An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- ORR
研究概览
简要总结
This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with 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
- •Age>=18Y and ≤75Y
- •Good Organ Function
- •Expected survival time ≥ 3 months
- •mCRC that have been diagnosed histologically
- •KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue
- •ECOG score 0-1;
排除标准
- •HIV infection
- •Active clinical severe infection;
- •A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
研究组 & 干预措施
A：1L treatment
HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W
干预措施: HLX07 (Drug)
A：1L treatment
HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W
干预措施: HLX10 (Drug)
A：1L treatment
HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W
干预措施: mFOLFOX6 (Drug)
B：≥2L treatment
HLX07 *1000 mg monotherapy,IV, Q2W
干预措施: HLX07 (Drug)
结局指标
主要结局
ORR
时间窗: up to 3 years
Objective response rate (assessed by investigator per RECIST V1.1)
PFS
时间窗: : from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years
Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 )
次要结局
- OS(up to 5 years)