To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B208 in the trial participants of unresectable advanced or metastatic solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
539
ICP-B208 will be administered by intravenous infusion every 3 weeks (Q3W) until disease progression (PD) or the occurrence of unacceptable toxicity or withdrawal from the study for other reasons (whichever occurs first).
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The types, severity, correlation with the investigational drug and incidence of adverse events and serious adverse events
Time frame: 2 years
The types, severity and incidence of dose-limiting toxicity (DLT)
Time frame: 1 year
The Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD)
Time frame: 1 year
Objective response rate (ORR) by researchers
Time frame: 2 years
Maximum Plasma Concentration (Cmax)
Time frame: 1 year
Time to Maximum Plasma Concentration (Tmax)
Time frame: 1 year
Half-life (T1/2)
Time frame: 1 year
Area under the concentration-time curve from zero time to infinity (AUC0-∞)
Time frame: 1 year
Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t)
Time frame: 1 year
Apparent Clearance(CL/F)
Time frame: 1 year
Terminal Apparent Volume of Distribution (Vz/F)
Time frame: 1 year
The ORR evaluated by the researchers
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Time frame: 2 years
The Disease Control Rate (DCR) evaluated by the researchers
Time frame: 2 years
The Duration of Response (DOR) evaluated by the researchers
Time frame: 2 years
The Progression-Free Survival (PFS) evaluated by the researchers
Time frame: 2 years
The Radiographic Progression-Free Survival (rPFS) evaluated by the researchers
Time frame: 2 years
The Overall Survival (OS) evaluated by the researchers
Time frame: 2 years
Number of participants with anti-drug antibodies (ADA) to ICP-B208
Time frame: 1 year