This trial is active, not recruiting.

Condition head and neck cancer
Treatment gx-051
Phase phase 1
Sponsor Genexine, Inc.
Start date March 2014
End date September 2016
Trial size 12 participants
Trial identifier NCT02079324, GX-051_HNC_1


The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after intratumoral injection in head and neck cancer patience.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
GX-051 intratumoral injection
intratumoral injection

Primary Outcomes

MTD after GX-051 intratumoral injection
time frame: 2 months

Secondary Outcomes

Adverse events after GX-051 intratumoral injection
time frame: 2 months
Anti-tumor response by RECIST 1.1 on computed tomography
time frame: 2 months
Changes of INF-γ and IL-12 levels in blood comparing to the baseline after GX-051 intratumoral injection
time frame: 2 months
Changes of immune cell distribution in tumor tissue after GX-051 intratumoral injection
time frame: 2 months
Evaluation of antibody generation against IL-12 which is active ingredient of GX-051
time frame: 2 months
Evaluation of long term safety examined by vital sign, physical examination, clinical laboratory tests, CT etc
time frame: 17 monthes

Eligibility Criteria

Male or female participants at least 19 years old.

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.

Additional Information

Official title A Single Center, Open-Label, Accelerated Titration, Dose-Escalating, Phase Ι Study to Evaluate the Safety and Tolerability of IT Injection GX-051, Stem Cell Based Gene Therapeutics in Patients With Very Advanced Head and Neck Cancer
Principal investigator Minsik Kim, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Genexine, Inc..