NCT04651348招募中1 期
A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors
Beijing Mabworks Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年1月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Adverse Events
研究概览
简要总结
This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.
The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.
Part B will have 5 dose cohorts(3mg/kg QW, 10mg/kg QW, 20mg/kg QW 30mg/kg QW and 45mg/kg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.
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
- •Adult patients, >=18 years of age;
- •Diagnosis of Refractory/relapsed lymphomas or solid tumor;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Life expectancy >=3 months;
- •Sufficient organ and bone marrow function;
- •At least one measurable lesion or evaluable lesion (recist v1.1 or Lugano 2014);
- •Able and willing to provide written informed consent and to comply with the study protocol.
排除标准
- •Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;
- •Previous exposure to any drug targeting CD47 or SIRPα;
- •Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
- •Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;
- •Central nervous system metastasis;
- •History of other primary malignant tumors in 5 years;
- •Evidence of significant, uncontrolled concomitant disease;
- •Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
- •Active or suspected autoimmune diseases;
- •Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments;
- •Known history of hemolytic anemia;
- •Known severe allergic reaction or/and infusion reaction to monoclonal antibody.
研究组 & 干预措施
MIL95
Experimental
干预措施: Recombinant Humanized Monoclonal Antibody MIL95 (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events
时间窗: up to 1year after enrollment
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
次要结局
- Pharmacokinetics:AUC(up to 1year after enrollment)
- Pharmacokinetics: Cmax(up to 1year after enrollment)
- Objective response rate (ORR)(up to 1year after enrollment)
- Duration of response (DoR)(up to 1year after enrollment)
- Progression free survival (PFS)(up to 1year after enrollment)
- Immunogenicity(up to 1year after enrollment)
研究者
研究点 (1)
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