What side effects are associated with this type of intervention?

Common side effects of HER2-targeted therapies for breast cancer include decreased neutrophil count, anemia, nausea, fatigue, and diarrhea. Trastuzumab and pertuzumab can cause cardiac events such as a drop in left ventricular ejection fraction. Trastuzumab emtansine (T-DM1) may lead to fatigue and liver function abnormalities. Fam-trastuzumab deruxtecan (T-DXd) is associated with interstitial lung disease, which can be severe and potentially fatal. Monitoring for these side effects is crucial during treatment.

What prior FDA approvals exist?

The FDA has approved several HER2-targeted therapies for breast cancer. Trastuzumab (Herceptin) is a foundational treatment for HER2-positive breast cancer, often used in combination with chemotherapy. Pertuzumab (Perjeta) is approved for use with trastuzumab and docetaxel for metastatic HER2-positive breast cancer. Trastuzumab emtansine (Kadcyla) is an antibody-drug conjugate approved for patients who have previously received trastuzumab and chemotherapy. Neratinib (Nerlynx) in combination with capecitabine is approved for patients who have received two or more prior anti-HER2-based regimens. Lapatinib (Tykerb) combined with capecitabine is another option for patients progressing on trastuzumab. These therapies have shown significant improvements in progression-free survival and overall survival in clinical trials.

What other types of research exist?

Promising novel alternatives to BDC-1001 for HER2-positive breast cancer include Trastuzumab Deruxtecan (T-DXd), which has shown significant antitumor activity and safety in multiple studies, and Trastuzumab Emtansine (T-DM1), which has been effective in patients with brain metastases. Additionally, the tucatinib-trastuzumab-capecitabine regimen has demonstrated efficacy in treating leptomeningeal metastasis in HER2-positive breast cancer.

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Monoclonal Antibodies

BDC-1001 +/− Pertuzumab for Breast Cancer

Phase 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

Have received 2 or more prior lines of anti-HER2-directed therapies, at least 1 in the metastatic setting and including trastuzumab deruxtecan

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Previous treatment with a small molecule TLR7/8 agonist or TLR7/8 agonist that has been conjugated to tumor-targeting antibody such as ISACs within 12 months before starting study treatment

Impaired cardiac function or history of clinically significant cardiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, BDC-1001, alone or with pertuzumab, in patients with HER2-positive metastatic breast cancer who didn't respond to previous treatments. The treatment targets and attacks cancer cells by recognizing a specific marker on them. Pertuzumab is an approved treatment for HER2-positive metastatic breast cancer.

Who is the study for?

This trial is for individuals with HER2-positive metastatic breast cancer who have tried at least two anti-HER2 therapies, including trastuzumab deruxtecan. Participants should be in good physical condition (ECOG 0 or 1), have measurable disease, and a life expectancy over 12 weeks. They must agree to a biopsy or provide an archival tissue sample if needed.

What is being tested?

The study is testing BDC-1001 alone and combined with pertuzumab to assess their effectiveness, safety, tolerability, how the body processes them (PK/PD), and immune response in patients previously treated with trastuzumab deruxtecan for HER2+ metastatic breast cancer.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's activation by BDC-1001 or infusion-related reactions from pertuzumab. Other common drug-related side effects could involve fatigue, nausea, skin reactions, or changes in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had at least 2 treatments targeting HER2, including trastuzumab deruxtecan.

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

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My breast cancer is confirmed to be HER2 positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had TLR7/8 agonist treatment or ISACs in the last year.

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I have a history of heart problems or current heart issues.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Anti-tumor activity of BDC-1001 as a single agent and in combination with pertuzumab

Exposure profile of BDC-1001 as a single agent and in combination with pertuzumab

Immunogenicity of BDC-1001 as a single agent and in combination with pertuzumab

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: BDC-1001 in Combination With PertuzumabExperimental Treatment2 Interventions

BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.

Group II: BDC-1001 Single AgentExperimental Treatment1 Intervention

BDC-1001 administered intravenously (IV) every 2 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pertuzumab

2014

Completed Phase 3

~7500

0 / 6Eligibility 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

HER2-targeted therapies, such as trastuzumab, pertuzumab, and trastuzumab emtansine, are crucial in the treatment of HER2-positive breast cancer. Trastuzumab is a monoclonal antibody that binds to the HER2 receptor on cancer cells, inhibiting their growth and survival. Pertuzumab also targets the HER2 receptor but binds to a different site, preventing the receptor from pairing with other HER receptors, which enhances the anti-tumor effect when used in combination with trastuzumab. Trastuzumab emtansine combines trastuzumab with a chemotherapy drug, delivering the cytotoxic agent directly to the cancer cells, thereby reducing systemic side effects. These therapies are significant for patients as they specifically target cancer cells, improving treatment efficacy and potentially reducing adverse effects compared to traditional chemotherapy.

Overcoming trastuzumab resistance in HER2-positive breast cancer using combination therapy.