A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.

A single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients. The ARX788 will be administered every 6 weeks (Q6W) intravenous (IV) infusion.

Inclusion Criteria:

• 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.

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.