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TerminatedPhase 1 / Phase 2NCT04278144
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBDC-1001 and Nivolumab

The study team can explain what participation involves.

Who it may be forHER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 15, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?21 U.S. locations

Locations may change over time.

Who runs it?Bolt Biotherapeutics, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Bolt Biotherapeutics, Inc.
Interventions being studied
Drug: BDC-1001; Drug: Nivolumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
HER2→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Stanford UniversityPalo Alto, California
  • Georgetown University Medical CenterWashington D.C., District of Columbia
  • The University of Chicago Medical CenterChicago, Illinois
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • START MidwestGrand Rapids, Michigan
  • Memorial Sloan-Kettering Cancer CenterNew York, New York
  • Levine Cancer InstituteCharlotte, North Carolina
  • Stephenson Cancer CenterOklahoma City, Oklahoma
  • The University of Texas MD Anderson Cancer CenterHouston, Texas
  • South Texas Accelerated Research TherapeuticsSan Antonio, Texas
  • Virginia Cancer SpecialistsFairfax, Virginia
  • Institut BergonieBordeaux

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 15, 2025. Always confirm current availability with the study team.

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