ARX788 in HER2-positive Metastatic Breast Cancer Patients

Ki vehet részt

• 18 to 75 years old (including upper and lower limits), male or female
• Unresectable locally advanced, recurrent or metastatic BC
• Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC
• Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+)
• Has at least one measurable target lesion as per RECIST1.1 criteria
• Has recovered from any AE (≤ Grade 1) related to prior surgery and prior cancer treatment
• Adequate bone marrow, liver, kidney and coagulation function
• ECOG Performance Status Score of 0-1
• Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit

Ki nem vehet részt

• With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy
• Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines 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 known history to be allergic to any active ingredient or excipient of ARX788
• 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
• 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
• Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment
• 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