A Safety and Efficacy Study of ZW25 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 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)
  • 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 (XP, 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

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society