First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors

Exclusion Criteria

• •Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration
• •Prior treatment with an ADC containing a topoisomerase I inhibitor payload
• •Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required
• •Other malignancy
• •Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration
• •Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment
• •Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1
• •Clinically significant cardiovascular disease
• •Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2
• •Current active liver disease due to hepatitis B or hepatitis C
• •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis