NCT04912466已完成1 期
A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of treatment related AEs
研究概览
简要总结
The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia.
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.
- •Per RECIST1, at least one evaluable or measurable 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.
- •Direct coombs test was positive or have history of hemolytic anemia.
- •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 treatment related AEs
时间窗: up to 90 days post last dose
Number of DLT
时间窗: 21 Days
Number of patients with response
时间窗: Last patient enrolled+24 months
次要结局
- the distribution volumn (Vd)(Up to 90 days post last dose)
- half-life period(t1/2)(Up to 90 days post last dose)
- Peak Plasma concentration(Cmax)(Up to 90 days post last dose)
- positive rate of ADA&NAB(from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months.)
- Reticulocyte count (RET)(Up to 90 days post last dose)
- Biomarker evaluation(from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months.)
- Area under the plsma concentration versus time curve(AUC)(Up to 90 days post last dose)
- Clearance rate(CL)(Up to 90 days post last dose)
- Percentage of receptor occupancy(Up to 90 days post last dose)
- Hemoglobin level(Up to 90 days post last dose)
- platelet count (PLT)(Up to 90 days post last dose)
研究者
研究点 (1)
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