Status:
TERMINATED
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Lead Sponsor:
Bolt Biotherapeutics, Inc.
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
HER2-positive Solid Tumors
HER2-positive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
Detailed Description
This study has four parts. Part 1 is a dose escalation of BDC-1001 as a single agent to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD) reco...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2025
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT04278144
Start Date
February 24 2020
End Date
February 14 2025
Last Update
September 15 2025
Active Locations (21)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
3
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215