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

NCT ID: NCT05263869

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2023-10-31

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.

Conditions

Breast Cancer With Liver Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRG002

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

Group Type: EXPERIMENTAL

MRG002

Intervention Type: DRUG

Administrated intravenously

Interventions

MRG002

Administrated intravenously

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Miracogen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zefei Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Fifth Medical Center of PLA General Hospital

Qiang Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Program Director

Role: CONTACT

clinicaltrials@miracogen.com.cn

86-21-61637960

Facility Contacts

Zefei Jiang, Doctor

Role: primary

jiangzefei@csco.cog.cn

13901372170

Qiang Liu, Doctor

Role: primary

liuqiang_ng_sysu@163.com

18922182851

Other Identifiers

MRG002-009

Identifier Type: -

Identifier Source: org_study_id