A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer

Exclusion Criteria

• •Life expectancy \<3 months, as determined by the Investigator.
• •Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of BTX-A51
• •Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of BTX-A51
• •Major trauma or major surgery within 4 weeks prior to first dose of BTX-A51.
• •Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1 except for alopecia or Grade ≤2 immunotherapy-related thyroid toxicity.
• •History of, or known, central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
• •Clinically significant cardiac disease
• •Active uncontrolled systemic fungal, bacterial, mycobacterial, or viral infection
• •Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
• •Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
• •Second primary malignancy that has not been in remission for greater than 3 years
• •Any serious underlying medical (e.g., pulmonary, renal, hepatic, gastrointestinal, or neurological) or psychiatric condition (e.g., alcohol or drug abuse, dementia or altered mental status) or any issue that would limit compliance with study requirements
• •Pregnant, lactating, or breastfeeding.
• •Participation or plans to participate in another interventional clinical study.