Clinical trial · Interventional
Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.
A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.
NCT03206138CI-TRIAL-00028365unknownN/AClinicalTrials.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 is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GX-188E, GX-I7 | Biological | — | UNRESOLVED |
| GX-188E, Imiquimod | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GX-188E, GX-I7
- description
- GX-188E + GX-I7
- interventionNames
- Biological: GX-188E, GX-I7
- type
- EXPERIMENTAL
- label
- GX-188E, Imiquimod
- description
- GX-188E + Imiquimod
- interventionNames
- Biological: GX-188E, Imiquimod
Primary outcomes (1)
- measure
- Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
- timeFrame
- at week 20
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Able and willing to comply with all study procedures and voluntarily signs informed consent form. * Female subjects age 19-50 years. * HPV 16 and/or 18 positive. * Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area * Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3. Exclusion Criteria: * Pregnancy or breastfeeding * History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded). * Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV). * 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.