A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 as First-Line Treatment in Metastatic Colorectal Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This study includes two parts:Part 1: SSGJ-707 (different dosing regimens) in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.Part 2: SSGJ-707 in combination with chemotherapy versus bevacizumab in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and/or females over age 18
- •Histologically and/or cytologically documented metastatic colorectal cancer confirmed .
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Expected survival >=12 weeks.
- •Signed informed consent form.
排除标准
- •Known uncontrolled or symptomatic central nervous system metastatic disease.
- •Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0).
- •Inadequate organ or bone marrow function.
- •Pregnant or breast-feeding woman.
- •Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
SSGJ-707(dose 2)+ mFOLFOX6
干预措施: 5-fluorouracil (Drug)
SSGJ-707+XELOX/mFOLFOX6
干预措施: SSGJ-707 (Drug)
SSGJ-707(dose 2)+ XELOX
干预措施: Oxaliplatin (Drug)
SSGJ-707(dose 1)+ XELOX
干预措施: SSGJ-707 (Drug)
SSGJ-707(dose 1)+ XELOX
干预措施: Oxaliplatin (Drug)
SSGJ-707(dose 1)+ XELOX
干预措施: Capecitabine (Drug)
SSGJ-707(dose 1)+ mFOLFOX6
干预措施: SSGJ-707 (Drug)
SSGJ-707(dose 1)+ mFOLFOX6
干预措施: Oxaliplatin (Drug)
SSGJ-707(dose 1)+ mFOLFOX6
干预措施: Calcium Folinate (Drug)
SSGJ-707(dose 2)+ mFOLFOX6
干预措施: Calcium Folinate (Drug)
SSGJ-707(dose 1)+ mFOLFOX6
干预措施: 5-fluorouracil (Drug)
SSGJ-707(dose 2)+ XELOX
干预措施: SSGJ-707 (Drug)
SSGJ-707(dose 2)+ XELOX
干预措施: Capecitabine (Drug)
SSGJ-707(dose 2)+ mFOLFOX6
干预措施: SSGJ-707 (Drug)
SSGJ-707(dose 2)+ mFOLFOX6
干预措施: Oxaliplatin (Drug)
SSGJ-707+XELOX/mFOLFOX6
干预措施: Oxaliplatin (Drug)
SSGJ-707+XELOX/mFOLFOX6
干预措施: Capecitabine (Drug)
SSGJ-707+XELOX/mFOLFOX6
干预措施: Calcium Folinate (Drug)
SSGJ-707+XELOX/mFOLFOX6
干预措施: 5-fluorouracil (Drug)
Bevacizumab+XELOX/mFOLFOX6
干预措施: Bevacizumab (Drug)
Bevacizumab+XELOX/mFOLFOX6
干预措施: Oxaliplatin (Drug)
Bevacizumab+XELOX/mFOLFOX6
干预措施: Capecitabine (Drug)
Bevacizumab+XELOX/mFOLFOX6
干预措施: Calcium Folinate (Drug)
Bevacizumab+XELOX/mFOLFOX6
干预措施: 5-fluorouracil (Drug)
SSGJ-707 monotherapy
干预措施: SSGJ-707 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 12 months
Safety and tolerability assessed by incidence and severity of adverse events
ORR
时间窗: 12 months
Objective response rate
次要结局
- PFS(24 months)