A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors

Inclusion Criteria

• Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) or amplified solid tumor
• Subjects must have received prior therapies known to confer clinical benefit (unless ineligible or refused to receive)
• Measurable disease per RECIST 1.1
• Tumor lesion amenable for biopsy or able to provide tissue from biopsy within last 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematologic, hepatic, and cardiac function

Exclusion Criteria

• History of allergic reactions to certain components of SBT6050 or similar drugs
• Untreated brain metastases
• Active autoimmune disease or a documented history of autoimmune disease or syndrome
• Human immunodeficiency virus infection, active hepatitis B infection or hepatitis C infection
• Additional protocol defined inclusion/exclusion criteria may apply.