NCT04328831已完成1 期
A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Number of DLT
研究概览
简要总结
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
详细描述
Phase 1a/Ib study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose escalation and plans to enroll approximately 38-60 subjects with advanced malignant solid tumors who failed the standard treatment. Phase Ib is dose expansion, and plans to enroll approximately 180 subjects with advanced malignant 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
- •At least one evaluable lesion.
- •Male or female subject above 18 years old, no more than 75 years old.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or
- •Must have adequate organ function
排除标准
- •Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- •Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) /anti-programmed death ligand 2 (PD-L2) antibodies
- •Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
- •Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)
- •Subjects who have a history of blood transfusion within 2 weeks prior to the study.
结局指标
主要结局
Number of DLT
时间窗: 28 days
Number of patients with response
时间窗: Last patient enrolled+24 weeks
Number of treatment related AEs
时间窗: 90 days post last dose
次要结局
- PK parameters: The area under the curve (AUC)(Up to 90 days post last dose)
- PK parameters: Maximum concentration (Cmax)(Up to 90 days post last dose)
- PK parameters: Time at which maximum concentration (Tmax)(Up to 90 days post last dose)
- Positive rate of Circulating Immune Complex(Up to last dose)
- PK parameters: The half-life (t1/2)(Up to 90 days post last dose)
- Positive rate of ADA and Nab(Up to 90 days post last dose)
研究者
研究点 (1)
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