Clinical trial · Interventional
Safety of GX-188E DNA Therapeutic Vaccine Administered by Electroporation to Cervical Intraepithelial Neoplasia Grade 3
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)
NCT01634503CI-TRIAL-00013783CIN3completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia 3 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GX-188E administered by electroporation | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1mg of GX-188E by electroporation
- interventionNames
- Genetic: GX-188E administered by electroporation
- type
- EXPERIMENTAL
- label
- 2mg of GX-188E by electroporation
- interventionNames
- Genetic: GX-188E administered by electroporation
- type
- EXPERIMENTAL
- label
- 4mg of GX-188E by electroporation
- interventionNames
- Genetic: GX-188E administered by electroporation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.