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
42
a multi-target receptor tyrosine kinase inhibitor
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.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose limiting toxicity (DLT)
DLT defined as any of the following events occurring during the study related to drugs : (1) ≥grade 3 non-hematologic toxicity; (2) Grade 4 neutropenia, thrombocytopenia, and hemoglobin reduction confirmed by at least 2 tests within 2 days; Grade 3 thrombocytopenia with bleeding tendency confirmed by at least 2 tests within 2 days; (3) Grade 3 neutropenia with fever confirmed at least 2 times within 2 days.
Time frame: up to 21 days
Maximum tolerated dose (MTD)
MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT)
Time frame: up to 21 days
Recommended Phase II dose (RP2D)
The RP2D defined as the lower dose level to MTD based on the safety profile
Time frame: up to 24 months
Overall response rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR)
Time frame: up to 24 months
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
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 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
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Time frame: up to 24 months
Adverse Event
Number of participants with adverse events
Time frame: up to 24 months