NCT05245916撤回1 期
A Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or Combination Therapies in Patients With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage of Subjects with Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
The primary objective of this phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or its Combination Therapies in Patients with Advanced Malignancies
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- •Has been previously exposed to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein or other inhibitors that target the same pathway
- •Is currently participating in another interventional study, except for observational (non-interventional) study or in the survival follow-up phase of an interventional study
- •Requires long-term systemic hormone or any other immunosuppressive drug therapy, excluding inhaled hormone therapy
- •Has acute or chronic active hepatitis B (defined as hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody positive [HBcAb] and hepatitis B virus [HBV] DNA copy number ≥ 1 × 104 copies/ml or ≥ 2000 IU/ml or higher than the lower limit of detection) or acute or chronic active hepatitis C virus (HCV) antibody positive; HCV antibody positive but RNA negative subjects are allowed
- •Has a known history of severe allergic reaction to other monoclonal antibodies, or is allergic to any component of the IBI397 formulation.
- •Is pregnant or breastfeeding
研究组 & 干预措施
IBI397 single-agent dose escalation
Experimental
干预措施: IBI397 (Drug)
IBI397+ Rituximab
Experimental
干预措施: IBI397 (Drug)
IBI397+ Rituximab
Experimental
干预措施: IBI397+Rituximab (Drug)
IBI397 + Sintilimab
Experimental
干预措施: IBI397 (Drug)
IBI397 + Sintilimab
Experimental
干预措施: IBI397+Sintilimab (Drug)
结局指标
主要结局
Percentage of Subjects with Dose-Limiting Toxicities (DLTs)
时间窗: Up to 28 Days following first dose
To evaluate the safety and tolerability of IBI397 alone or in combination with Sintilimab
Number of patients with treatment related AEs
时间窗: Up to 90 days post last dose
Number of patients who experienced a treatment related AEs from the frist dose until 90 days after the last dose
次要结局
- area under the plasma concentration-time curve (AUC)(Up to 90 days post last dose)
- maximum concentration (Cmax)(Up to 90 days post last dose)
- clearance (CL)(Up to 90 days post last dose)
- half-life (t1/2)(Up to 90 days post last dose)
- volume of distribution (V)(Up to 90 days post last dose)
- Objective response rate (ORR)(Up to 2 years after enrollment)
- anti-drug antibody (ADA)(Up to 90 days post last dose)
研究者
研究点 (1)
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