82
Participants
Start Date
September 30, 2019
Primary Completion Date
January 15, 2024
Study Completion Date
March 25, 2025
margetuximab
margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle
Retifanlimab
Retifanlimab: anti-PD-1 checkpoint inhibitor 375 mg IV, Day 1 of each 3-week cycle.
Tebotelimab
Tebotelimab: anti PD-1, anti-LAG3 bispecific DART (R) molecule 600 mg IV, Day 1 of each 3-week cycle.
Trastuzumab
Anti-HER2 monoclonal antibody 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle
Chemotherapy
"Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6~Chemotherapy~XELOX chemotherapy Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion~mFOLFOX6 chemotherapy: Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion."
Taipei Medical University Hospital, Taipei City
Chang Gung Memorial Hospital, Keelung, Keelung
Hallym University Sacred Heart Hospital, Anyang-si
Ospedale San Raffaele, Milan
Virginia Cancer Specialists, Fairfax
Mayo Clinic - Jacksonville, Jacksonville
Florida Cancer Specialists North, St. Petersburg
Florida Cancer Specialists South, Fort Myers
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala, Ocala
Sarah Cannon Research Institute, Nashville
Henry Ford Health System, Detroit
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion, Grand Rapids
University of Wisconsin, Madison
Mayo Clinic - Rochester, Rochester
Azienda Ospedaliero-Universitaria Pisana, Pisa
Edward H. Kaplan MD & Associates, Skokie
Institute of Clinical Cancer Research Krankenhaus Nordwest (IKF), Frankfurt
University of Chicago, Chicago
Washington University School of Medicine, St Louis
Nebraska Heme Onc, Lincoln
Stephenson Cancer Center at OUHSC, Oklahoma City
Liuying Chi MeiMedical Hospital, Tainan City
Oncology Consultants, Houston
Kaohsiung Chang Gung MemorialHospital, Kaohsiung City
Utah Cancer Specialists, Salt Lake City
Mayo Clinic - Scottsdale, Scottsdale
The University of New Mexico Comprehensive Cancer Center, Albuquerque
Norris Comprehensive Cancer Center (USC), Los Angeles
UCLA School of Medicine, Santa Monica
City of Hope Comprehensive Cancer Center - Duarte, Duarte
Salinas Memorial, Salinas
Kaiser Permanente, Honolulu
Swedish Cancer Institute, Seattle
Beijing Cancer Hospital, Beijing
Liaoning cancer hospital, Shenyang
National University Hospital (Cancer Institute) -Singapore, Singapore
Jilin Cancer Hospital (Second People's Hospital Of Jilin Province), Changchun
Affiliated Tumor Hospital of Harbin Medical University- the 3rd Affiliated Hospital of Harbin, Harbin
National Cancer Center Singapore, Singapore
Zhongshan Hospital Fudan University, Shanghai
Nanjing University Medical School; Nanjing Drug Tower, Nanjing
The First Affiliated Hospital of Anhui Medical University, Hefei
Anhui Provincial Cancer Hospital, Hefei
Jinan Center Hospital, Jinan
SIR RUN RUN SHAW Hospital, Zhejiang University school of medicine, Hangzhou
Zhejiang Cancer Hospital, Hangzhou
Fujian Medical University - Fujian Provincial Cancer Hospital (Fujian Provincial Tumor Hospital), Fuzhou
Wuhan Union Hospital, Wuhan
Henan Cancer Hospital, Zhengzhou
The First Affiliated Hospital of Zhengzhou University, Zhenzhou
Yale University, New Haven
Massachusetts General Hospital Cancer Center, Boston
Rutgers Cancer Institute of New Jersey, New Brunswick
Hebei cancer hospital (The Fourth Affiliate), Shijiazhuang
Haematologisch-Onkologische Praxis Eppendorf, Hamburg
Universitätsmedizin Mainz, Mainz
Kliniken Maria Hilf GmbH, Mönchengladbach
Istituto Europeo Di Oncologia, Milan
CHA bundang, Gyeonggi-do
Inje University Haeundae Paik Hospital, Haeundae
Seoul National University Bundang Hospital, Seongnam-si
Asan Medical Center, Seoul
Korea University Guro, Seoul
Korea University, Anam Hospital, Seoul
Samsung Medical Center, Seoul
Seoul National University Hospital, Seoul
Yonsei University College of Medicine (Severance Hospital), Seoul
Catholic University of Korea St. Vincent Hospital, Suwon
National Taiwan University, Taipei
Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital, Cambridge
The Christie Hospital NHS Foundation Trust, Manchester
SPSK nr 1 in Lublin, Lublin
Centrum Medyczne MrukMed, Rzeszów
Lead Sponsor
Zai Lab (Shanghai) Co., Ltd.
INDUSTRY
MacroGenics
INDUSTRY