An Open Phase I Clinical Study Assessing Safety and Tolerability of MVX-ONCO-1 in Patients With Solid Tumor Who Are Not/Not Any Longer Amenable to Standard Therapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of patients with Adverse Events and/or Serious Adverse Events
研究概览
简要总结
The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1, administered sub-cutaneously (injections and capsules implantations), in patients with advanced metastatic solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease.
详细描述
Endpoints:
Primary: To assess safety parameters including adverse and serious adverse events (incidence, causality, severity), local and systemic tolerance to the administered study treatment, changes in laboratory values and vital signs in patients with solid tumor; Secondary: to measure some tumor responses in using imaging technique, serological tumor markers, immune monitoring and metabolic monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male or female patients aged 18 years and older with advanced metastatic cancer in progression of various sites [Carcinoma of lung (either small cell or non-small cell), colon, breast, pancreas (exocrine or endocrine), stomach, oesophagus, head&neck, thyroid, kidney, bladder, prostate, ovary, uterus (cervix or corpus); Sarcoma of soft tissue, bone, uterus, melanoma; primary brain tumor] where all recognized treatment are exhausted or not feasible.
- •Life expectancy: estimate of at least 4 months.
排除标准
- •Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks.
- •Have received any chemotherapy treatment in the 4 preceding weeks.
- •Serious concomitant health condition such as organ transplant requiring immunosuppressive drugs, severe psychiatric disorders.
- •History of second cancer within the last 2 years with the exception of basal cell carcinoma of skin and localized cervical carcinoma treated with curative intent.
- •Patient with a systemic disease other than cancer, that is not controlled by usual medication.
- •Therapeutic anticoagulation with coumarine or continues iv heparin. Low-molecular weight heparin (LMWH) is permitted as long as treatment can be withheld several hours prior to subcutaneous implantation.
- •Positive HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B surface antigen, or hepatitis C antibody.
研究组 & 干预措施
treatment
MVX-1-loaded capsules and injection of irradiated autologous tumor cells
干预措施: Treatment (Other)
结局指标
主要结局
Number of patients with Adverse Events and/or Serious Adverse Events
时间窗: 18 weeks
Adverse events will be followed carefully at each clinic visit by the Investigator, to determine their incidence, causality and severity.
次要结局
- Delayed type hypersensitivity reactions, Induction of a specific CD8 response(18 weeks)
- imaging and metabolic monitoring(18 weeks)
- tumor size(18 weeks)
- tumor pain(18 weeks)