A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors

Exclusion Criteria12

• Primary central nervous system disease or central nervous system metastatic disease.
• Prior exposure to a Claudin 18.2 targeting agent.
• Prior therapy with any chemotherapy, immunotherapy, anticancer agents, or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (eg, a period of 5 'half-lives'.
• Prior vaccination within 28 days of the first dose of study therapy.
• Prior any solid organ transplant. Autologous stem cell transplant or CAR-T cell infusion < 6 months prior to the first dose of study treatment.
• Active infection including hepatitis B, and/or hepatitis C.
• Known history of human immunodeficiency virus (HIV) infection.
• Any unresolved toxicities from prior therapy greater than Grade 1 at the time of ICF signature, with the exception of alopecia.
• Pregnant or nursing females.
• History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-022.
• Other primary malignancies developed within 5 years prior to the first dose of the study drug, except locally curable malignancies after radical treatment .
• In the opinion of the investigator, subject's complications, or other conditions (psychological, familial, sociological, or geographical etc.) may affect protocol compliance or may be unsuitable for participation in the study.