An Open-Label, Multi-Center Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Number of subjects with laboratory tests findings of potential clinical importance
研究概览
简要总结
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content
- •Male or female
- •Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy
- •ECOG performance status of 0-1
排除标准
- •Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites
- •Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression
- •Has known history of other documented malignancy
- •Has known history of acquired immunodeficiency syndrome (AIDS)
- •Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade ≥ 2 cardiac failure
- •Has active or prior documented interstitial pneumonia/interstitial lung disease
- •Has experienced Grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose
- •Has known active hepatitis B
- •Has known allergies to SHR-1921 component
- •Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.
研究组 & 干预措施
SHR-1921
干预措施: SHR-1921 (Drug)
结局指标
主要结局
Number of subjects with laboratory tests findings of potential clinical importance
时间窗: Screening up to study completion, an average of 1 year
To check the Clinically significant and non clinically significant abnormal values during the course of trial.
Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate.
时间窗: Screening up to study completion, an average of 1 year
To measure the vital signs on regular basis for all study participants
Measure ECG
时间窗: Screening up to study completion, an average of 1 year
Number of subjects with clinically significant abnormal ECG QT Interval
Number of subjects with adverse events (AEs)
时间窗: Screening up to study completion, an average of 1 year
To check the numbers of AEs happened during the course of trial.
次要结局
- Maximum observed plasma concentration (Cmax) of SHR-1921(Screening up to study completion, an average of 1 year)
- Clearance of SHR-1921(Screening up to study completion, an average of 1 year)
- Terminal elimination half-life (t1/2) of SHR-1921(Screening up to study completion, an average of 1 year)
- Pharmacodynamics ("ADA" ) of SHR-1921.(Screening up to study completion, an average of 1 year)
- Time to Cmax (Tmax) of SHR-1921(Screening up to study completion, an average of 1 year)
- Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of SHR-1921(Screening up to study completion, an average of 1 year)