The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2 positive breast cancer with liver metastases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Administrated intravenously
Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
RECRUITINGObjective Response Rate (ORR) by Independent Review Committee (IRC)
ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) assessed by IRC according to RECIST v1.1.
Time frame: Baseline to study completion (up to 12 months)
Objective Response Rate (ORR) by Investigator
ORR is defined as the proportion of subjects with CR and PR assessed by investigator according to RECIST v1.1.
Time frame: Baseline to study completion (up to 12 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 12 months)
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of subjects with CR, PR and stable disease (SD) ≥ 6 months after treatment.
Time frame: Baseline to study completion (up to 12 months)
Time to Response (TTR)
TTR is defined as the time from the start of treatment until the first occurrence of CR or PR by tumor assessment.
Time frame: Baseline to study completion (up to 12 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 12 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.
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Time frame: Baseline to study completion (up to 12 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 12 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 days after the last dose of study treatment
PK parameters: concentration-time curve
Plot of drug concentration changing with time after drug administration.
Time frame: Baseline to 14 days after decision to discontinue treatment
Immunogenicity (ADA)
The proportion of patients with positive ADA results.
Time frame: Baseline to 14 days after decision to discontinue treatment