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

NCT ID: NCT06188559

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2026-03-31

Brief 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).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1, Dose Optimization, Cohort 1

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

Group Type: EXPERIMENTAL

BB-1701

Intervention Type: DRUG

BB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle).

Part 1, Dose Optimization, Cohort 2

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

Group Type: EXPERIMENTAL

BB-1701

Intervention Type: DRUG

BB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle).

Part 1, Dose Optimization, Cohort 3

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

Group Type: EXPERIMENTAL

BB-1701

Intervention Type: DRUG

BB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle).

Part 2, Dose Expansion

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

Group Type: EXPERIMENTAL

BB-1701

Intervention Type: DRUG

BB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle).

Interventions

BB-1701

BB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bliss Biopharmaceutical (Hangzhou) Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

UCLA Center for East-West Medicine

Los Angeles, California, United States

UCSF

San Francisco, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

AdventHealth Cancer Institute - Orlando

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Fort Wayne Medical Oncology & Hematology

Fort Wayne, Indiana, United States

Community Cancer Center South

Indianapolis, Indiana, United States

Mission Blood and Cancer

Des Moines, Iowa, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Washington University in St. Louis School of Medicine

St Louis, Missouri, United States

NHO Revive Research Institute LLC

Lincoln, Nebraska, United States

Nebraska Cancer Specialist

Omaha, Nebraska, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Summit Medical Group

Florham Park, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

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

Cleveland, Ohio, United States

Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Oncology Specialists

Salem, Oregon, United States

UPMC CancerCenter at Magee - Womens Hospital

Pittsburgh, Pennsylvania, United States

St. Francis Cancer Center

Greenville, South Carolina, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

The West Clinic, PLLC dba West Cancer Cente

Germantown, Tennessee, United States

Northwest Medical Specialties

Puyallup, Washington, United States

CHU Besançon - Hôpital Jean Minjoz

Besançon, , France

Institut Régional du Cancer de Montpellier

Montpellier, , France

Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO)

Plérin, , France

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

Saint-Herblain, , France

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Hiroshima, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Hyogo Medical University Hospital

Nishinomiya-shi, Hyōgo, Japan

Sagara Hospital, Social Medical Corporation Hakuaikai

Kagoshima, Kagoshima-ken, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

National Cancer Center Hospital (NCCH)

Chūōku, Kansai, Japan

Kyoto University Hospital

Sakyo-ku, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, Japan

Saitama Cancer Center

Kitaadachi-gun, Saitama, Japan

St. Luke's International Hospital

Chuou-ku, Tokyo, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto Ku, Tokyo, Japan

Showa University

Shinagawa Ku, Tokyo, Japan

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

HM Universitario Sanchinarro

Madrid, , Spain

Hospital Beata María Ana

Madrid, , Spain

Countries

United States; France; Japan; Spain

Other Identifiers

2023-506866-30

Identifier Type: OTHER

Identifier Source: secondary_id

BB-1701-G000-205

Identifier Type: -

Identifier Source: org_study_id