The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with EGFR-positive, HER2-negative, inoperable locally advanced or metastatic gastric cancer.
Approximately 6054 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Patients will receive 2.0 mg/kg dose of MRG003 intravenously every 3 weeks (Q3W) and may receive up to 24 months of MRG003 if there is evidence of clinical benefit to the patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Administered intravenously
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGHenan Tumor Hospital
Zhengzhou, Henan, China
RECRUITINGHubei Cancer Hospital
Wuhan, Hubei, China
RECRUITINGObjective Response Rate (ORR) by Independent Review Committee (IRC)
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.
Time frame: Baseline to study completion (up to 24 months)
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.
Time frame: Baseline to 30(for AE) and 45(for SAE) days after the last dose of study treatment
Objective Response Rate (ORR) by Investigator
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.
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)
Duration of Response (DoR)
DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
Time frame: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
DCR is defined as the proportions of patients achieving CR, PR, and stable disease (SD) after treatment.
Time frame: Baseline to study completion (up to 24 months)
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Jinan Central Hospital
Jinan, Shandong, China
RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
RECRUITINGOverall 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)
PK parameter for MRG003: (Cmax)
Maximum observed plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment
PK parameter for MRG003: (AUClast)
Area under the curve up to the last validated measurable plasma concentration
Time frame: Baseline to 30 days after the last dose of study treatment
PK parameter for total antibody (TAb): Cmax
Maximum observed plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment
PK parameter for TAb: AUClast
Area under the curve up to the last validated measurable plasma concentration
Time frame: Baseline to 30 days after the last dose of study treatment
PK parameter for Monomethyl Auristatin E (MMAE): Cmax
Maximum observed plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment
PK parameter for MMAE: AUClast
Area under the curve up to the last validated measurable plasma concentration
Time frame: Baseline to 30 days after the last dose of study treatment
The proportion of patients with positive of anti-drug antibody (ADA)
The proportion of patients with positive ADA immunogenicity results.
Time frame: Baseline to 30 days after the last dose of study treatment