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

This is an interventional treatment trial for HER2 Positive Metastatic Breast Cancer focused on measuring HER2-postive, Breast cancer, Antibody drug, Metastatic, ARX788, HER2 Read More

Inclusion Criteria:

• Age ≥ 18 years and older
• Life expectancy ≥ 6 months
• Eastern Cooperative Oncology Group Performance Status ≤ 1
• Her 2 Positive Metastatic breast cancer subjects previously treated with T-DXd
• Presence of at least one measurable lesion per RECIST v 1.1
• Subjects must have an adequate tumor sample available for confirmation of HER2 status
• Subjects with stable brain metastases
• Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1 as per the NCI-CTCAE v 5.0, except alopecia
• Adequate organ functions
• Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol
• Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or at postmenopausal, or who commits to use an acceptable form of birth control; male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control

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 active ocular infections
• History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia within 12 months prior to enrollment
• Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0). Patients with Grade 2 neuropathy can be enrolled at investigator's discretion
• History of unstable central nervous system (CNS) metastases
• 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
• Clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of ARX788
• Radiotherapy administered less than 21 days prior to the first dose of ARX788, or localized palliative radiotherapy administered less than 7 days prior to the first dose of ARX788, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 5.0
• Pregnancy or breast feeding
• Known active HCV, HBV, and/or HIV infection