Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer

Exclusion Criteria

• •Any suspected or proven immunocompromised state, or infections, such as history of positive human immunodeficiency virus (HIV), known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV).
• •Any history or evidence of clinically significant cardiovascular disease.
• •Evidence of clinically significant cardiovascular and respiratory conditions
• •Previous antineoplastic treatment with immune checkpoint regulator or comparable immunotherapy within 8 weeks of starting study drug.
• •Chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2-directed therapies) within 4 weeks of starting study drug
• •Hormone therapy within 2 weeks of starting study medications.
• •Diagnosed with another malignancy that requires active therapy
• •Brain metastases that require directed therapy.
• •Has not recovered from any therapy related toxicities from previous treatments.
• •Use of any investigational drug within 4 weeks from the start of study drug.
• •Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results.