A Multi-center Study of hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse Post Definitive Surgery and Standard Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 12
- 主要终点
- Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site
研究概览
简要总结
This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of ten treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written IRB approved informed consent;
- •Males or females aged ≥18 years;
- •Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitive therapy at the time of signing informed consent as described below for each indication:
- •Breast carcinoma:
- •Lung carcinoma:
- •Pancreatic carcinoma:
- •Head and neck squamous cell carcinoma:
- •Ovarian cancer:
- •Colorectal cancer
- •Gastric and esophageal cancer
- •Hepatocellular carcinoma
排除标准
- •Previous treatment wth any TERT or IL-12 containing therapy, or any other DNA immunotherapy;
- •Any concurrent condition requiring the continued or anticipated use of systemic steroids (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids) or immunosuppressive therapy (excludes low dose methotrexate). All other systemic corticosteroids must be discontinued at least 4 weeks prior to first Study Treatment;
- •Administration of any vaccine within 4 weeks of the first study treatment
研究组 & 干预措施
Arm 3
2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-1400 (Biological)
Arm 6
8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-1400 (Biological)
Arm 10
8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-1401 (Biological)
Arm 9
8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-9012 (Biological)
Arm 5
8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-1400 (Biological)
Arm 1
2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-1400 (Biological)
Arm 2
8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-1400 (Biological)
Arm 8
8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-1401 (Biological)
Arm 7
2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-1401 (Biological)
Arm 6
8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-9012 (Biological)
Arm 4
2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-1400 (Biological)
Arm 10
8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-9012 (Biological)
Arm 3
2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-9012 (Biological)
Arm 9
8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-1401 (Biological)
Arm 5
8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-9012 (Biological)
Arm 4
2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
干预措施: INO-9012 (Biological)
结局指标
主要结局
Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site
时间窗: Up to 14 weeks
Changes in safety laboratory parameters
时间窗: Up to 2 years from first study treatment
Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
时间窗: Up to 2 years from first study treatment
次要结局
未报告次要终点