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
Beijin, Beijing Municipality, China
RECRUITINGDose limiting toxicity (DLT)
Maximum tolerated dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of Anlotinib and TQB2450 in advanced acral malignant melanoma patients, Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21).
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