A Multicenter Phase I Open-label Dose-escalation Vaccine Trial of dHER2 Protein With AS15 Adjuvant in HER2-overexpressing Patients With High-risk Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 18
- 主要终点
- Occurrence of solicited local and general signs and symptoms recorded by the patient on diary cards
研究概览
简要总结
Treatment phase:
The purpose of this study is to evaluate the safety and the immune response elicited by a new anti-cancer therapy in patients with breast cancer in remission but who are at high risk of relapse. The study product is an immunotherapeutic consisting of the recombinant dHER2 protein combined with an immunostimulant called AS15. The study aims to determine the optimal of three different dose levels of dHER2 combined with the same fixed dose of AS15 by assessing the safety and the immune response elicited after a series of injections of the study product.
Five-year follow-up phase:
This part of the study aims to assess any late onset toxicity of the study treatment through yearly follow-up visits and to monitor the patients' survival and disease status up to five years after the last administration of the study treatment. The patients' immune response is also measured to assess the robustness of the immune response elicited by the study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Occurrence of solicited local and general signs and symptoms recorded by the patient on diary cards
时间窗: Period of eight days (Day 0 to Day 7) immediately after each administration of the study treatment
Occurrence of cardiotoxicity
时间窗: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of serious adverse events
时间窗: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of dose limiting toxicity (DLT)
时间窗: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of unsolicited non-serious adverse events
时间窗: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Hematological, biochemical (including auto-immunity) and urinalysis parameters
时间窗: During the study period (until Week 40 or 43)
Occurrence of Grade 3 or 4 adverse events
时间窗: During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Changes in vital signs
时间窗: During the entire study period (until Week 40 or 43)
Physical examination findings
时间窗: During the study period (until Week 40 or 43)
次要结局
- Anti-dHER2, anti-HER2 ECD and anti-HER2 ICD seropositivity(Two weeks after the fourth and sixth study treatment administrations (Week 6 and Week 14) and at the three and six months follow-up visit (Week 26 and Week 40). At yearly visits during the five-year follow-up period)
- Anti-dHER2, anti-HER2 ECD (extracellular domain), anti-HER2 ICD (intracellular domain) antibody concentrations(Two weeks after the fourth and sixth study treatment administrations (Week 6 and Week 14) and at the three and six months follow-up visit (Week 26 and Week 40). At yearly visits during the five-year follow-up period)
- In vitro functional activity response (e.g. growth inhibition of HER2-overexpressing breast tumor cells) expressed as a percentage of inhibition(After four or six administrations of the study treatment)
- Antibody-dependent cellular cytotoxicity (ADCC, % of lysis) - optionally(After four or six administrations of the study treatment)
- In vitro cellular immune response to dHER2, HER2 ECD and HER2 ICD as shown by lymphoproliferative response (expressed by stimulation index) and by secretion of interferon-γ and interleukin-5 expressed by concentration (pg/mL)(At baseline, after Dose 4, after Dose 6, at six months follow-up visit)