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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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
74actual
Sites
23
Countries
Canada, Chile, South Korea +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-08-29 | actual | When the study began enrolling |
| Primary completion | 2025-08-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-30 | actual | The whole study's end, after follow-up |
| First posted | 2019-04-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
Interventions
- Drug: ZW25 (Zanidatamab)
- Drug: Capecitabine
- Drug: Cisplatin
- Drug: Fluorouracil
- Drug: Leucovorin
- Drug: Oxaliplatin
- Drug: Bevacizumab
- Drug: Gemcitabine
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose-limiting toxicities (DLTs) (Part 1)
measured Up to 6 weeks
Incidence of adverse events (Part 1)
measured Up to 11 months
Incidence of lab abnormalities (Part 1)
measured Up to 11 months
Objective response rate (ORR) (Part 2)
measured Up to 10 months
Publications
- PMID 40473445 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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