Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Carcinoma

Carcinoma in Situ

Uterine Cervical Dysplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Vaccines

Subjects in the period less than 24 weeks after the final administration of GX-188E

In phase II study, 72 patients were assigned to two dose groups (1mg and 4mg) and were administered three times with GX-188E by electroporation during an entire period of study. After the final administration, the follow-up will be conducted to investigate safety and efficacy aspects.

GX-188E

Jong-Sup Park, M.D.

Tae-Jin Kim, M.D.

Jae-Kwan Lee, M.D.

Chi-Heum Cho, M.D.

This study is to follow up on the change of immune response by measuring HPV type 16/18 E6 and E7 specific T cell response and lesion condition in subjects who have administered in DNA-based therapeutic vaccine.

This is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (CIN) 3 who have enrolled and participated GX-188E phase II trial(GX-188E_CIN3_P2).

Subjects will make visits 7 times for about three years from the last visit of GX-188E phase 2 trial (GX-188E_CIN3_P2).

The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase 2 trial (GX-188E_CIN3_P2).

plasma and PBMC (peripheral blood mononeuclear cell)

Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation

A Prospective, Observational, Open-label, Multi-center, Follow-up Clinical Study to Determine Recurrence of Cervical Intraepithelial Neoplasia and Evaluate the Long-term Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in Subjects Who Were Diagnosed With HPV(Human Papillomavirus) 16 or 18 Positive Cervical Intraepithelial Neoplasia 3 (CIN 3) and Participated in Phase 2 Trial (GX-188E_CIN3_P2)

long term safety assessment of GX-188E DNA vaccine of subjects participated in GX-188E_ CIN3_P2 clinical trial

- Safety profile would be examined by physical examination, vital signs, ECG, clinical laboratory test etc

The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study

The change of HPV infection status would be compared to that of the last visit in phase II study.

The change of cytology status would be compared to that of the last visit in phase II study.

It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-γ ELISPOT: enzyme-linked immunospot assay) using PBMC(peripheral blood monocyte).

The matters relevant to the subject of pregnancy and delivery would be collected by survey to identify occurence, frequency and characteristic.

Genexine, Inc.

Antineoplastic Agents

Anti-Infective Agents

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times.

GX-188E, GX-I7

1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times.

GX-188E, Imiquimod

Jong-Sup Park

Genexine

Jong-Sup Park, M.D

Tae-Jin Kim, M.D

Jae-Kwan Lee, M.D

Young Tae Kim, M.D

Chi-Heum Cho, M.D

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.

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.

Seoul St. Mary's Hospital

Professor

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.

GX-188E administered by electroporation

Tae Jin Kim

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.

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.

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)

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.

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Glioblastoma

Head and Neck Neoplasms

Anus Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Uterine Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Anal Cancer

Neuroepithelioma

Patient receiving an anticancer treatment in the context of their standard care.

Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice):

* at Baseline.
* at every surgical procedure or tumor biopsy.
* every 6 months (± 2 months) (only blood sample).
* at the time of the progression or recurrence, if applicable.

For patients undergoing a RT treatment, blood samples will be collected before the RT (i.e. at the time of planning CT-scan), at the last session of RT (± 2 days) and 3 months after the end of the RT (± 2 weeks).

Blood samples, tumor biopsy specimens and ascites samples will be collected.

Alejandra MARTINEZ

Julien MAZIERES

Rosine GUIMBAUD

This trial is a translational, open-label, multicentric, prospective cohort study of 900 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors.

The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial.

Patients with any of the following tumor types may be enrolled in the trial:

* Head and neck cancer,
* Ovarian cancer,
* Cervical cancer,
* Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer),
* Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer)

Each tumor type will be considered as an independent cohort.

For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected.

Study participation of each patient will be 5 years.

Deciphering Mechanisms Underlying Cancer Immunogenicity

Institut Claudius Regaud

Subjects in the period less than 48 weeks after the final administration of GX-188E

In phase I study, 9 patients were assigned to three dose groups (1mg, 2mg and 4mg) and were administered three times with GX-188E by electroporation during an entire period of study. After the final administration, the follow-up will be conducted to investigate safety and efficacy aspects.

Tae Jin Kim, M.D.

This is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (CIN) 3 who have enrolled and completed GX-188E phase I study.

Subjects will make visits at week 48 (V1) to week 228 (V8) every 6 months after the final administration of GX-188E.

The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase I study.

plasma and PBMC (peripheral blood mononeuclear cells)

A Single Center, Phase I Study to Follow-up on the Change of Immunogenicity and Lesion Condition in Subjects Who Have Completed the Phase I GX-188E Trial (Protocol no. GX-188E-SN)

It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-γ ELISPOT assay) using PBMC obtained at week 0 to 180 visit every 6 months.

The changes of histological test, cytological test and HPV infection status would be compared to that of the last visit in phase I study

Safety profile would be examined by vital signs, physical examination, clinical laboratory tests etc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation	NCT02411019	Cervical Intrae...	GX-188E	19 Years - 50 Years	Genexine, Inc.
Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation	NCT02411019	Cervical Intrae...	GX-188E	19 Years - 50 Years	Genexine, Inc.
Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.	NCT03206138	Cervical Intrae...	GX-188E, GX-I7 GX-188E, Imiqui...	19 Years - 50 Years	Seoul St. Mary's Hospital
Safety of GX-188E DNA Therapeutic Vaccine Administered by Electroporation to Cervical Intraepithelial Neoplasia Grade 3	NCT01634503	Cervical Intrae...	GX-188E adminis...	20 Years - 50 Years	Genexine, Inc.
Deciphering Mechanisms Underlying Cancer Immunogenicity	NCT03958240	Head and Neck C... Ovarian Cancer Cervical Cancer Cervical Intrae... Glioblastoma Mu... Non Small Cell ... Anal Cancer	Blood samples, ...	18 Years -	Institut Claudius Regaud
Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation	NCT02100085	Cervical Intrae...	GX-188E	20 Years - 50 Years	Genexine, Inc.
Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.	NCT03206138	Cervical Intrae...	GX-188E, GX-I7 GX-188E, Imiqui...	19 Years - 50 Years	Seoul St. Mary's Hospital
Safety of GX-188E DNA Therapeutic Vaccine Administered by Electroporation to Cervical Intraepithelial Neoplasia Grade 3	NCT01634503	Cervical Intrae...	GX-188E adminis...	20 Years - 50 Years	Genexine, Inc.
Deciphering Mechanisms Underlying Cancer Immunogenicity	NCT03958240	Head and Neck C... Ovarian Cancer Cervical Cancer Cervical Intrae... Glioblastoma Mu... Non Small Cell ... Anal Cancer	Blood samples, ...	18 Years -	Institut Claudius Regaud
Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.	NCT03206138	Cervical Intrae...	GX-188E, GX-I7 GX-188E, Imiqui...	19 Years - 50 Years	Seoul St. Mary's Hospital

Spots Global Cancer Trial Database for cervical intraepithelial neoplasia 3