Open-label, Dose-escalation, Multiple Dosing Study to Evaluate the Safety, Tolerability, Immune Response and Pre Efficacy of BVAC-C in Patients With Multiple Metastatic Progressive or Recurrent HPV Type 16 or 18 Positive Cervical Cancer After Failure to Standard Care
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of Serious Adverse Events assessed with CTCAE [Safety]
研究概览
简要总结
BVAC-C is an immunotherapeutic vaccine using B-Cell and Monocytes as antigen-presenting cells. This study is consists of 2 parts. Phase I is for safety evaluation, and Phase IIa is for efficacy assessment.
详细描述
BVAC-C is an immunotherapeutic vaccine using B-Cell and Monocytes as antigen-presenting cells. This study is consists of 2 parts(Phase I, Phase II). Phase I study is Open-label, dose-escalation, multiple dosing study to evaluate the safety, tolerability, immune response and preliminary efficacy of BVAC-C in patients with multiple metastatic progressive or recurrent HPV type 16 or 18 positive cervical cancer after failure to standard care. 9~18 patients will be enrolled In Phase IIa study, which Open-label, sequential assignment multiple dosing study, efficacy, immune response and safety will be evaluated. Total 21 patients will be enrolled in 3 groups.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple metastatic progressive or recurrent HPV type 16 or 18 positive cervical cancer
- •Patients has received 1 or more platinum based doublet chemotherapy as prior therapy for progressive or recurrent tumor lesion (prior therapy does not include platinum chemotherapy given with radiation therapy for 1st line treatment before progression or recurrence)
- •Patients with at least 1 measurable lesion according to RECIST
- •Female patients between ages of 20 to 70
- •Patients with ECOG performance status between 0 to 2
- •Patients meets the blood test standards in the screening test
- •ANC≥1500/μL
- •LLN ≤ALC ≤ULN
- •Platelets≥100,000/μL
- •Hemoglobin> 9g/dL
- •Patients meets the blood chemistry test standards in the screening test
- •Serum creatinine ≤ 2.0 mg/dL
- •Calculated creatinine clearance ≥ 50 mL/min
- •Serum bilirubin ≤1.5 x ULN
- •ALT and AST ≤2.5 × ULN (≤ 5 x ULN in patients with liver metastases)
- •Patients who has agreed to a medically accepted contraceptive in this clinical trial
- •Patients at least three 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
- •Patients histopathology is a neuroendocrine or small cell carcinoma
- •Patients with a history of brain metastasis or signs of brain metastasis
- •Patients tested positive in serological tests for hepatitis C virus or hepatitis B virus surface antigen, (HBsAg) or human immunodeficiency virus (HIV)
- •Patients with a history of HIV infection
- •Patients showing abnormal electrocardiogram , including arrhythmia
- •Patients have been administered the drug for other clinical trials within 4weeks before the screening visit
- •Patients have been administered any vaccines within 4weeks before the screening visit (eg. hepatitis A, hepatitis B, influenza, Td, etc. )
- •Patients have been administered the blood products within 3 months before the screening visit
- •Patients have received chemotherapy or radiation therapy within 4weeks before the 1st administration of investigational drug (BVAC-C)
- •Patients treated with immunosuppressant or immunomodulatory agents within 6 months before the screening visit
- •Patients who have participated in the clinical trial of a therapeutic vaccine or immune therapy within 1 year before the screening visit
- •Patients with a history of serious allergic disease or serious side effects of the drug
- •Patients who is pregnant or breast-feeding
- •Patients researchers has determined that participation in the clinical trial is inappropriate
- •Patients suspected to have other primary cancer
研究组 & 干预措施
BVAC-C mono(High dose)
BVAC-C IV injection at 0, 4, 8th weeks.(HIgh dose)
干预措施: BVAC-C (Drug)
BVAC-C mono(Intermediate dose)
BVAC-C IV injection at 0, 4, 8, 12th weeks.(Half dose)
干预措施: BVAC-C (Drug)
BVAC-C + Topo Combi
BVAC-C IV injection at 0,4,8,12th weeks.(Half dose) Topotecan IV injection at 2, 6, 10, 14th weeks
干预措施: BVAC-C (Drug)
BVAC-C + Topo Combi
BVAC-C IV injection at 0,4,8,12th weeks.(Half dose) Topotecan IV injection at 2, 6, 10, 14th weeks
干预措施: Topotecan (Drug)
结局指标
主要结局
Incidence of Serious Adverse Events assessed with CTCAE [Safety]
时间窗: 12th week from first injection (End of trial)
Evaluate DLT with Clinical laboratory tests [Safety]
时间窗: 12th week from first injection (End of trial)
Lymphocyte subset, Serum cytokine, NKT/NK cell assay, CD4/CD8 assay
次要结局
- Clinical laboratory tests(Screening visit and every 2 weeks from first injection (up to 12th week))
- Vital signs(Every 2 weeks from first injection (up to 12th week))
- Physical examination(Screening, 6th week from first injection, 10th week from first injection and Termination visit (12th week from first injection))
- 12-lead ECG(Screening visit and Termination visit (12th week from first injection))