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

Shanghai Miracogen

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer With Liver Metastases

Treatments: Drug: MRG002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05263869

MRG002-009

Details and patient eligibility

About

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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

MRG002

Experimental group

Description:

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

Treatment:

Drug: MRG002