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


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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

Official Title

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
   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

Other protocol defined inclusion/exclusion criteria may apply.


drug: BDC-1001

drug: Nivolumab


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Anastasia L Harper

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