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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.
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
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