To assess the safety and tolerability of SHR-A1921 in patients with advanced solid tumours, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D) of SHR-A1921
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
Dose Limited Toxicity (DLT)
Time frame: 21 Days (first cycle)
Maximum Tolerable Dose (MTD)
Time frame: 21 Days (first cycle)
Recommended phase II dose (RP2D)
Time frame: Screening up to dose escalation and expansion study completion, appropriately to 1 year
Adverse Events
Incidence and grade of adverse events as assessed by CTCAE v5.0
Time frame: Screening up to study completion, an average of 1 year
Time to reach maximum concentration (Tmax) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Maximum concentration (Cmax) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Area under the concentration-time curve from time zero to the time of the last quantifiable time point t (AUC0-t) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-t) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Terminal half-life (t1/2) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
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Total body clearance (CL) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Volume of distribution at steady state (Vss) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Mean residence time (MRT) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Maximum steady-state drug concentration during a dosage interval (Css, max) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Minimum steady-state drug concentration during a dosage interval (Css, min) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Accumulation ratio (Rac) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Anti-drug antibody(ADA) level of SHR-A1921
Time frame: Screening up to 90 days after the last dose, an average of 1 year
Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Duration of Response (DoR) assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR) assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Progression-Free Survival (PFS) assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Overall Survival (OS)
Time frame: Screening up to study completion, an average of 1 year