The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with with advanced pancreatic cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
SHR-A1904
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGDose-limiting toxicity (DLT) of SHR-A1904
Time frame: UP to 2 months
Maximum tolerated dose (MTD) of SHR-A1904
Time frame: UP to 2 months
Recommended Phase II Dose (RP2D)
Time frame: Up to 1 year
Maximum concentration (Cmax)
Time frame: Up to 1 year
Time to maximum concentration (Tmax)
Time frame: up to 1 year
Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)
Time frame: Up to 1 year
Anti-drug antibody (ADA) of SHR-A1904
Time frame: Up to 1 year
Objective response rate (ORR)
Time frame: Up to 1 year
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