ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)

Exclusion Criteria

• •Any subject who meets any of the following criteria is excluded from the study:
• •History of allergic reactions to any component of ARX788.
• •Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease. Any requirement for supplemental oxygen.
• •Any active ocular infections or chronic corneal disorders
• •History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment
• •Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0).
• •History of unstable central nervous system (CNS) metastases
• •Radiotherapy outside of the brain administered \< 7 days prior to first dose of ARX788
• •Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic diseases)
• •Any uncontrollable intercurrent illness, infection (including subjects with active, symptomatic Covid-19 infections), or other conditions that could limit study compliance or interfere with assessments
• •Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788