Head and Neck Cancer
Conditions
Keywords
head and neck cancer, gene therapy, stem cell therapy, immunotherappy
Brief summary
The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after intratumoral injection in head and neck cancer patience.
Detailed description
The primary purpose of the study is to determine MTD(Maximum Tolerable Dose) of GX-051 administered in tumor. The second purpose is to evaluate safety and efficacy of GX-051.
Interventions
BIOLOGICALGX-051
intratumoral injection
Sponsors
Genexine, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are capable of understanding and complying with the requirements of the study and have signed the informed consent from (ICF). * Very advanced head and neck cancer aged more than 19. * Longest distance of the tumor is bigger than 1 cm and capable of Intratumoral injection. * Baseline ECOG Performance Status 0, 1 or 2. * Have a life expectancy more than 6 months.
Exclusion criteria
* Have no history of prior anticancer treatment. * Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.Subject who have participated in a clinical trial of an treatment vaccine or immunotherapy in an year. * Have a tumor which is near a main vessel that can be occured embolism after injection or which has hypervascularity. * Patients currently receiving anticancer immuno-therapies Patients who have received prior treatment with an stem cell therapy. * Have autoimmune disease (multiple sclerosis, systemic lupus erythromatosis, thyroiditis, psoriasis, inflammatory bowel diseases etc.). * Have Graft rejection reaction such as GVHD. * Have immunodeficiency disease. * Leukocytes\< 3.0 x109/L. * Absolute neutrophil count \< 1.5x109/L. * Platelet count \< 100 x 109/L. * Have known positive test for hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV). * Alanine Aminotransferase (ALT) \> 2.5xUNL. * Aspartate Aminotransferase (AST)\> 2.5xUNL. * Total Bilirubin\> UNL. * Have blood Creatinine\> UNL. * Known allergy to IL-12 or the excipient(s) of the study medication including fetal bovine serum. * Second primary cancer Metastatic brain tumor or meningioma. * Have a tumor near a main artery. * Uncontrolled hypertension. * Uncontrolled diabetes uncontrolled (arrhythmia). * Heart failure (more than NYHA Functional Class II); unstable coronary artery disease; myocardial infarction within 6 months. * Child-Pugh Class C hepatic impairment. * Severe renal impairment (creatinine clearance \< 30 ml/min) or on dialysis. * Have active infection or history of recurrent infection. * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. * Are considered ineligible by the investigator due to a mental disease or CNS disease. * Administration of any other tumor therapy, including chemotherapy and radiotherapy within 4 weeks(6 weeks in case of nitrosoureas and mytomycin C) before the beginning of study treatment. * Patients receiving chronic, systemic treatment with immunosuppressive agent(steroid) or immuno-modulator within 2 weeks prior to screening. * Have participated in another clinical trial within 30 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD after GX-051 intratumoral injection | 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of antibody generation against IL-12 which is active ingredient of GX-051 | 2 months | We will analyze anti-IL-12 antibody in blood by ELISA on the screening visit and the follw up visit. Result will report as existence or absence of the anti-body . |
| Adverse events after GX-051 intratumoral injection | 2 months | — |
| Changes of immune cell distribution in tumor tissue after GX-051 intratumoral injection | 2 months | We will analyze immune cells such as CD4+ T cell, CD8+ T cell, NK cell by FACS analysis on day 1(baseline), day 29(end of treatment) and day 57(follow up) |
| Changes of INF-γ and IL-12 levels in blood comparing to the baseline after GX-051 intratumoral injection | 2 months | unit: pg/ml |
| Evaluation of long term safety examined by vital sign, physical examination, clinical laboratory tests, CT etc | 17 monthes | Safety profile would be examined by vital sign, physical examination, clinical laboratory tests, CT etc |
| Anti-tumor response by RECIST 1.1 on computed tomography | 2 months | Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
Countries
South Korea
Outcome results
None listed