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

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bolt Biotherapeutics, Inc.
• Collaborator: Bristol-Myers Squibb
• Treatments: Nivolumab; Pembrolizumab

Criteria

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 metastasis.

Other protocol defined inclusion/exclusion criteria may apply.