A Multicenter, Open and Phase II Clinical Study of HX008 for the Treatment in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 123
- 试验地点
- 30
- 主要终点
- ORR of HX008 combined with irinotecan and HX008 single drug
研究概览
简要总结
In this study, patients of advanced gastric adenocarcinoma with failed first-line chemotherapy-line or advanced mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) advanced solid carcinoma will be treated with HX008 combined with irinotecan and HX008 monotherapy There will be two cohorts in this study: Cohort 1 and Cohort 2. For Cohort 1, advanced gastric adenocarcinoma with failed first-line chemotherapy-line cancer participants, who had failed or were unable to tolerate first line chemotherapy with platinum-based or fluorouracil regimens. For Cohort 2, advanced solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.
详细描述
Cohort 1:
Currently, no PD-1 antibody against gastric cancer have been approved in China, and there are many patients with gastric cancer in China, so effective, low-toxicity and affordable treatment is urgently needed. This study aims to investigate the efficacy of combined application of recombinant human anti-PD-1 monoclonal antibody (HX008) and irinotecan in patients with locally advanced or metastatic gastric cancer (including gastric esophageal junction cancer) ,thus providing a better treatment for Chinese patients with gastric cancer.Advanced gastric adenocarcinoma with failed first-line chemotherapy-line cancer participants, who had failed or were unable to tolerate first line chemotherapy with platinum-based or fluorouracil regimens are needed.
Cohort 2:
Later-line therapies after failure of standard treatments for advanced solid cancer patients are limited. Mismatch repair (MMR) deficiency or microsatellite instability-high (MSI-H) played a role of positive predictive factor, which had been documented after the pembrolizumab and nivolumab trial were reported, for PD-1 blockade monotherapy in patients with advanced solid carcinomas.
In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) advanced solid tumors will be treated with HX008 monotherapy.Advanced solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy are needed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Anti-PD-1
Anti-PD-1 monoclonal antibody HX008 injection with a dose of 200mg (intravenous infusion, every 3 weeks)
干预措施: Anti-PD-1 monoclonal antibody (Drug)
结局指标
主要结局
ORR of HX008 combined with irinotecan and HX008 single drug
时间窗: Up to approximately 2 years
ORR was assessed according to Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1)
次要结局
- Duration of Response (DOR)(Up to approximately 2 years)
- Progression-Free Survival (PFS)(Up to approximately 2 years)
- HX008 safety and tolerability assessed by monitoring AEs(From screening to up to 1 months after the last dose of study drug (up to approximately 2 years))
- Immunogenicity(From the first dose of study drug (up to approximately 2 years))
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 2 years)