NCT00647114已完成1 期
A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V930/V932 in Patients With Cancer Expressing HER-2 and/or CEA
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- To determine the safety and tolerability of V930/V932 followed by EP in cancer patients
研究概览
简要总结
Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.
详细描述
The optional followup period for this study is 1 year after the last vaccination.
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
- Treatment
- 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
- •Patients must have completed surgical treatment for his/her primary disease at least 1 month prior to enrollment
- •Patient must not be pregnant 3 days prior to enrollment
排除标准
- •Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
- •Patient has had their spleen removed or has a history of autoimmune disorders
- •Patient is a regular user of any illicit drugs or has used within the past year of drug or alcohol abuse
- •Patient is pregnant or breastfeeding or is expecting to conceive anytime following the study
- •Patient is known to be Human Immunodeficiency Virus (HIV)-seropositive
- •Patient has a known history of Hepatitis B or C
- •Patient has received a vaccine for any disease or condition within one month of enrollment
- •Patient has a primary central nervous system tumor.
研究组 & 干预措施
1
Experimental
V930
干预措施: V930 (Biological)
2
Experimental
V932
干预措施: V932 (Biological)
结局指标
主要结局
To determine the safety and tolerability of V930/V932 followed by EP in cancer patients
时间窗: Week 22
次要结局
- To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay(Week 22)
研究者
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