Recombinant Human Anti-PD-1 Monoclonal Antibody HX008 Injection for the Treatment of Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Interventions
- Drug: Anti-PD-1 monoclonal antibody
- Registration Number
- NCT03704246
- Lead Sponsor
- Taizhou Hanzhong biomedical co. LTD
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 123
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anti-PD-1 Anti-PD-1 monoclonal antibody Anti-PD-1 monoclonal antibody HX008 injection with a dose of 200mg (intravenous infusion, every 3 weeks)
- Primary Outcome Measures
Name Time Method ORR of HX008 combined with irinotecan and HX008 single drug Up to approximately 2 years ORR was assessed according to Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1)
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to approximately 2 years per RECIST 1.1 assessed by central imaging vendor and investigator
Progression-Free Survival (PFS) Up to approximately 2 years per RECIST 1.1 assessed by central imaging vedor and investigator
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) Percentage of participants with adverse events (AEs), serious adverse events and AEs of special interest
Immunogenicity From the first dose of study drug (up to approximately 2 years) Measured by MSD electroluminescence detection method
Disease Control Rate (DCR) Up to approximately 2 years per RECIST 1.1 assessed by central imaging vendor and investigator
Overall Survival (OS) Up to approximately 2 years Calculated by the Kaplan-Meier method.
Trial Locations
- Locations (30)
Affiliated Hospital of Hebei University
🇨🇳Baoding, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Yuhe Combination of Chinese Traditional and Western Medicine Recovery Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, China
Hunan Cancer Hospital
🇨🇳Changsha, China
Xiangya Hospital, Central South University
🇨🇳Changsha, China
Heping Hospital Affiliated to Changzhi Medical College
🇨🇳Changzhi, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
The affiliated Cancer Hospital of Harbin Medical University
🇨🇳Harbin, China
Anhui Provincial Cancer Hospital
🇨🇳Hefei, China
Shandong Cancer Hospital
🇨🇳Jinan, China
Guangxi Medical University Cancer Hospital
🇨🇳Nanning, China
Fudan University Cancer Center
🇨🇳Shanghai, China
Peking university shenzhen hospital
🇨🇳Shenzhen, China
Liaoning Cancer Hospital
🇨🇳Shenyang, China
The First Hospital of China Medical University
🇨🇳Shenyang, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China
Tianjin People's Hospital
🇨🇳Tianjin, China
Hubei Cancer Hospital
🇨🇳Wuhan, China
Wuhan Central Hospital
🇨🇳Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian, China
The First Affiliated Hospital of Xinxiang Medical College
🇨🇳Xinxiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Jiangsu Provincial People's Hospital
🇨🇳Nanjing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China