NCT03425773已完成1 期
Single Center, Open-label, Accelerated Titration, Multiple Dosing Study to Evaluate the Safety, Tolerability, Immune Response and Pre-efficacy of BVAC-B in Patients With Progressive or Recurrent HER2/Neu Positive Gastric Cancer After Failure to Standard Care
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Evaluate Maximum tolerated dose(MTD) for phase 2 trial
研究概览
简要总结
BVAC-B is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell. This study is Open-label, Accelerated titration, Multiple dosing study to evaluate the safety, tolerability, immune response and pre-efficacy of BVAC-B in patients with progressive or recurrent HER2/neu positive gastric cancer after failure to standard care. 9-27 patients will be enrolled.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Progressive or recurrent HER2/neu positive(IHC 1+≥) gastric cancer
- •Received 1 or more chemotherapy or radiotherapy as prior therapy for progressive or recurrent tumor lesion
- •At least 1 measurable lesion according to RECIST(ver 1.1)
- •Ages above 19
- •ECOG performance status between 0 to 2
- •Patients meets the blood test standards in the screening test
- •Patients meets the blood chemistry test standards in the screening test
- •Patients who has agreed to a medically accepted contraceptive in this clinical trial
- •Patients at least six months or more of survival can be expected
- •Patients decided to participate in this clinical trial and signed written informed consent
排除标准
- •Histopathology is a neuroendocrine or small cell carcinoma
- •History of brain metastasis or signs of brain metastasis
- •Clinical diagnosis of hepatitis C or hepatitis B
- •Clinical diagnosis of human immunodeficiency virus (HIV)
- •History of HIV infection
- •Patients with heart failure, coronary artery disease(CAD) or Myocardial infarction in 6 month prior to screening. (LVEF is lower than 50% in screening visit)
- •Administered the drug for other clinical trials within 4weeks before participate in this trial
- •Administered any vaccines within 4weeks before participate in this trial (4 weeks for live vaccine, 2 weeks for other inactivated vaccine)
- •Administered the granulocytes concentrates within 3 months before the screening visit
- •Received chemotherapy or radiation therapy within 2 weeks before the 1st administration of investigational drug(BVAC-B)
- •Received following formulation within 1 months before the screening visit : Chronic steroids(more than 5 days), immunosuppressant or immunomodulatory agents. G-CSF
- •Patients who have participated in the clinical trial of a immunotherapeutic vaccine within 1 year or immunotherapy within 3 months before the screening visit
- •Patients who is pregnant or breast-feeding
- •Patients who researchers has determined that participation in the clinical trial is inappropriate
- •Suspected to have other progressive cancer or malignant tumor needs treatment in 3 years. Completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma, cervical intraepithelial neoplasia are not included
结局指标
主要结局
Evaluate Maximum tolerated dose(MTD) for phase 2 trial
时间窗: End of Dose-escalation stage(7 month from study start, Estimated)
Find Serious adverse drug reaction(Grade 3)
Incidence of Serious Adverse Events assessed with CTCAE v4.03
时间窗: 14th week from first injection
Evaluate safety and tolerability
次要结局
- Serum cytokine(Screening visit, Visit 2 (0 week) , visit 4 (4 week) ,visit 5 (6 week), visit 6 (8 week), visit 8(12 week), Termination visit(16 week))
- HER2/neu specific antibody(Screening visit, every 2 weeks after 1st injection(till 16th week))
- NKT/NK cell assay(Screening visit, every 24hr after injection(up to 12th week))
- CD4/CD8 assay(Screening visit, every 2 weeks after 1st injection(up to 16th week))
- Lymphocyte subset(Screening visit, visit 4 (4 week), visit 6 (8 week), visit 8 (12 week), termination visit (16 week))
- Change of tumor burden(Screening visit, Termination visit(16th week))
研究者
研究点 (2)
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