The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in patients with HER2-positive /HER2-low locally advanced or metastatic gastric/ gastroesophageal junction cancer.
There are two cohorts in this study. HER2-positive and HER2-low patients will be allocated to cohort 1 and cohort 2, respectively. When the 20th, 40th, or 60th patient in each cohort completed at least one post-baseline tumor assessment, the Safety Monitoring Committee will review the safety and efficacy of these patients to determine dose selection, enrollment continuation, study population, and sample size.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Administrated intravenously
Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGShanghai Oriental Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGObjective Response Rate (ORR)
ORR is defined as the percentage of patients with a complete response (CR) and partial response (PR) 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 45 days after the lase dose of study treatment.
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.
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.
Duration of Response (DoR)
DOR is defined as the time from first documented objective 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 percentage of patients who achieve CR, PR, and stable disease (SD) after treatment.
Time frame: Baseline to study completion, up to 24 months.
Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve
Plot of drug concentration changing with time after drug administration.
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Time frame: Baseline to 30 days after the last dose of study treatment
Immunogenicity (ADA)
The proportion of patients with positive ADA results.
Time frame: Baseline to 30 days after the last dose of study treatment.