NCT07275242招募中1 期
An Open-Label, Multi-site Phase I Clinical Study of SHR-A1811(sc) Subcutaneous Injection: Evaluating Pharmacokinetics, Safety, Tolerability, and Efficacy in Patients With Solid Tumor
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Area under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc)
研究概览
简要总结
The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •≥18 years of age;
- •Solid Tumor confirmed by histology or cytology;
- •ECOG score is 0 or 1;
- •An expected survival of ≥ 12 weeks;
- •At least one measurable lesion according to RECIST v1.1 criteria;
- •Have adequate renal and hepatic function;
- •Patients voluntarily joined the study and signed informed consent.
排除标准
- •With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer;
- •Patients have major surgical procedures or radiotherapy / chemotherapy within 4 weeks before the first medication;
- •History of immunodeficiency;
- •Clinically significant cardiovascular diseases;
- •Known or suspected interstitial lung disease;
- •Known hereditary or acquired bleeding thrombotic tendency;
- •Active hepatitis and liver cirrhosis;
- •Known allergic history of the drug components of this protocol;
- •History of neurological or psychiatric disorders.
研究组 & 干预措施
Low-Dose Group
Experimental
干预措施: SHR-A1811 Subcutaneous Injection (Drug)
Low-Dose Group
Experimental
干预措施: SHR-A1811 for Injection (Drug)
Medium-Dose Group
Experimental
干预措施: SHR-A1811 Subcutaneous Injection (Drug)
Medium-Dose Group
Experimental
干预措施: SHR-A1811 for Injection (Drug)
High-Dose Group
Experimental
干预措施: SHR-A1811 Subcutaneous Injection (Drug)
High-Dose Group
Experimental
干预措施: SHR-A1811 for Injection (Drug)
结局指标
主要结局
Area under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc)
时间窗: About 72 weeks.
The incidence and severity of Dose-Limiting Toxicities (DLTs)
时间窗: About 72 weeks.
Adverse Events (AEs)
时间窗: About 72 weeks.
次要结局
- Anti-SHR-A1811 antibodies (ADA)(About 72 weeks.)
- Maximum concentration (Cmax)(About 72 weeks.)
- Trough concentration (Cmin)(About 72 weeks.)
- Objective Response Rate (ORR)(About 72 weeks.)
- Apparent clearance (CL/F)(About 72 weeks.)
- Maximum concentration at steady state (Css, max)(About 72 weeks.)
- Time to maximum concentration (Tmax)(About 72 weeks.)
- Elimination half-life (t1/2)(About 72 weeks.)
- Mean residence time (MRT)(About 72 weeks.)
- Apparent volume of distribution at steady state (Vss/F)(About 72 weeks.)
- Area under the concentration-time curve at steady state (AUCss)(About 72 weeks.)
- Accumulation ratio (Rac)(About 72 weeks.)
- Duration of Response (DoR)(About 72 weeks.)
- Disease Control Rate (DCR)(About 72 weeks.)
- Overall Survival (OS)(About 72 weeks.)
- Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)(About 72 weeks.)
- Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)(About 72 weeks.)
- Trough concentration at steady state (Css, min)(About 72 weeks.)
- Progression-Free Survival (PFS)(About 72 weeks.)
研究者
研究点 (1)
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