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A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Trial ID: NCT04278144
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors
Key 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
- 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
Other protocol defined inclusion/exclusion criteria may apply.