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
Completed · Phase 2
Conditions studied: HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
In brief
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).
Key facts
- Study ID
- NCT03929666
- Run by
- Jazz Pharmaceuticals
- People needed
- 74
- Starts
- 2019-08-29
- Expected to finish
- 2025-08-30
- Last updated by the study team
- 2025-09-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
- H. Lee Moffitt Cancer Center — Tampa, Florida, United States
- University of Chicago — Chicago, Illinois, United States
- The Cancer and Hematology Centers — Grand Rapids, 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
- The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada
- Princess Margaret Cancer Center — Toronto, Ontario, Canada
- Centro de Investigacion Clinica SAGA — Santiago, Chile
- Icegclinic Research & Care — Santiago, Chile
- CECIM Biocinetic — Santiago, Chile
- Centro Internacional de Estudios Clínicos — Santiago, Chile
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
- Pusan National University — Busan, South Korea
- Korea University Anam Hospital — Seoul, South Korea
- Seoul National University Hospital — Seoul, South Korea
- Severance Hospital — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
Full record on ClinicalTrials.gov
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