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Monoclonal Antibodies

BB-1701 for Breast Cancer

Phase 2

Recruiting

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If HR-positive HER2-low BC, must have previously received endocrine therapy and is not expected to benefit from further endocrine therapy

Metastatic or unresectable BC that is histologically confirmed to be either HER2-positive or HER2-low per the American Society of Clinical Oncology/College of American Pathology guidelines as documented at the time of trastuzumab deruxtecan (T-DXd) treatment

Must not have

Presence of malignant effusion/ascites requiring drainage for symptom relief

Any prior hypersensitivity to monoclonal antibodies or contraindication to the receipt of corticosteroids or any of the excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 35 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is divided into two parts. In the first part, we will test the safety of a drug called BB-1701 and determine the correct dose to use. In the second part, we

Who is the study for?

This trial is for individuals who have been previously treated for breast cancer that tests positive or low for HER2 and cannot be surgically removed or has spread. Specific eligibility details are not provided, but typically include health status and prior treatments.

What is being tested?

The study is testing BB-1701's safety, tolerability, and optimal dosing in part one. In part two, it will evaluate the effectiveness of BB-1701 at the recommended dose in selected breast cancer populations.

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at the injection site, nausea, fatigue, blood count changes, and potential allergic responses to medication.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is HR-positive, HER2-low, and endocrine therapy is no longer effective for me.

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My breast cancer is advanced, cannot be surgically removed, and is HER2-positive or HER2-low.

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

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I have previously been treated with T-DXd.

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My tumor sample is enough for HER2 testing at a specialized lab.

Exclusion Criteria

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

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I need drainage for relief from fluid buildup due to cancer.

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I am not allergic to monoclonal antibodies or corticosteroids.

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I have severe nerve pain or had to stop treatment because of it.

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I do not have active lung disease or a history of lung disease that needed steroids.

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I have an active TB infection.

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I have inflammatory breast cancer.

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I have been diagnosed with cancer in the lining of my brain and spinal cord.

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I haven't taken any cancer treatment or experimental drugs in the last 28 days.

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I have been treated with eribulin before.

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I have no lasting side effects from past treatments or surgeries, except for hair loss or low blood count.

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My heart's pumping ability is below normal or I have moderate heart failure.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 35 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 35 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 35 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1, Dose Optimization: Number of Participants With Adverse Events (AEs)

Part 1, Dose Optimization: Number of Participants With Clinically Significant 12-lead ECGs Values

Part 1, Dose Optimization: Number of Participants With Clinically Significant Laboratory Values

+4 more

Secondary study objectives

Part 1, Dose Optimization: Clinical Benefit Rate (CBR)

Part 1, Dose Optimization: Disease Control Rate (DCR)

Part 1, Dose Optimization: Duration of Response (DOR)

+14 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2, Dose ExpansionExperimental Treatment1 Intervention

HER2-positive or HER2-low, unresectable or metastatic BC.

Group II: Part 1, Dose Optimization, Cohort 3Experimental Treatment1 Intervention

HER2-positive or HER2-low, unresectable or metastatic BC.

Group III: Part 1, Dose Optimization, Cohort 2Experimental Treatment1 Intervention

HER2-positive or HER2-low, unresectable or metastatic BC.

Group IV: Part 1, Dose Optimization, Cohort 1Experimental Treatment1 Intervention

HER2-positive or HER2-low, unresectable or metastatic BC.

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor

521 Previous Clinical Trials

159,730 Total Patients Enrolled

16 Trials studying Breast Cancer

1,909 Patients Enrolled for Breast Cancer

Bliss Biopharmaceutical (Hangzhou) Co., LtdIndustry Sponsor

3 Previous Clinical Trials

796 Total Patients Enrolled

~90 spots leftby Oct 2026

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