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

Last updated: May 21, 2026
Sponsor: Eisai Inc.
Overall Status: Completed

Phase

2

Condition

Breast Cancer

Cancer

Treatment

BB-1701

Clinical Study ID

NCT06188559
BB-1701-G000-205
2023-506866-30
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of the Dose Optimization (Part 1) of this study is to assess the safety and tolerability of BB-1701 and to determine the recommended dose (RD) of BB-1701 for Dose Expansion (Part 2). The primary purpose of Dose Expansion (Part 2) is to assess the antitumor activity of BB-1701 at RD in the selected population(s) of breast cancer (BC).

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Male or female, aged >=18 years at the time of informed consent.

  • Metastatic or unresectable BC that is histologically confirmed to be either HER2-positive (defined as an immunohistochemistry [IHC] status of 3+, or a positive in situ hybridization [ISH] test [fluorescence, chromogenic, or silver-enhanced ISH] if IHC status is 2+) or HER2-low (defined as an IHC status of 1+, or 2+ and negative ISH) per the American Society of Clinical Oncology/College of American Pathology guidelines as documented prior to trastuzumab deruxtecan (T-DXd) treatment.

  • Must have previously received T-DXd.

  • Sufficient tumor tissue is required for HER2 status testing at a central laboratory.

  • Measurable disease per RECIST 1.1 as assessed by the investigator. Participants with bone only disease may be eligible if there is a measurable soft tissue component associated with the bone lesion.

  • Must have previously received at least 1 but no more than 3 prior chemotherapy-based regimes in the unresectable or metastatic setting. If recurrence occurred during or within 6 months of (neo) adjuvant chemotherapy, this would count as 1 line of chemotherapy.

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

  • ECOG PS 0 or 1.

  • Life expectancy of at least 3 months.

  • Adequate organ function and laboratory parameters.

Exclusion Criteria

  • Presence of brain or subdural metastases, unless participant has completed local therapy and has discontinued the use of corticosteroids for this indication for at least 2 weeks prior to starting treatment in this study.

  • Diagnosed with meningeal carcinomatosis.

  • Received anticancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, etc) or an investigational drug or device within the past 28 days or 5 half-lives, whichever is shorter.

  • Prior treatment with eribulin.

  • Any prior allergic reactions of Grade >=3 to monoclonal antibodies or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid).

  • Residual toxic effects of prior therapies or surgical procedures that is Grade >=2 (except alopecia or anemia).

  • Grade >=2 peripheral neuropathy or history of Grade >=3 peripheral neuropathy or discontinued any prior treatment due to peripheral neuropathy.

  • Active pneumonitis/interstitial lung disease (ILD) or any clinically significant lung disease (example, chronic obstructive pulmonary disease), history of Grade >=2 pneumonitis/ILD, or received radiotherapy to lung fields within 12 months of Cycle 1 Day 1 of study treatment.

  • Congestive heart failure greater than (>) New York Heart Association Class II or left ventricular ejection fraction (LVEF) less than (<) 50 percent (%) measured by multigated acquisition scan (MUGA) or echocardiogram.

  • Has a corrected QT interval prolongation per Fridericia formula (QTcF) >470 millisecond (ms) (for both males and females) based on screening triplicate 12-lead ECG.

  • Concomitant active infection requiring systemic treatment, except:

  • If known to be human immunodeficiency virus (HIV)-positive, must be on anti-HIV therapy for at least 4 weeks and have a clusters of differentiation 4+ T-cell (CD4+) count >=350 cells per microliter (cells/mcL) and an HIV viral load <400 copies per milliliter (copies/mL).

  • If meets the criteria for anti-hepatitis B virus (HBV) therapy, must agree to take anti-HBV therapy, if known to be HBV-positive as defined by positive hepatitis B surface antigen or hepatitis B core antibody. HBV viral load must be undetectable.

  • If known to be hepatitis C virus (HCV)-positive must have completed curative therapy for HCV. HCV viral load must be undetectable.

  • Known history of active bacillus tuberculosis (TB).

  • Any medical or other condition which, in the opinion of the investigator would preclude the participant's participation in the clinical study.

