A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastroesophageal Adenocarcinoma

Official Title

Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastroesophageal Adenocarcinoma (GEA)

Summary:

This is a multicentre, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumour activity of ZW25 (zanidatamab) plus physician's choice of combination chemotherapy in HER2-expressing gastroesophageal adenocarcinoma (GEA). Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA.

Trial Description

Primary Outcome:

• Incidence of dose-limiting toxicities (DLTs) (Part 1)
• Incidence of adverse events (Part 1)
• Incidence of lab abnormalities (Part 1)
• Objective response rate (ORR) (Part 2)

Secondary Outcome:

• Objective response rate (ORR) (Part 1)
• Disease control rate (Parts 1 and 2)
• Duration of response (Parts 1 and 2)
• Clinical benefit rate (Parts 1 and 2)
• Progression-free survival (Parts 1 and 2)
• Overall survival (Parts 1 and 2)
• Incidence of anti-drug antibodies (ADAs) (Parts 1 and 2)
• End of infusion concentration of ZW25 (Parts 1 and 2)
• Maximum serum concentration of ZW25 (Parts 1 and 2)
• Trough concentration of ZW25 (Parts 1 and 2)
• Incidence of adverse events (Part 2)
• Incidence of lab abnormalities (Part 2)

Part 1 of the study will first evaluate the safety and tolerability of ZW25 plus physician's choice of first-line combination chemotherapy (FP, mFOLFOX6, or XELOX) 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-tumour activity of ZW25 plus physician's choice of combination chemotherapy in HER2-high GEA.

View this trial on ClinicalTrials.gov