TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Peking University First Hospital
Beijing, Beijing Municipality, China
Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Objective Response Rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Time frame: up to 96 weeks
Progression-Free Survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 96 weeks
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time frame: up to 96 weeks
Disease Control Rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 24 months
Time to Response (TTR)
TTR defined as time from the first dose to the first assessment of PR or CR.
Time frame: up to 24 months
Overall Survival (OS)
OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 24 months
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijin, Beijing Municipality, China
Peking Hospital
Beijin, Beijing Municipality, China
Union Medical College Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan People's Hospital
Zhengzhou, Henan, China
...and 8 more locations