Spots Global Cancer Trial Database for A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
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Trial Identification
Brief Title: A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
Official Title: Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Gastroesophageal Adenocarcinoma (GEA), Biliary Tract Cancer (BTC), and Colorectal Cancer (CRC)
Study ID: NCT03929666
Study Description
Brief Summary: This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC), or colorectal cancer (CRC).
Detailed Description: Part 1 of the study will first evaluate the safety and tolerability of ZW25 plus standard first-line combination chemotherapy (XELOX, FP, or mFOLFOX6 for GEA; mFOLFOX6 with or without bevacizumab for CRC; and CisGem for BTC) and will confirm the recommended dosage (RD) of ZW25 when administered in combination with each of these multi-agent chemotherapy regimens. Then, Part 2 of the study will evaluate the anti-tumor activity of ZW25 plus combination chemotherapy in HER2-expressing GEA, BTC, and CRC.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago, Chicago, Illinois, United States
Cancer and Hematology Centers of Western Michigan, Kalamazoo, Michigan, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Centro de Estudios Clinicos SAGA SpA, Santiago, , Chile
Icegclinic Research & Care, Santiago, , Chile
Meditek Ltda, Santiago, , Chile
CECIM Biocinetic, Santiago, , Chile
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Pusan National University, Busan, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: Phillip Garfin, MD, PhD
Affiliation: Jazz Pharmaceuticals
Role: STUDY_DIRECTOR
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