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The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 3 (CIN3).
Subjects who are eligible for this study are allocated to one of the two treatment groups of GX-188E. All Subject received GX-188E intramuscularly using the electroporator(EP) on alternating deltoid muscles which will be performed totally three times during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1mg of GX-188E per dose | Experimental | 1mg of GX-188E per dose will be administered on 1mg group participants through intramuscular route using EP device. The injection points are at 0 week, 4 week and 12 week. |
|
| 4mg of GX-188E per dose | Experimental | 4mg of GX-188E per dose will be administered on 4mg group participants through intramuscular route using EP device. The injection points are at 0 week, 4 week and 12week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-188E | Biological | DNA vaccine administered via IM route using TDS-IM electroporation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Participants Whose Result Inverted Negative in HPV DNA test | 20 weeks | |
| The rate of HPV E6, E7-specific ELISPOT responder defined in the protocol | 20 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Park Jong-Sup, M.D. | The Catholic University of Korea | Principal Investigator |
| Kim Tae-Jin, M.D. | Cheil General Hospital & Women's Healthcare Center | Principal Investigator |
| Lee Jae-kwan, M.D. | Korea University Guro Hospital | Principal Investigator |
| Cho Chi-heum, M.D. | Keimyung University Dongsan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Daegu | 700-712 | South Korea | |||
| Cheil General Hospital & Women's Healthcare Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38330377 | Derived | Cho HW, Jeong S, Song SH, Kim YT, Kim JW, Cho CH, Hur SY, Chang SJ, Kim YM, Lee JK. A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2. J Gynecol Oncol. 2024 Jul;35(4):e52. doi: 10.3802/jgo.2024.35.e52. Epub 2024 Jan 24. |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D030361 | Papillomavirus Infections |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D002577 | Uterine Cervical Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000604106 | GX-188 vaccine |
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| Cytological Changes of the Cervical Lesions |
| 20 weeks |
| The Rate of Adverse Events and the Related Features after Administration of Investigational Product | 20 weeks |
| The Rate of Solicited Adverse Events and the Related Features | 20 weeks |
| Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product | 20 weeks |
| Mean Value of Visual Analogue Scale on Pain Intensity | 20 weeks |
| Flt-3L Serum Concentration | 20 weeks |
| Seoul |
| 100-380 |
| South Korea |
| The Catholic University of Korea Seoul St.Mary's Hospital | Seoul | 137-701 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |