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HER2-positive Solid TumorsPhase 1/2NCT04278144

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

A Phase 1/2 study testing BDC-1001 and Nivolumab in people with HER2-positive Solid Tumors and HER2-positive Breast Cancer, run by Bolt Biotherapeutics, Inc. at 21 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
BDC-1001 and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
21 sitesin 4 countries
Study dates
24 Feb 2020to 14 Feb 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

21 sites in 4 countries.

21 sites in 4 countries

United States11 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • START Midwest

    Grand Rapids, Michigan, 49546

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Stanford University

    Palo Alto, California, 94304

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Spain4 sites

  • Hospital del Mar

    Barcelona, Catalonia, 08003

  • Hospital Universitario Vall d'Hebron

    Barcelona, Catalonia, 08035

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

Other trials in Spain

France3 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Institut Paoli Calmettes

    Marseille, 13009

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

South Korea3 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

  • Asan Medical Center

    Seoul, Songpa-gu, 05505

Other trials in South Korea

About this study

Official title: Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors

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

Read the 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) recommended for Part 3. In Part 3, the selected dose will be administered as monotherapy to patients with selected advanced malignancies. Part 2 is a dose escalation of BDC-1001 in combination with nivolumab to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD) recommended for Part 4. In Part 4, the selected dose will be administered in combination with nivolumab to patients with selected advanced malignancies.

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.

Being tested
BDC-1001, Nivolumab
Keywords
HER2, ERBB2, Immunotherapy, Gastric Cancer, Gastroesophageal junction, Breast Cancer, Stomach Cancer, Colorectal Cancer, Gastrointestinal Cancer, Non-Small Cell Lung Cancer, Biliary Tract Cancer, Head and Neck Cancer, Urothelial Cancer, Endometrial Cancer, TLR7/8 agonist
Medical subject headings
Stomach Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms, Carcinoma, Non-Small-Cell Lung, Biliary Tract Neoplasms, Head and Neck Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BDC-1001Drug

    Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

  • NivolumabDrug

    Also called Opdivo

    Programmed death receptor-1 (PD 1)-blocking antibody

Study groups in NCT04278144
Study groupRoleWhat they receive
Single agent BDC-1001ExperimentalEscalating doses followed by expansion targeting HER2-expressing advanced malignancies
Receives: Drug: BDC-1001
Combination BDC-1001 plus nivolumabExperimentalEscalating doses followed by expansion targeting HER2-expressing advanced malignancies
Receives: Drug: BDC-1001; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Escalation period

    Measured: 2 years

  2. Incidence and nature of dose-limiting toxicities (DLTs)

    Escalation period

    Measured: up to 21 days

  3. Incidence of potential-immune related toxicities

    Escalation period

    Measured: 2 years

  4. Maximum tolerable dose (MTD) or a tolerated dose below MTD

    Escalation period

    Measured: 2 years

  5. Objective response rate (ORR) of confirmed complete or partial responses (CR, PR)

    Expansion period

    Measured: 2 years

Secondary outcomes (14)

  1. PK (Cmax) of BDC-1001

    Escalation and expansion periods

    Measured: 2 years

  2. PK (Cmin) of BDC-1001

    Escalation and expansion periods

    Measured: 2 years

  3. PK (AUC0-t) of BDC-1001

    Escalation period

    Measured: 2 years

  4. PK (AUC0-inf) of BDC-1001

    Escalation period

    Measured: 2 years

  5. PK (CL) of BDC-1001

    Escalation period

    Measured: 2 years

  6. PK (Vz) of BDC-1001

    Escalation period

    Measured: 2 years

  7. PK (t1/2) of BDC-1001

    Escalation period

    Measured: 2 years

  8. Objective response rate (ORR) using RECIST 1.1

    Escalation period

    Measured: 2 years

  9. Duration of response (DOR)

    Escalation and expansion periods

    Measured: 2 years

  10. Disease control rate (DCR) of confirmed CR, PR, or stable disease (SD) lasting 4 or more weeks

    Escalation and expansion periods

    Measured: 2 years

  11. Progression Free Survival (PFS)

    Escalation and expansion periods

    Measured: 2 years

  12. Incidence of anti-BDC-1001 antibodies

    Escalation and expansion periods

    Measured: 2 years

  13. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Expansion period

    Measured: 2 years

  14. Incidence of potential-immune related toxicities

    Expansion period

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start24 Feb 2020
  3. Primary completion10 Dec 2024
  4. Study completion14 Feb 2025

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Multiple ascending dose and dose-expansion of BDC-1001 administered as a single agent or in combination with nivolumab.
Masking
None (open label)
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04278144
Sponsor's protocol ID
BBI-20201001
Status last verified
Sep 2025
First submitted
12 Feb 2020
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BDC-1001 and Nivolumab in people with HER2-positive Solid Tumors and HER2-positive Breast Cancer, run by Bolt Biotherapeutics, Inc. at 21 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Spain, France, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04278144.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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