ARX788 in HER2-positive Metastatic Breast Cancer Patients

Exclusion Criteria

• •Has known history to be allergic to any active ingredient or excipient of ARX788;
• •With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy;
• •Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment;
• •Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
• •Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
• •Has cardiac insufficiency;
• •Uncontrolled hypertension;
• •Has evidence of severe or uncontrollable systemic diseases;
• •Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial;
• •Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial;
• •Is unwilling or unable to stop wearing corneal contact lens during the trial;
• •Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
• •Has any mental or cognitive disorder that may restrict his/her understanding and execution of the informed consent form;
• •Other conditions that the Investigator considers inappropriate for participation in this trial, such as poor compliance.