Clinical trialNCT03929666CompletedPhase 2Interventional

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

SponsorJazz PharmaceuticalsEnrollment74HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Phillip Garfin, MD, PhD
Jazz Pharmaceuticals
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

23 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

the Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada

Chile

Cecim Biocinetic
Santiago, Chile
Centro Internacional de Estudios Clínicos
Santiago, Chile
Centro de Investigacion Clinica Saga
Santiago, Chile
Icegclinic Research & Care
Santiago, Chile

South Korea

Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Pusan National University
Busan, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Bevacizumab →Capecitabine →Cisplatin →Fluorouracil →Gemcitabine →Leucovorin →Oxaliplatin →ZW25

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Aug 2019
Primary completion: 30 Aug 2025
Completion: 30 Aug 2025
Last update posted: 12 Sept 2025
Registered enrollment: 74
Registry id: NCT03929666

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.