Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination with Oxaliplatin and Capecitabine (XELOX) in First-line Treatment of Unresectable Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.
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
- •Male or female subjects, ≥ 18 years and ≤75 years.
- •Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.
- •Subjects with at least one measurable lesion according to RECIST v1.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
- •Expected survival time ≥ 3 months.
排除标准
- •Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
- •Active uncontrolled bleeding or a known bleeding diathesis.
- •Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
研究组 & 干预措施
Cohort 1
IBI363 combination with oxaliplatin and capecitabine (XELOX) for first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma
干预措施: IBI363 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Through out the study (up to 2 years)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Disease control rate (DCR)
时间窗: Through out the study (up to 2 years)
The efficacy of solid tumors was evaluated according to RECIST v1.1
次要结局
- Progression Free Survival（PFS）;(Up to 2 years)
- Overall Survival, OS）(Up to 2 years)
- Adverse Enent (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)(Up to 90 days after the last administration)
研究者
Xiangdong Cheng
Secretary of the party committee
Zhejiang Cancer Hospital