This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
IBI939 injection
Sintilimab injection
Jilin Province Cancer Hospital
Jilin, China
Objective response rate(ORR)
Proportion of subjects with complete response(CR) or partial response(PR).
Time frame: 6 months
adverse event
Time frame: 3 months
Progression-free survival(PFS)
The time from randomization to the first occurrence of objective disease progression or death
Time frame: 6 months
Overall Survival(OS)
The time from randomization to death due to any cause.
Time frame: 6 months
Disease Control Rate(DCR)
Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).
Time frame: 6 months
Duration of Response (DoR)
The time from the first documented objective tumor response(CR or PR) to objective disease progression (PD) or death.
Time frame: 6 months
Time to Objective Response(TTR)
Time from randomization to first objective tumor response (CR or PR).
Time frame: 6 months
Area under the plasma concentration-time curve (AUC)
Time frame: 24 hours
Maximum concentration (Cmax)
Time frame: 24 hours
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Trough concentration (Cmin)
Time frame: 24 hours
Clearance (CL), 12. volume of distribution (V)
Time frame: 24 hours
Half-life (t1/2)
Time frame: 24 hours