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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRG002 | Experimental | MRG002 will be administrated via intravenous infusion of 2.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRG002 | Drug | Administrated intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective 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. | Baseline to study completion (up to 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to study completion (up to 12 months) |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Program Director | Contact | 86-21-61637960 | clinicaltrials@miracogen.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zefei Jiang, MD | Fifth Medical Center of PLA General Hospital | Principal Investigator |
| Qiang Liu, MD | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fifth Medical Center of PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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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.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline to 14 days after decision to discontinue treatment |
| Immunogenicity (ADA) | The proportion of patients with positive ADA results. | Baseline to 14 days after decision to discontinue treatment |
| Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | 510300 | China |
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