What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those targeting HER2 and involving PD-1 inhibitors, have a range of side effects. HER2-targeted therapies such as trastuzumab and lapatinib often cause diarrhea, rash, erythema, and hepatic issues, with trastuzumab also posing a risk of cardiac dysfunction. PD-1 inhibitors like Nivolumab can lead to immune-related adverse events including fatigue, rash, diarrhea, pneumonitis, and thyroid dysfunction. These side effects are important considerations for patients undergoing these treatments.

What prior FDA approvals exist?

FDA-approved treatments for HER2-positive breast cancer include Trastuzumab (Herceptin), Pertuzumab (Perjeta), and Ado-trastuzumab emtansine (Kadcyla), which target the HER2 receptor. Additionally, immune checkpoint inhibitors like Pembrolizumab (Keytruda) have been approved for breast cancers with high PD-L1 expression. The combination of HER2-targeted therapies and immune checkpoint inhibitors, as studied in the trial with BDC-1001 and Nivolumab, represents a promising approach to improve treatment outcomes.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Trastuzumab Deruxtecan (Enhertu), an antibody-drug conjugate targeting HER2, showing efficacy in HER2-positive breast cancer. 2) Margetuximab, a HER2-targeted monoclonal antibody with enhanced immune activation. 3) Pembrolizumab (Keytruda), another PD-1 inhibitor, which has shown promise in combination with chemotherapy for triple-negative breast cancer. 4) Sacituzumab Govitecan (Trodelvy), an antibody-drug conjugate targeting Trop-2, effective in triple-negative breast cancer. 5) Tucatinib, a HER2-targeted tyrosine kinase inhibitor, used in combination with trastuzumab and capecitabine for HER2-positive metastatic breast cancer.

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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Summary

This trial tests a new drug, BDC-1001, alone and with another drug, in patients with advanced HER2-positive cancers. BDC-1001 aims to attack cancer cells directly, and the other drug boosts the immune system to fight the cancer.

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.

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.

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My advanced cancer shows HER2 protein or gene changes and no standard treatments are suitable for me.

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My advanced cancer shows HER2 activity and I've tried all other approved treatments.

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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:

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I currently have COVID-19.

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I have not received treatment for tumors or cancer spread to my brain or spinal cord.

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I have HIV, active hepatitis B, or hepatitis C.

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I have a history of heart problems.

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I have been treated with a TLR 7, TLR 8, or TLR 7/8 agonist before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

0 / 9Eligibility criteria met

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.