This study is an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events of drugs. Efficacy was evaluated using response evaluation criteria in solid tumors version (RECIST) 1.1 for immune-based therapeutics criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Humanized IgG4 mab targeting TIM-3
Monoclonal antibody against Programmed death factor receptor 1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose-limiting toxicity
Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose
Time frame: Initial administration up to 21 days
phase II recommended dose
Optimal tolerated dose determined after the end of phase 1
Time frame: At the end of phase I, 1 subject received the first dose up to 21 days
objective response rate
The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit (at the time of the next imaging evaluation)
Time frame: Baseline up to 96weeks
Progression-Free Survival
The time between the onset of first medication and disease progression (PD) or death before PD
Time frame: disease progression before death,no more than 100 months
Disease Control Rate
The ratio of disease control cases (Partial Remission+Complete Response+Partial Remission ) to total cases was calculated
Time frame: Baseline up to 96 weeks
Overall Survival
From the time of the patient's first treatment to the time of death from any cause
Time frame: No more than 100 months from the beginning of the first dose to death
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