To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
SHR-A1912, dose escalation and expansion.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Adverse Events
Time frame: 21 Days after the 1st dosing (first cycle)
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: Up to approximately 2 years
Adverse Events
Time frame: 12 weeks after the last dose
Time of maximum observed plasma concentration (Tmax) of SHR-1912
Time frame: 21 days after last dose
Maximum observed plasma concentration (Cmax) of SHR-1912
Time frame: 21 days after last dose
Area under the plasma concentration time curve (AUC) of SHR-1912
Time frame: 21 days after last dose
Anti-drug antibody (ADA) of SHR-A1912
Time frame: 12 weeks after last dose
Complete Response Rate (CR)
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Duration of Response (DoR)
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Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 3 years