Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT03929666 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Cisplatin
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG ZW25 (Zanidatamab)
Study Locations (20)
Other
- Centro de Investigacion Clinica SAGA — Santiago
- Icegclinic Research & Care — Santiago
- CECIM Biocinetic — Santiago
- Centro Internacional de Estudios Clínicos — Santiago
- Pusan National University — Busan
- Korea University Anam Hospital — Seoul
California
- USC/Norris Comprehensive Cancer Center — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
Ontario
- The Ottawa Hospital Cancer Centre — Ottawa
- Princess Margaret Cancer Center — Toronto
Florida
- H. Lee Moffitt Cancer Center — Tampa
Illinois
- University of Chicago — Chicago
Michigan
- The Cancer and Hematology Centers — Grand Rapids
Nebraska
- Nebraska Methodist Hospital — Omaha
New York
- Memorial Sloan Kettering Cancer Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2025-08-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03929666
The ClinicalTrials.gov registry entry for NCT03929666 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions — of which Capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03929666 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03929666 about?
NCT03929666 is a clinical study titled "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". 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 w...
What is the current status of trial NCT03929666?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2019-08-29. Estimated completion is 2025-08-30.
What conditions does trial NCT03929666 study?
This clinical trial studies the following conditions: HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03929666?
The interventions under investigation include: Capecitabine (DRUG), Cisplatin (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), ZW25 (Zanidatamab) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03929666?
This trial is sponsored by Jazz Pharmaceuticals, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03929666 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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