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Monoclonal Antibodies

Part 1, Dose Optimization, Cohort 1 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 35 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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 outcome measures

Part 1, Dose Optimization, AUC(0-inf): Area Under the Concentration-time Curve From Zero Time to Infinity of BB-1701, Total Antibody and Eribulin (Payload)

Part 1, Dose Optimization, AUC(0-t): Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration of BB-1701, Total Antibody and Eribulin (Payload)

Part 1, Dose Optimization, CL: Total Body Clearance of BB-1701

+23 more

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor

516 Previous Clinical Trials

158,901 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

Frequently Asked Questions

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

Are there any available openings for patients to participate in this study?

"According to the data available on clinicaltrials.gov, this particular study is currently not accepting new participants. The trial was first posted on December 27th, 2023 and last updated on December 20th, 2023. It's worth noting that despite this study being closed for recruitment, there are currently 2554 other active studies seeking eligible patients."

Answered by AI

Has the first cohort of Part 1, which focuses on dose optimization, received approval from the FDA?

"Based on our assessment, the safety of Part 1, Dose Optimization, Cohort 1 is rated as a 2. This rating reflects the available data supporting safety in this Phase 2 trial, but no evidence yet supporting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer

2024. "A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06188559.

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