drugset
drugset / Trial / NCT03929666

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 ↗

Phase 2 Completed 74 enrolled Jazz Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2019-08-29
Primary completion
2025-08-30
Completion
2025-08-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Zanidatamab Monoclonal antibody 20 mg/kg —
Subject Zanidatamab Monoclonal antibody 30 mg/kg —
Subject Zanidatamab Monoclonal antibody 1200 mg —
Subject Zanidatamab Monoclonal antibody 1600 mg —
Subject Zanidatamab Monoclonal antibody 1800 mg —
Subject Zanidatamab Monoclonal antibody 2400 mg —
Background Bevacizumab Monoclonal antibody — Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Cisplatin Other / unclassified 80 mg/m2 Intravenous
Background Gemcitabine Small molecule — Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 800 mg/m2 Intravenous
Background fluorouracil Small molecule 1200 mg/m2 Intravenous

Indications

gastroesophageal adenocarcinoma