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Monoclonal Antibodies

BDC-1001 +/− Pertuzumab for Breast Cancer

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial evaluates a new drug to treat HER2+ metastatic breast cancer with a combination of two drugs.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bolt Biotherapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

557 Total Patients Enrolled

Hoffmann-La RocheIndustry Sponsor

2,432 Previous Clinical Trials

1,090,095 Total Patients Enrolled

160 Trials studying Breast Cancer

91,442 Patients Enrolled for Breast Cancer

Bolt Clinical DevelopmentStudy DirectorBolt Biotherapeutics

2 Previous Clinical Trials

557 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is BDC-1001 Single Agent a risk-free treatment for individuals?

"BDC-1001 Single Agent has been evaluated as 2 on a scale of 1 to 3. This is because there are safety data available, but no efficacy evidence for the drug at this stage in development."

Answered by AI

How many test subjects have joined this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this clinical trial is still recruiting patients as of today. After its initial post date on October 1st 2023 and latest update on September 19th 2023, the study seeks 66 participants from a single site."

Answered by AI

Is enrollment open for this trial at present?

"Affirmative. According to information listed on clinicaltrials.gov, the trial is still open for recruitment and was initially posted on October 1st 2023. It has since been updated as recently as September 19th 2023 with a goal of recruiting 66 participants from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

2023. "Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05954143.