Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT05263869
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05263869
Study Brief:
Protocol Section:
NCT05263869