NCT03929666Phase 2Completed

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-08-30Actual

Enrollment · participants74Actual

Source updated2025-09-12Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

Treatments or interventions studied

ZW25 (Zanidatamab)Drug
CapecitabineDrug
CisplatinDrug
FluorouracilDrug
LeucovorinDrug
OxaliplatinDrug
BevacizumabDrug
GemcitabineDrug

Primary outcomes · main study measures

Read the study measures

measure: Incidence of dose-limiting toxicities (DLTs) (Part 1); description: Number of participants who experienced a DLT. DLTs include adverse events considered to be related to study treatment, including the evaluated dose level of ZW25, any component or combination of the components of a chemotherapy regimen, or the combination of ZW25 plus a chemotherapy regimen.; timeFrame: Up to 6 weeks; measure: Incidence of adverse events (Part 1); description: Number of participants who experienced an adverse event; timeFrame: Up to 11 months; measure: Incidence of lab abnormalities (Part 1); description: Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology and chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.; timeFrame: Up to 11 months; measure: Objective response rate (ORR) (Part 2); description: Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; timeFrame: Up to 10 months

History coverage

Imported research includes version dates later than the current official API record (2025-09-12). Disputed observations are retained for audit and excluded from trusted change feeds and sponsor statistics. Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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