A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

Inclusion Criteria

• Patient must have an advanced solid tumor with documented HER2-protein expression or gene amplification for which approved therapies have been exhausted or are not clinically indicated.
• Measurable disease as determined by RECIST v.1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Tumor tissue (archival or collected prior to the study start) available for exploratory biomarker evaluation. Key

Exclusion Criteria

• History of severe hypersensitivity to any ingredient of the study drug(s), including trastuzumab or other monoclonal antibody.
• Previous treatment with a TLR 7, TLR 8 or a TLR 7/8 agonist.
• Impaired cardiac function or history of clinically significant cardiac disease
• Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
• Active SARS-CoV-2 infection
• Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis. Other protocol defined inclusion/exclusion criteria may apply.