A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Reason given: Sponsor Decision
Key facts
- Where
- Boston, Charlotte, Chicago, Fairfax, Grand Rapids, Houston, New York, Oklahoma City, Palo Alto, San Antonio, and Washington D.C., United StatesSee the 11 sites
- Phase
- Phase 1/2
Where in United States
- Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
- Levine Cancer InstituteCharlotte, United StatesNo longer taking part
- The University of Chicago Medical CenterChicago, United StatesNo longer taking part
- Virginia Cancer SpecialistsFairfax, United StatesNo longer taking part
- START | MidwestGrand Rapids, United StatesNo longer taking part
- The University of Texas MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- Stephenson Cancer CenterOklahoma City, United StatesNo longer taking part
- Stanford UniversityPalo Alto, United StatesNo longer taking part
- South Texas Accelerated Research TherapeuticsSan Antonio, United StatesNo longer taking part
- Georgetown University Medical CenterWashington D.C., United StatesNo longer taking part
Trial details
- Who runs it
- Bolt Biotherapeutics, Inc.
- Trial code
- NCT04278144
- Record updated
- 15 September 2025
- Original description
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignanciesRead full original descriptionShow less
Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
Inclusion: 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.
Exclusion: Previous treatment with a TLR 7, TLR 8 or a TLR 7/8 agonist; History of severe hypersensitivity to any ingredient of the study drug(s), including trastuzumab or other monoclonal antibody; 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.