Recombinant Human Anti-PD-1 Monoclonal Antibody HX008 Injection for the Treatment of Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03704246|
Recruitment Status : Active, not recruiting
First Posted : October 12, 2018
Last Update Posted : March 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: Anti-PD-1 monoclonal antibody||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||123 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open and Phase II Clinical Study of HX008 for the Treatment in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||September 30, 2018|
|Actual Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||March 30, 2021|
Anti-PD-1 monoclonal antibody HX008 injection with a dose of 200mg (intravenous infusion, every 3 weeks)
Drug: Anti-PD-1 monoclonal antibody
HX008 is a monoclonal antibody drug which is intravenous drip at a dose of 200mg.
Other Name: HX008
- ORR of HX008 combined with irinotecan and HX008 single drug [ Time Frame: Up to approximately 2 years ]ORR was assessed according to Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1)
- HX008 safety and tolerability assessed by monitoring AEs [ Time Frame: 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
- Disease Control Rate (DCR) [ Time Frame: Up to approximately 2 years ]per RECIST 1.1 assessed by central imaging vendor and investigator
- Duration of Response (DOR) [ Time Frame: Up to approximately 2 years ]per RECIST 1.1 assessed by central imaging vendor and investigator
- Progression-Free Survival (PFS) [ Time Frame: Up to approximately 2 years ]per RECIST 1.1 assessed by central imaging vedor and investigator
- Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]Calculated by the Kaplan-Meier method.
- Immunogenicity [ Time Frame: From the first dose of study drug (up to approximately 2 years) ]Measured by MSD electroluminescence detection method
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704246