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ACTIVE NOT RECRUITING
NCT06188559
PHASE2

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

Sponsor: Eisai Inc.

View on ClinicalTrials.gov

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).

Official title: An Open-label, Multicenter, Phase 2 Dose Optimization and Expansion Study to Evaluate the Safety and Efficacy of BB-1701, an Anti-human Epidermal Growth Factor Receptor 2 (Anti-HER2) Antibody-drug Conjugate (ADC), in Previously Treated Subjects With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2024-04-10

Completion Date

2027-03-31

Last Updated

2026-03-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

BB-1701

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

Locations (49)

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

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

National Cancer Center Hospital (NCCH)

Chuo-Ku, Tokyo, 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 Medical University

Shinagawa Ku, Tokyo, Japan

Hospital Universitario Vall d'Hebron

Barcelona, Spain

HM Universitario Sanchinarro

Madrid, Spain

Hospital Beata María Ana

Madrid, Spain