A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
NCT ID: NCT04278144
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
175 participants
INTERVENTIONAL
2020-02-24
2025-02-14
Brief Summary
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Detailed Description
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Bolt amended the protocol to transition any subjects still receiving BDC-1001 to continue receiving BDC-1001 in the Maintenance Phase. Subjects remaining on BDC-1001 will continue to receive BDC-1001 until a criterion for discontinuation has been met.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single agent BDC-1001
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
BDC-1001
Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
Combination BDC-1001 plus nivolumab
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
BDC-1001
Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
Nivolumab
Programmed death receptor-1 (PD 1)-blocking antibody
Interventions
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BDC-1001
Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
Nivolumab
Programmed death receptor-1 (PD 1)-blocking antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Bolt Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bolt Clinical Development
Role: STUDY_DIRECTOR
Bolt Biotherapeutics
Locations
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Stanford University
Palo Alto, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Institut Bergonie
Bordeaux, , France
Institut Paoli Calmettes
Marseille, , France
Institut Gustave Roussy
Villejuif, , France
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Countries
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Other Identifiers
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BBI-20201001
Identifier Type: -
Identifier Source: org_study_id
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