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 or NCT#

NCT04278144

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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.
    1. Key
Exclusion Criteria:
  1. * 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.
    1. Other protocol defined inclusion/exclusion criteria may apply.
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Contact us to find out if this trial is right for you.

Contact

Anastasia L Harper
650-725-0378

View on ClinicalTrials.gov