Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03929666 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
- 20
- Study locations
NCT03929666: Completed Phase 2 study of HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer, sponsored by Jazz Pharmaceuticals.
NCT03929666 is a Phase 2 study of HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 74 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03929666, a Phase 2 study of HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
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.
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 |
What the finished NCT03929666 record still lists
NCT03929666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
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.
NCT03929666 names 20 study sites across 13 states, led by Other, California, Ontario.
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.
What interventions are being tested in trial NCT03929666?
The interventions under investigation include: Capecitabine (DRUG), Cisplatin (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), ZW25 (Zanidatamab) (DRUG).
Who is sponsoring clinical trial NCT03929666?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03929666's enrollment target sits among peer trials
74 920th of 2000 higher than 1,077 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03422731 · 74 participants · Early Phase 1
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
- NCT03804853 · 74 participants · NA
Rehabilitation Following Reverse Total Shoulder Arthroplasty
- NCT04065776 · 74 participants · NA
Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma
- NCT04771156 · 74 participants · Phase 4
Ketorolac in Palatoplasty
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI