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Experimental cancer combo trial halted early – what it means for patients

NCT ID NCT04278144

Disease control Sponsor: Bolt Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-stage trial tested a new drug called BDC-1001, alone or with the immunotherapy nivolumab, in 175 people with advanced HER2-positive cancers (like breast, colorectal, and stomach cancers) that had stopped responding to other treatments. The study aimed to check safety and find the right dose, but it was terminated early, so full results are not available. The approach tries to stimulate the immune system to attack cancer cells, but it is still experimental.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BDC-1001 (an immune-stimulating antibody conjugate) and nivolumab (Opdivo, an immunotherapy)
What this could lead to
If successful, this could point toward a new treatment option for advanced HER2-positive cancers that have stopped responding to standard therapies.
What could go wrong
This was a very early (Phase 1/2) trial that was terminated, so results are limited. The combination may cause significant immune-related side effects, and it is unclear if it will work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

175 people

The number who actually took part.

Started

Feb 2020

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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 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/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Biliary Tract Neoplasms breast neoplasm colorectal cancer colorectal carcinoma colorectal neoplasm digestive system neoplasm endometrial carcinoma endometrium neoplasm gastric neoplasm gastroesophageal cancer Head and Neck Neoplasms HER2 positive breast carcinoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2-positive breast cancer HER2-positive colorectal cancer HER2-positive endometrial cancer HER2-positive gastroesophageal cancer HER2-positive solid tumors

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, Songpa-gu, 05505, South Korea

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital del Mar

    Barcelona, Catalonia, 08003, Spain

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.