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Brief Title: 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
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
Study ID: NCT06188559
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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
Fort Wayne Medical Oncology & Hematology, Fort Wayne, Indiana, United States
Mission Blood and Cancer, Des Moines, Iowa, 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
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New Mexico Oncology Hematology Consultants, Albuquerque, New Mexico, United States
Oregon Oncology Specialists, Salem, Oregon, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Northwest Medical Specialties, Puyallup, Washington, United States
Nagoya University Hospital, Nagoya Shi, Aichi, Japan
Sagara Hospital, Social Medical Corporation Hakuaikai, Kagoshima Shi, Kagoshima, Japan
Kanagawa Cancer Center, Yokohama Shi, Kanagawa, Japan
Tohoku University Hospital, Sendai Shi, Miyagi, Japan
Okayama University Hospital, Okayama Shi, Okayama, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto Ku, Tokyo, Japan
Showa University, Shinagawa Ku, Tokyo, Japan