes (3)

• The expression levels of GX-188E in blood

  At week -2, week 2, week 12 ,week 20 and week 36

• Immunologic reactogenicity by measuring HPV E6 and E7 specific T cell response (IFN-γ ELISPOT)

  At week -2, week 2, week 12 ,week 20 and week 36

• The changes of the involved lesions and HPV infection status

  Baseline, week 12 ,week 20 and week 36

Study Arms (3)

1mg of GX-188E by electroporation

EXPERIMENTAL

Genetic: GX-188E administered by electroporation

2mg of GX-188E by electroporation

EXPERIMENTAL

Genetic: GX-188E administered by electroporation

4mg of GX-188E by electroporation

EXPERIMENTAL

Genetic: GX-188E administered by electroporation

Interventions

GX-188E administered by electroporation GENETIC

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.

Also known as: Trigrid™ Delivery System

1mg of GX-188E by electroporation; 2mg of GX-188E by electroporation; 4mg of GX-188E by electroporation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

Cheil General Hospital & Women's Healthcare Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Tae Jin Kim

  Cheil General Hospital & Women's Healthcare Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 17, 2014

Record last verified: 2014-02

Locations

KR (1)