A Phase Ib study aim to evaluate the efficacy, safety, and tolerability of IBI188 combination therapy in subjects with advanced malignancies
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Objective Response Rate
Time frame: 24 months
Adverse Events
Incidence, correlation with the study drug and severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
Time frame: 24 months
Progression-free survival
Time frame: 24 months
Overall survival
Time frame: 24 months
Disease control rate
Time frame: 24 months
Duration of response
Time frame: 24 months
Time to response
Time frame: 24 months
Area Under Curve, AUC
Time frame: 24 months
maximum concentration (Cmax)
Time frame: 24 months
minimum concentration (Cmin)
Time frame: 24 months
clearance (CL)
Time frame: 24 months
volume of distribution (V)
Time frame: 24 months
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intravenous
intravenous
intravenous
half-life (t1/2)
Time frame: 24 months
Positive rate of anti-drug antibody (ADA)
Time frame: 24 months
Positive rate of neutralizing antibody (NAb)
Time frame: 24 months