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Monoclonal Antibodies

BDC-1001 + Nivolumab for Breast Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Bolt Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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
Must not have
Active SARS-CoV-2 infection
Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights


This trial is testing a new drug, BDC-1001, as a possible treatment for HER2-positive cancer. The drug will be tested alone and in combination with another drug, nivolumab.

Who is the study for?
This trial is for adults with advanced solid tumors expressing HER2, such as certain breast, colorectal, gastroesophageal, and endometrial cancers. Participants must have tried all other approved treatments without success. They should be relatively healthy (ECOG status 0 or 1) and able to provide tumor tissue for research.Check my eligibility
What is being tested?
The study is testing BDC-1001 alone and combined with Nivolumab in patients whose tumors overexpress the HER2 protein or gene. It's a first-in-human trial aiming to find out how safe these treatments are and how well they work against different types of cancer.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to ingredients similar to trastuzumab, immune-related issues from Nivolumab like inflammation in organs or skin problems, fatigue, infusion reactions, and possibly others not yet known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am fully active or restricted in physically strenuous activity but can do light work.
My advanced cancer shows HER2 protein or gene changes and no standard treatments are suitable for me.
My advanced cancer shows HER2 activity and I've tried all other approved treatments.
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I currently have COVID-19.
I have not received treatment for tumors or cancer spread to my brain or spinal cord.
I have HIV, active hepatitis B, or hepatitis C.
I have a history of heart problems.
I have been treated with a TLR 7, TLR 8, or TLR 7/8 agonist before.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and nature of dose-limiting toxicities (DLTs)
Maximum tolerable dose (MTD) or a tolerated dose below MTD
Objective response rate (ORR) of confirmed complete or partial responses (CR, PR)
Secondary outcome measures
Disease control rate (DCR) of confirmed CR, PR, or stable disease (SD) lasting 4 or more weeks
Duration of response (DOR)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single agent BDC-1001Experimental Treatment1 Intervention
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
Group II: Combination BDC-1001 plus nivolumabExperimental Treatment2 Interventions
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer include HER2-targeted therapies and immune checkpoint inhibitors. HER2-targeted therapies, such as trastuzumab, bind to the HER2 receptor on cancer cells, inhibiting their growth and survival. Immune checkpoint inhibitors like Nivolumab block the PD-1 pathway, which cancer cells use to evade the immune system, thereby enhancing the immune response against cancer cells. These mechanisms are crucial for breast cancer patients as they offer a dual approach: directly targeting cancer cell proliferation and boosting the body's immune response to fight cancer more effectively.
Management of Brain and Leptomeningeal Metastases from Breast Cancer.Pharmacokinetic and pharmacodynamic evaluation of panitumumab in the treatment of colorectal cancer.New drugs for breast cancer.

Find a Location

Who is running the clinical trial?

Bolt Biotherapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
233 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,359 Total Patients Enrolled
51 Trials studying Breast Cancer
8,265 Patients Enrolled for Breast Cancer
Bolt Clinical DevelopmentStudy DirectorBolt Biotherapeutics
2 Previous Clinical Trials
233 Total Patients Enrolled

Media Library

BDC-1001 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04278144 — Phase 1 & 2
Breast Cancer Research Study Groups: Single agent BDC-1001, Combination BDC-1001 plus nivolumab
Breast Cancer Clinical Trial 2023: BDC-1001 Highlights & Side Effects. Trial Name: NCT04278144 — Phase 1 & 2
BDC-1001 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278144 — Phase 1 & 2
~40 spots leftby Jan 2025