A Study of MRG002 in Treatment of Advanced HER-2 Positive Breast Cancer Patients

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)

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer With Liver Metastases
• Intervention / Treatment: Drug: MRG002

• Study Type: Interventional
• Enrollment (Anticipated): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100071
      • Recruiting
      • Fifth Medical Center of Pla General Hospital
      • Contact: Zefei Jiang, Doctor; Phone Number: 13901372170; Email: jiangzefei@csco.cog.cn
  • Guangdong
    • Guangzhou, Guangdong, China, 510300
      • Recruiting
      • Sun Yat-Sen Memorial Hospital
      • Contact: Qiang Liu, Doctor; Phone Number: 18922182851; Email: liuqiang_ng_sysu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willing to sign the informed consent form and follow the requirements specified in the protocol.
2. Aged 18 to 75 (including 18 and 75), both genders; Life expectancy ≥ 12 weeks;
3. The score of ECOG for performance status is 0 or 1
4. Patients with HER2-positive breast cancer confirmed by central laboratory and with evidence of liver metastasis by imaging;
5. Archival or biopsy tumor specimens should be provided (primary or metastatic) for HER2 testing;
6. Patients must have measurable lesions according to the Response Criteria in Solid Tumors (RECISTv1.1);
7. Organ functions must meet the basic requirements.
8. 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:

1. Previous history of other primary malignancies;
2. Presence of peripheral neuropathy ≥ grade 2 (according to CTCAE V5.0);
3. 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;
4. Central nervous system metastasis and/or neoplastic meningitis;
5. History of decompensated cirrhosis, or liver metastases with a single lesion ≥ 10 cm in longest diameter;
6. 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;
7. Any serious or uncontrolled systemic disease judged by the investigator;
8. Uncontrolled cardiac disease;
9. Evidence of active infection;
10. Pulmonary embolism or deep venous thrombosis within 3 months prior to study treatment;
11. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary dysfuction, symptomatic bronchospasm, etc.;
12. Patients with active autoimmune disease or a history of autoimmune diseases who are receiving immunosuppressive agents or systemic hormone therapy, and are still using them within 2 weeks prior to enrollment;
13. History of hypersensitivity to any component of MRG002 or known history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
14. Uncontrolled tumor-related bone pain or urgent spinal cord compression;
15. Other conditions inappropriate for participation in this study, as deemed by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRG002; MRG002 will be administrated via intravenous infusion of 2.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle).	Drug: MRG002; Administrated intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)	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)
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

Collaborators and Investigators

• Sponsor: Shanghai Miracogen Inc.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: HER2; MRG002; Antibody Drug Conjugate (ADC)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MRG002-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No