A Phase I Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of treatment related AEs
研究概览
简要总结
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with hematologic malignancies who have failed standard treatment.
详细描述
This Phase 1a/1b study will be conducted to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of IBI322 in China. Phase 1a is a dose escalation and plans to enroll approximately 39-102 subjects with hematologic malignancies who have failed standard treatments. Phase 1b is a dose expansion and plans to enroll approximately 80 subjects with hematologic malignancies.
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 hematologic malignancy who failed the standard treatment
- •At least one evaluable lesion
- •Male or female 18 to 75 years old
- •Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0-2
- •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 chimeric antigen receptor T cell immunotherapy (CAR-T)
- •Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies
- •Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start
- •A history of blood transfusion within 2 weeks prior to study start
研究组 & 干预措施
IBI322
Single arm
干预措施: IBI322 (Biological)
结局指标
主要结局
Number of treatment related AEs
时间窗: Up to 90 days post last dose
Safety
Number of patients with response
时间窗: Last patient enrolled +24 weeks
Preliminary Efficacy
次要结局
- Positive Rate of ADA and Nab(Up to 90 days post last dose)
- PK Parameters: Maximum concentration (Cmax)(Up to 90 days post last dose)
- PK Parameters: Clearance (CL)(Up to 90 days post last dose)
- PK Parameters: Volume of Distribution (V)(Up to 90 days post last dose)
- PK Parameters: Half-life (t1/2)(Up to 90 days post last dose)
- PK Parameters: The area under the curve (AUC)(Up to 90 days post last dose)