Study Stopped
Sponsor Decision
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors
1 other identifier
interventional
175
4 countries
21
Brief Summary
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2020
Longer than P75 for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedStudy Start
First participant enrolled
February 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2025
CompletedSeptember 15, 2025
September 1, 2025
4.8 years
February 12, 2020
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Escalation period
2 years
Incidence and nature of dose-limiting toxicities (DLTs)
Escalation period
up to 21 days
Incidence of potential-immune related toxicities
Escalation period
2 years
Maximum tolerable dose (MTD) or a tolerated dose below MTD
Escalation period
2 years
Objective response rate (ORR) of confirmed complete or partial responses (CR, PR)
Expansion period
2 years
Secondary Outcomes (14)
PK (Cmax) of BDC-1001
2 years
PK (Cmin) of BDC-1001
2 years
PK (AUC0-t) of BDC-1001
2 years
PK (AUC0-inf) of BDC-1001
2 years
PK (CL) of BDC-1001
2 years
- +9 more secondary outcomes
Study Arms (2)
Single agent BDC-1001
EXPERIMENTALEscalating doses followed by expansion targeting HER2-expressing advanced malignancies
Combination BDC-1001 plus nivolumab
EXPERIMENTALEscalating doses followed by expansion targeting HER2-expressing advanced malignancies
Interventions
Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
Programmed death receptor-1 (PD 1)-blocking antibody
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bolt Biotherapeutics, Inc.lead
- Bristol-Myers Squibbcollaborator
Study Sites (21)
Stanford University
Palo Alto, California, 94304, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Institut Bergonie
Bordeaux, 33076, France
Institut Paoli Calmettes
Marseille, 13009, France
Institut Gustave Roussy
Villejuif, 94805, France
Samsung Medical Center
Seoul, Gangnam-gu, 06351, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Asan Medical Center
Seoul, Songpa-gu, 05505, South Korea
Hospital del Mar
Barcelona, Catalonia, 08003, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bolt Clinical Development
Bolt Biotherapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 20, 2020
Study Start
February 24, 2020
Primary Completion
December 10, 2024
Study Completion
February 14, 2025
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share