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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-09-12

No results posted yet for this 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

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

Interventions

DRUG

ZW25 (Zanidatamab)

* Part 1: administered IV at dose levels and schedules determined by the Safety Monitoring Committee (SMC) * Part 2: RD identified in Part 1

DRUG

Capecitabine

Administered orally twice daily (PO bid)

DRUG

Cisplatin

Administered IV

DRUG

Fluorouracil

Administered IV

DRUG

Leucovorin

Administered IV

DRUG

Oxaliplatin

Administered IV

DRUG

Bevacizumab

Administered IV

DRUG

Gemcitabine

Administered IV

Sponsors & Collaborators

Principal Investigators

  • Phillip Garfin, MD, PhD · Jazz Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-29
Primary Completion
2025-08-30
Completion
2025-08-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Chile
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03929666 on ClinicalTrials.gov