NCT02079324CompletedPhase 1
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Genexine, Inc.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- MTD after GX-051 intratumoral injection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Longest distance of the tumor is bigger than 1 cm and capable of Intratumoral injection.
- •Baseline ECOG Performance Status 0, 1 or
- •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.
Arms & Interventions
GX-051
Experimental
GX-051 intratumoral injection
Intervention: GX-051 (Biological)
Outcomes
Primary Outcomes
MTD after GX-051 intratumoral injection
Time Frame: 2 months
Secondary Outcomes
- Adverse events after GX-051 intratumoral injection(2 months)
- Evaluation of antibody generation against IL-12 which is active ingredient of GX-051(2 months)
- Evaluation of long term safety examined by vital sign, physical examination, clinical laboratory tests, CT etc(17 monthes)
- Anti-tumor response by RECIST 1.1 on computed tomography(2 months)
- Changes of INF-γ and IL-12 levels in blood comparing to the baseline after GX-051 intratumoral injection(2 months)
- Changes of immune cell distribution in tumor tissue after GX-051 intratumoral injection(2 months)
Investigators
Study Sites (1)
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