A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs)
研究概览
简要总结
This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients.
The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75, Male and female participants
- •Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction;
- •HER2 expression ;
- •Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients;
- •The expected survival ≥3 months;
- •Sufficient bone marrow and organ functions;
排除标准
- •There were ascites, pleural effusion and pericardial effusion that needed to be treated;
- •Major surgery was performed within 4 weeks;
- •Have active autoimmune disease or history of autoimmune disease;
- •Patients with interstitial pneumonia;
- •There was severe infection within 4 weeks before starting the study treatment;
- •Patients with active pulmonary tuberculosis infection history within 1 year before enrollment;
- •Serious cardiovascular and cerebrovascular diseases;
- •Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;
研究组 & 干预措施
Arm 1A: SHR-A1811 and SHR-1701
干预措施: SHR-A1811 and SHR-1701 (Drug)
Arm 1B: SHR-A1811 and capecitabine
干预措施: SHR-A1811 and capecitabine (Drug)
Arm 1C: SHR-A181, SHR-1701, and capecitabine
干预措施: SHR-A181, SHR-1701, and capecitabine (Drug)
Arm 1D: SHR-A1811, SHR-1316, and capecitabine
干预措施: SHR-A1811, SHR-1316, and capecitabine (Drug)
Arm 1F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin
干预措施: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin (Drug)
Arm 1G: SHR-A1811, SHR-1316, and 5-FU
干预措施: SHR-A1811, SHR-1316, and 5-FU (Drug)
Arm 2A: SHR-A1811, SHR-1316, and capecitabine
干预措施: SHR-A1811, SHR-1316, and capecitabine (Drug)
Arm 2B: SHR-1316 and SHR-A181
干预措施: SHR-1316 and SHR-A1811 (Drug)
Arm 2C: SHR-A1811 and capecitabine
干预措施: SHR-A1811 and capecitabine (Drug)
Arm 2D: SHR-A1811, SHR-1316, and 5-FU
干预措施: SHR-A1811, SHR-1316, and 5-FU (Drug)
Arm 2E: SHR-A1811and 5-FU
干预措施: SHR-A1811and 5-FU (Drug)
Arm 2F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin
干预措施: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin (Drug)
结局指标
主要结局
Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs)
时间窗: Safety will be assessed for approximately 24 months from informed consent
Phase II: Objective Response Rate (ORR)[
时间窗: An average of approximately 12 months
次要结局
- ORR（Phase Ib）(An average of approximately 12 months)
- DoR（Phase II）(An average of approximately 18 months)
- DoR（Phase Ib）(An average of approximately 18 months)
- PFS（Phase Ib）(An average of approximately 18 months)
- OS（Phase Ib）(An average of approximately 30 months)
- PFS（Phase II）(An average of approximately 18 months)
- OS（Phase II）(An average of approximately 30 months)
- Occurrence of adverse events (AEs), and serious adverse events (SAEs) （Phase II）(Safety will be assessed for approximately 24 months from informed consent])