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

Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Gastroesophageal Adenocarcinoma (GEA), Biliary Tract Cancer (BTC), and Colorectal Cancer (CRC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Part 1 of the study will first evaluate the safety and tolerability of ZW25 plus standard first-line combination chemotherapy (XELOX, FP, or mFOLFOX6 for GEA; mFOLFOX6 with or without bevacizumab for CRC; and CisGem for BTC) and will confirm the recommended dosage (RD) of ZW25 when administered in combination with each of these multi-agent chemotherapy regimens. Then, Part 2 of the study will evaluate the anti-tumor activity of ZW25 plus combination chemotherapy in HER2-expressing GEA, BTC, and CRC.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-29
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2019-04-29
• Last updated: 2025-09-12

Locations

23 sites across 4 countries: United States, Canada, Chile, South Korea

Regulatory

• FDA-regulated drug study