A Phase I Study of ZW49 in Inoperable or Metastatic HER2-Positive Cancers

Full Title

A Phase 1 Study of ZW49 in Patients with Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers

Purpose

The purpose of this study is to find the highest dose of the investigational drug ZW49 that can be given safely in patients with inoperable or metastatic cancers that have the HER2 protein on their cell surfaces. ZW49 is a type of drug called an antibody-drug conjugate (ADC). ADCs have two parts: an antibody that targets cancer cells and a chemotherapy drug that kills cancer cells.

The antibody part of ZW49 sticks to the HER2 protein. The chemotherapy drug is called ZD02044. When the antibody part of ZW49 attaches to HER2, ZD02044 is released inside the cancer cell and the cell is destroyed. ZW49 is 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 inoperable or metastatic breast cancer, cancer of the junction between the esophagus and stomach (gastroesophageal cancer), or other solid tumor that expresses HER2 and has continued to grow despite standard treatments, including standard HER2-targeting drugs (trastuzumab, pertuzumab, ado-trastuzumab emtansine).
  • Patients should recover from the serious side effects of prior treatments before entering the study. At least 3 weeks must pass since the completion of prior HER2-targeting therapies.
  • 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 the Early Drug Development service at 646-888-4226. The Principal Investigator for this study is Dr. Komal Jhaveri.

Protocol

19-148

Phase

I

Investigator

Co-Investigators