An Open-label, Multi-center, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in Advanced HER-2 Positive Breast Cancer Patients Previously Treated With Trastuzumab and TKIs (Magic-009)

Shanghai Miracogen Inc.2 sites in 1 country99 target enrollmentMarch 23, 2022

ConditionsBreast Cancer With Liver Metastases

InterventionsMRG002

DrugsMRG002

Overview

Phase: Phase 2
Intervention: MRG002
Conditions: Breast Cancer With Liver Metastases
Sponsor: Shanghai Miracogen Inc.
Enrollment: 99
Locations: 2
Primary Endpoint: Objective Response Rate (ORR) by Independent Review Committee (IRC)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 23, 2022

End Date

October 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Miracogen Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing to sign the informed consent form and follow the requirements specified in the protocol.
•Aged 18 to 75 (including 18 and 75), both genders; Life expectancy ≥ 12 weeks;
•The score of ECOG for performance status is 0 or 1
•Patients with HER2-positive breast cancer confirmed by central laboratory and with evidence of liver metastasis by imaging;
•Archival or biopsy tumor specimens should be provided (primary or metastatic) for HER2 testing;
•Patients must have measurable lesions according to the Response Criteria in Solid Tumors (RECISTv1.1);
•Organ functions must meet the basic requirements.
•Patients of childbearing potential are willing to take effective contraceptive measures from the time of signing the informed consent form to 6 months after last administration of the study drug.

Exclusion Criteria

•Previous history of other primary malignancies;
•Presence of peripheral neuropathy ≥ grade 2 (according to CTCAE V5.0);
•Previously received antibody-drug conjugates, investigational drugs, anti-tumor vaccines or drugs, endocrine therapy for breast cancer, radiotherapy, CYP3A4 inhibitors or inducers, anthracyclines and other treatments;
•Central nervous system metastasis and/or neoplastic meningitis;
•History of decompensated cirrhosis, or liver metastases with a single lesion ≥ 10 cm in longest diameter;
•Pleural or peritoneal effusion with combined clinical symptoms, which seriously endangers the life safety of subjects or urgently requires clinical treatment; Or pericardial effusion with combined clinical symptoms;
•Any serious or uncontrolled systemic disease judged by the investigator;
•Uncontrolled cardiac disease;
•Evidence of active infection;
•Pulmonary embolism or deep venous thrombosis within 3 months prior to study treatment;

Arms & Interventions

MRG002

MRG002 will be administrated via intravenous infusion of 2.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle).

Intervention: MRG002

Outcomes

Primary Outcomes

Objective Response Rate (ORR) by Independent Review Committee (IRC)

Time Frame: Baseline to study completion (up to 12 months）

ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) assessed by IRC according to RECIST v1.1.

Secondary Outcomes

Duration of Response (DOR)(Baseline to study completion (up to 12 months))
Objective Response Rate (ORR) by Investigator(Baseline to study completion (up to 12 months))
Clinical Benefit Rate (CBR)(Baseline to study completion (up to 12 months))
Time to Response (TTR)(Baseline to study completion (up to 12 months))
Overall Survival (OS)(Baseline to study completion (up to 12 months))
PK parameters: concentration-time curve(Baseline to 14 days after decision to discontinue treatment)
Disease Control Rate (DCR)(Baseline to study completion (up to 12 months))
Progression Free Survival (PFS)(Baseline to study completion (up to 12 months))
Immunogenicity (ADA)(Baseline to 14 days after decision to discontinue treatment)
Adverse Events (AEs)(Baseline to 30 days after the last dose of study treatment)