NCT06710990已完成1 期
A Multicenter, Open-label, Fixed-sequence Study to Evaluate Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer
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
- 17
- 试验地点
- 2
- 主要终点
- The maximum concentration (Cmax) for SHR-A1811
研究概览
简要总结
The study is being conducted to evaluate the pharmacokinetics and safety of SHR-A1811 monotherapy and in combination with Ritonavir or Itraconazole in subjects with HER2-expressing advanced breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG score of 0 or 1;
- •Expected survival of not less than 3 months;
- •Important organ functions meet the following criteria:
- •Absolute neutrophil count (ANC) ≥1.5×109/L (1,500/mm3);
- •Platelet count (PLT) ≥100×109/L (100,000/mm3);
- •Hemoglobin (Hgb) ≥9.0 g/dL (90g/L);
- •Albumin level ≥3.0 g/dL;
- •Total serum bilirubin ≤1.5× the upper limit of normal (ULN);
- •Prothrombin time and activated partial thromboplastin time (aPTT) ≤1.5×ULN;
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for patients with liver metastasis, ALT and AST ≤5×ULN);
- •Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min;
- •QTcF ≤470 msec;
- •Left ventricular ejection fraction (LVEF) ≥50%.
排除标准
- •Known active central nervous system metastases that have not been treated with surgery or radiation, except those that have been stable for at least 1 month after treatment and have discontinued corticosteroids for >2 weeks;
- •Having cardiac diseases, such as severe/unstable angina, symptomatic congestive heart failure (NYHA II-IV), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, myocardial infarction within 6 months before the first administration, etc.
- •Known severe allergic history to any component of the SHR-A1811 product (ADC, total antibody, unconjugated toxin SHR169265 or its excipients), or hypersensitivity to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.);
- •Having contraindications to ritonavir or itraconazole use;
- •Having one or more factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, partial or total gastrectomy, etc.), or having active gastrointestinal diseases or other diseases that may significantly affect drug absorption, distribution, metabolism, or excretion.
研究组 & 干预措施
Cohort 1: SHR-A1811 + Ritonavir
Experimental
干预措施: Ritonavir (Drug)
Cohort 2: SHR-A1811 + Itraconazole
Experimental
干预措施: SHR-A1811 (Drug)
Cohort 1: SHR-A1811 + Ritonavir
Experimental
干预措施: SHR-A1811 (Drug)
Cohort 2: SHR-A1811 + Itraconazole
Experimental
干预措施: Itraconazole (Drug)
结局指标
主要结局
The maximum concentration (Cmax) for SHR-A1811
时间窗: Cycle 2 and Cycle 3. Each cycle is 21 days.
The maximum concentration (Cmax) for payload
时间窗: Cycle 2 and Cycle 3. Each cycle is 21 days.
Area under the concentration curve from time 0 to 16 days (AUC0-16d) for SHR-A1811
时间窗: Cycle 2 and Cycle 3. Each cycle is 21 days.
Area under the concentration curve from time 0 to 16 days (AUC0-16d) for payload
时间窗: Cycle 2 and Cycle 3. Each cycle is 21 days.
次要结局
- Time to maximum plasma concentration (Tmax)(Cycle 2 and Cycle 3. Each cycle is 21 days.)
- Terminal half-life (t1/2)(Cycle 2 and Cycle 3. Each cycle is 21 days.)
- Area under the concentration curve from time 0 to infinity (AUCinf)(Cycle 2 and Cycle 3. Each cycle is 21 days.)
- Clearance (CL)(Cycle 2 and Cycle 3. Each cycle is 21 days.)
- Volume of distribution at steady state (Vss)(Cycle 2 and Cycle 3. Each cycle is 21 days.)
- Incidence and severity of adverse events(From the beginning of screening period to approximately 3 months after the last dose.)
研究者
研究点 (2)
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