This is a randomized, double-blind, multi-center, phase III study to evaluate the efficacy and safety, pharmacokinetic profile and immunogenicity of MRG004A in patients with advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
MRG004A will be administrated as specified in the protocol.
Placebo will be administrated as specified in the protocol, following the same dose regimen as MRG004A.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Time frame: Baseline to study completion (up to 24 months)
Progression Free Survival (PFS)
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Time frame: Baseline to study completion (up to 24 months)
Objective Response Rate (ORR)
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.
Time frame: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Time frame: Baseline to study completion (up to 24 months)
Duration of Response (DOR)
The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.
Time frame: Baseline to study completion (up to 24 months)
Immunogenicity (ADA)
The proportion of patients with positive ADA results.
Time frame: Baseline to 14 days after the last dose.
Adverse Events (AEs)
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
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Time frame: Baseline to 30 days after the last dose of study treatment
Serious Adverse Events (SAEs)
Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions
Time frame: Baseline to 30 days after the last dose of study treatment