Study Design

Total Participants: 56
Treatment Group(s): 1
Primary Treatment: BB-1701
Phase: 2
Study Start date:
April 10, 2024
Estimated Completion Date:
March 18, 2026

Connect with a study center

  • CHU Besançon - Hôpital Jean Minjoz

    Besancon,
    France

    Site Not Available

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon,
    France

    Site Not Available

  • Institut Régional du Cancer de Montpellier

    Montpellier,
    France

    Site Not Available

  • Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO)

    Plerin,
    France

    Site Not Available

  • Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO)

    Plérin,
    France

    Site Not Available

  • Institut de Cancerologie de Ouest (ICO) - Saint-Herblain

    Saint-Herblain,
    France

    Site Not Available

  • Institut de Cancerologie de Ouest (ICO) - Saint-Herblain

    Saint-Herblain Cedex,
    France

    Site Not Available

  • Nagoya University Hospital

    Nagoya Shi, Aichi
    Japan

    Site Not Available

  • Nagoya University Hospital

    Nagoya, Aichi-ken
    Japan

    Site Not Available

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima
    Japan

    Site Not Available

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima-shi, Hiroshima-ken
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido
    Japan

    Site Not Available

  • Hyogo Medical University Hospital

    Nishinomiya-shi, Hyōgo
    Japan

    Site Not Available

  • Sagara Hospital, Social Medical Corporation Hakuaikai

    Kagoshima Shi, Kagoshima
    Japan

    Site Not Available

  • Sagara Hospital, Social Medical Corporation Hakuaikai

    Kagoshima, Kagoshima-ken
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Yokohama, Kanagawa
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Yokohama Shi, Kanagawa
    Japan

    Site Not Available

  • Kyoto University Hospital

    Sakyo-ku, Kyoto
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai, Miyagi
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai Shi, Miyagi
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama Shi, Okayama
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, Okayama-ken
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama
    Japan

    Site Not Available

  • Saitama Cancer Center

    Kitaadachi-gun, Saitama
    Japan

    Site Not Available

  • National Cancer Center Hospital (NCCH)

    Chuo-Ku, Tokyo
    Japan

    Site Not Available

  • St. Luke's International Hospital

    Chuou-ku, Tokyo
    Japan

    Site Not Available

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto Ku, Tokyo
    Japan

    Site Not Available

  • Showa Medical University

    Shinagawa Ku, Tokyo
    Japan

    Site Not Available

  • Showa University

    Shinagawa Ku, Tokyo
    Japan

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • HM Universitario Sanchinarro

    Madrid,
    Spain

    Site Not Available

  • Hospital Beata María Ana

    Madrid,
    Spain

    Site Not Available

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California 90720
    United States

    Site Not Available

  • UCLA Center for East-West Medicine

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCSF

    San Francisco, California 94143-2208
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • AdventHealth Cancer Institute - Orlando

    Orlando, Florida 32804
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612-9416
    United States

    Site Not Available

  • Fort Wayne Medical Oncology & Hematology

    Fort Wayne, Indiana 48604
    United States

    Site Not Available

  • Community Cancer Center South

    Indianapolis, Indiana 46227
    United States

    Site Not Available

  • Mission Blood and Cancer

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Mission Cancer and Blood

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • University of Michigan Hospital

    Ann Arbor, Michigan 48109-5000
    United States

    Site Not Available

  • Washington University in St. Louis School of Medicine

    Saint Louis, Missouri 63110-1032
    United States

    Site Not Available

  • Washington University in St. Louis School of Medicine

    St Louis, Missouri 63110-1032
    United States

    Site Not Available

  • NHO Revive Research Institute LLC

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Nebraska Cancer Specialist

    Omaha, Nebraska 68130-2042
    United States

    Site Not Available

  • Astera Cancer Care

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • Summit Medical Group

    Florham Park, New Jersey 07932-1049
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195-0001
    United States

    Site Not Available

  • Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)

    Cleveland, Ohio 44111
    United States

    Site Not Available

  • Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center

    Cleveland, Ohio 44124
    United States

    Site Not Available

  • Oregon Oncology Specialists

    Salem, Oregon 97301
    United States

    Site Not Available

  • UPMC CancerCenter at Magee - Womens Hospital

    Pittsburgh, Pennsylvania 15213-3108
    United States

    Site Not Available

  • St. Francis Cancer Center

    Greenville, South Carolina 29607-5253
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • The West Clinic, PLLC dba West Cancer Cente

    Germantown, Tennessee 38138-1762
    United States

    Site Not Available

  • Northwest Medical Specialties

    Puyallup, Washington 98373-1428
    United States

    Site Not Available

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