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) + Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- ORR
研究概览
简要总结
This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
- •Age ≥ 18 years and ≤ 75 years when ICF is signed;
- •Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
- •Arm A: never received systemic anti-tumor drug therapy before, with HER2 negative and PD-L1 CPS≥5; Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines);
- •Measurable lesion according to RECIST v1.1 by IRRC;
- •ECOG score 0-1;
- •Expected survival 12 weeks.
排除标准
- •Has other active malignancies within 5 years before the first administration of the study drug;
- •Plan to or have previously received organ or bone marrow transplantation;
- •Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- •Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.) and / or antibody drugs against EGFR; Arm B: previously received antibody drug treatment against EGFR;
- •Have received any research drugs within 14 days before the first use of the study drugs.
研究组 & 干预措施
Arm A
HER2 negative and PD-L1 CPS≥5, as first-line therapy
干预措施: HLX07+HLX10+oxaliplatin+capecitabine (Drug)
Arm B
As third-line or above therapy
干预措施: HLX07 (Drug)
结局指标
主要结局
ORR
时间窗: Up to 2 years
Objective response rate by IRRC assessment per RECIST 1.1
PFS
时间窗: From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
Progression-free survival by IRRC assessment per RECIST 1.1
次要结局
- OS(From the date of first dose unitl the date of death from any cause，assessed up to 2 years)
- ORR(Up to 2 years)
- DOR(From the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years)
- PFS(From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years)