NCT03842085招募中1 期
Evaluation on Open-Labeled and Dose-Escalation Phase I Clinical Study of Safety and Pharmacokinetics of Recombinant Humanized Bispecific Monoclonal Antibody MBS301 for Injection in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
Beijing Mabworks Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年4月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- DLT of MBS301
研究概览
简要总结
This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors
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
- •Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology.
- •Patients with any types of malignant solid tumors who have progressed despite standard therapy or are intolerant of standard therapy, or for which no standard therapy exists.
- •Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1).
- •ECOG physical condition: 0 or 1 point.
- •Expected survival period exceeds 12 weeks.
排除标准
- •Absolute neutrophils count (ANC) is less than1.5×109/L and/or blood platelets less than 100 ×109/L and/or hemoglobin less than 9g/dL.
- •Total bilirubin is more than 1.5 ×ULN.
- •Patients without hepatic metastasis, ALT or AST is more than 1.5 ×ULN; Patients with hepatic metastasis, ALT or AST is more than 3 ×ULN.
- •Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance <50 mL/min(according to Cockcroft-Gault).
- •International normalized ratio (INR) is more than 1.5 × ULN or activated partial thromboplastin time (APTT) is more than 1.5 × ULN.
- •Patient has prior treated with anthracyclineswhich accumulated dose is equivalent to adriamycin≥360mg/m
- •Patient has been experienced toxic reactions after previous anticancer therapy and has not recovered to Grade 0 or Grade 1 (except for hair loss).
- •Known a history with brain metastasis.
- •Have a history of liver disease of clinical significance.
- •Known to be human immunodeficiency virus (HIV) positive.
研究组 & 干预措施
MBS301
Experimental
Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301
干预措施: Recombinant Humanized Bispecific Monoclonal Antibody MBS301 (Drug)
结局指标
主要结局
DLT of MBS301
时间窗: up to the third treatment cycle of the last subject was ended (each cycle is 21 days)
Evaluate the safety of MBS301 and determine the dose limited toxicity (DLT) .
MTD of MBS301
时间窗: up to the third treatment cycle of the last subject was ended (each cycle is 21 days)
Evaluate the safety of MBS301 and determine the maximum tolerated dose (MTD).
次要结局
- Evaluate the objective response rate (ORR)of MBS301(up to approximately 2 years)
- Investigate the pharmacokinetics profile(Cmax) of MBS301(At the end of Cycle 3 (each cycle is 21 days))
- Investigate the pharmacokinetics profile(MRT) of MBS301(At the end of Cycle 3 (each cycle is 21 days))
- Investigate the pharmacokinetics profile(Tmax) of MBS301(At the end of Cycle 3 (each cycle is 21 days))
- Investigate the pharmacokinetics profile(Vd) of MBS301(At the end of Cycle 3 (each cycle is 21 days))
- Investigate the pharmacokinetics profile(CL) of MBS301(At the end of Cycle 3 (each cycle is 21 days))
- Evaluate the progression free survival (PFS) of MBS301(up to approximately 2 years)
- Evaluate the duration of response (DoR) of MBS301(up to approximately 2 years)
- Evaluate the disease control rate (DCR) of MBS301(up to approximately 2 years)
- Investigate the pharmacokinetics profile(T1/2) of MBS301(At the end of Cycle 3 (each cycle is 21 days))
- Investigate the pharmacokinetics profile(AUC) of MBS301(At the end of Cycle 3 (each cycle is 21 days))
- Evaluate the immunogenicity of MBS301(screening, before the second/third cycle of administration, Cycle 1 day 15, at the end of Cycle 3 (each cycle is 21 days))
研究者
研究点 (1)
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