The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
SHR-A1811 subcutaneous injection.
SHR-A1811 for injection.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGArea under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc)
Time frame: About 72 weeks.
The incidence and severity of Dose-Limiting Toxicities (DLTs)
Time frame: About 72 weeks.
Adverse Events (AEs)
Time frame: About 72 weeks.
Time to maximum concentration (Tmax)
Time frame: About 72 weeks.
Maximum concentration (Cmax)
Time frame: About 72 weeks.
Trough concentration (Cmin)
Time frame: About 72 weeks.
Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)
Time frame: About 72 weeks.
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time frame: About 72 weeks.
Elimination half-life (t1/2)
Time frame: About 72 weeks.
Mean residence time (MRT)
Time frame: About 72 weeks.
Apparent clearance (CL/F)
Time frame: About 72 weeks.
Apparent volume of distribution at steady state (Vss/F)
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Time frame: About 72 weeks.
Area under the concentration-time curve at steady state (AUCss)
Time frame: About 72 weeks.
Maximum concentration at steady state (Css, max)
Time frame: About 72 weeks.
Trough concentration at steady state (Css, min)
Time frame: About 72 weeks.
Accumulation ratio (Rac)
Time frame: About 72 weeks.
Anti-SHR-A1811 antibodies (ADA)
Time frame: About 72 weeks.
Objective Response Rate (ORR)
Time frame: About 72 weeks.
Duration of Response (DoR)
Time frame: About 72 weeks.
Disease Control Rate (DCR)
Time frame: About 72 weeks.
Progression-Free Survival (PFS)
Time frame: About 72 weeks.
Overall Survival (OS)
Time frame: About 72 weeks.