A Phase II Study of ZW25 and Chemotherapy as Initial Treatment in Patients with HER2-Positive Gastroesophageal Cancer

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Full Title

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

Purpose

Some cancers of the esophagus and stomach produce a protein called HER2 that drives their growth. The usual treatment for these cancers is a drug that targets HER2, called trastuzumab, combined with chemotherapy. In this study, researchers want to see if adding an investigational drug called ZW25 to standard chemotherapy makes it more effective in patients newly diagnosed with inoperable or metastatic HER2-positive gastroesophageal cancer. They also want to find the highest dose of ZW25 that can be given safely with standard chemotherapy.

ZW25 is a type of drug called a bispecific antibody. It has been designed to attach to two different parts of the HER2 protein on the surface of cancer cells. The researchers think that attaching ZW25 to the HER2 protein will remove this protein from the cancer cells and boost the immune system’s ability to kill these cells.

Patients in this study will receive a combination of standard chemotherapy drugs in addition to ZW25. All treatments are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have HER2-positive gastroesophageal cancer that is inoperable or metastatic and has not been previously treated with a drug that targets HER2 (such as trastuzumab).
  • If a patient has had prior anticancer therapy, it must have been completed at least 6 months before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Geoffrey Ku at 646-888-4588.

Protocol

19-222

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators