Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.
试验速览
- 阶段
- 1 期
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose(MTD) of Mogamulizumab
研究概览
简要总结
The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T cell depletion with Mogamulizumab for advanced or recurrent cancer patients.
详细描述
This study consists of phase Ia and Ib portions for patients with solid tumors.
Phase Ia portion is the standard 3+3 dose-escalation design with 0.1mg/kg, 0.5mg/kg and 1.0mg/kg of Mogamulizumab.
Phase Ib portion is the randomized study comparing 0.1mg/kg and tolerated dose of Mogamulizumab based on the phase Ia portion to pursue safer and immunologically more efficient dose.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed, CCR4 negative lung, stomach, esophageal, ovarian or skin cancer.
- •Patients with therapy-resistant cancer. Patients with recurrent cancer or advanced cancer who refused standard therapies.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or
- •Patients should be 20 years or older at the time of informed consent.
- •No serious dysfunction of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ; 1) WBC count : >=1,500/mm3 2) Hemoglobin : >=8.0g/dL 3) Platelet count : >=75,000/mm3 4) Serum total bilirubin : <=2.0 x ULN 5) AST and ALT : <=2.5 x ULN (Patients with hepatic infiltration which is attributed to primary disease<=5.0 x ULN) 6) Serum creatinine : <=1.5 mg/dL 7) SpO2 : >=93 % 8) ECG : No abnormal findings. 9) EF : >=50 %
- •Agree to use birth control including condom etc. from the time of obtaining the first consent to 24 weeks after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization).
- •Given written informed consent.
- •Patients who can be hospitalized from the day of first administration to the next day.
- •Patients who have target lesions measurable by RECIST ver.1.
- •Life expectancy >= 3 months.
排除标准
- •Patients with HIV antibody positive.
- •Patients with HCV antibody positive.
- •Patients with autoimmune disease.
- •Patients with HBs antigen or HBV-DNA positive.
- •History of serious anaphylaxis induced by antibody preparation.
- •Patients with double cancer.
- •Within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease.
- •Pregnant or breast-feeding females and females who have a possibility of pregnancy.
- •Patients with active infection.
- •Patients with psychosis or dementia.
- •Patients who need continuous systemic administration of adrenocorticosteroid.
- •Patients who have received hematopoietic stem cell transplantation.
- •Patients who have presence or suspicion of CNS involvement.
- •Patients who are administered the other investigational product within 4 weeks of the entry.
- •Patients treated with immunotherapy for cancer (e.g. cancer vaccine therapy) within 12 weeks of the entry.
- •Any other inadequacy for this study.
结局指标
主要结局
Maximum tolerated dose(MTD) of Mogamulizumab
时间窗: from first administration until day 28
Dose limiting toxicity(DLT) of Mogamulizumab
时间窗: from first administration until day 28
Number of adverse events
时间窗: from first administration to 24 weeks after the final administration, an expected average of 32 weeks.
Cmax of Mogamulizumab
时间窗: from day 0 to 28 days after the final administration, an expected average of 12 weeks.
Ctrough of Mogamulizumab
时间窗: from day 0 to 28 days after the final administration, an expected average of 12 weeks.
AUC0-7day of Mogamulizumab
时间窗: from day 0 to 28 days after the final administration, an expected average of 12 weeks.
Rate of Treg decrease in PBMC compared to baseline
时间窗: from baseline to every 4 weeks until data cut off
次要结局
- Objective tumor response rate according to RECIST(from baseline to every 12 weeks, until data cut off)
- Median progression free survival rate(from baseline to every 12 weeks, until data cut off (expected date is March 2016))
- Median Overall survival rate(from baseline to every 12 weeks, until data cut off)
研究者
Ryuzo Ueda, MD
Aichi Medical University
Aichi Medical University