NCT05199519已完成1 期
A Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345 in Patients With CLDN18.2-positive Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
研究概览
简要总结
A phase Ia study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy of IBI345 in patients with CLDN18.2 positive solid 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
- •Age ≥18 years and ≤75 years.
- •Histologically or cytologically confirmed CLDN18.2 positive patients with advanced gastric cancer or pancreatic cancer who failed standard therapy .
- •There are assessable lesions according to RECIST V1.1 (solid tumor efficacy evaluation criteria).
- •Expected survival time ≥12 weeks.
- •ECOG PS 0~1.
排除标准
- •Participating in another interventional clinical study, other than observational (non-interventional) clinical study or in the survival follow-up phase of the interventional study.
- •Received any antitumor drug within 2 weeks prior to apheresis or initial administration of the investigational drug.
- •Use of immunosuppressive drugs within 1 week prior to apheresis or 2 weeks prior to initial administration of the investigational drug.
- •Long-term systemic steroid or any other immunosuppressive drug therapy is required, not including inhaled steroid therapy.
- •Receive live attenuated vaccine within 4 weeks prior to initial administration of the study drug or plan to receive live attenuated vaccine during the study period.
- •Toxicity (excluding alopecia, fatigue, and hematological toxicity) that did not return to equal to or lower than Grade 1 of NCI CTCAE V5.0 from previous antitumor therapy prior to initial administration of the investigational drug.
研究组 & 干预措施
IBI345
Other
Single arm
干预措施: IBI345 (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
时间窗: up to 2 years
次要结局
- Objective Response Rate (ORR) according to RECIST version 1.1(up to 2 years)
- Duration of Response (DOR) according to RECIST version 1.1(up to 2 years)
- Overall Survival (OS) according to RECIST version 1.1(up to 2 years)
- Disease Control Rate (DCR) according to RECIST version 1.1(up to 2 years)
- Time to Response (TTR) according to RECIST version 1.1(up to 2 years)
- Progression-Free Survival (PFS) according to RECIST version 1.1(up to 2 years)
- Peak Plasma Concentration (Cmax)(up to 1 years)
- Time of maximum drug concentration in hours [Tmax](up to 1 years)
- Elimination half-life in hours [t1/2](up to 1 years)
- Clearance (CL)(up to 1 years)
- Distribution Volume (Vd)(up to 1 years)
- Area under theplasma concentration versus time curve (AUC)(up to 1 years)
- Number of Participants With anti-drug antibody (ADA)(up to 1 years)
- Number of Participants With Neutralizing Antibodies (NAbs)(up to 1 years)
研究者
研究点 (1)
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