A Phase II Study of Trastuzumab Deruxtecan in People with HER2-Positive, Inoperable or Metastatic Stomach or Gastro-Esophageal Junction Cancer

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Full Title

A Phase 2, Open-Label, Single-Arm Trial of Trastuzumab Deruxtecan (DS-8201A) in HER2-Positive, Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab Containing Regimen

Purpose

Trastuzumab is an anticancer medication that targets HER2, a protein overproduced by some cancers of the stomach (gastric cancers) and the junction between the stomach and esophagus (gastro-esophageal junction or GEJ cancers). However, in some patients, the cancer continues to grow despite trastuzumab therapy.

In this study, researchers are evaluating the safety and effectiveness of the investigational drug trastuzumab deruxtecan (also known as DS-8201A) in patients with stomach and GEJ cancers that continue to grow despite trastuzumab treatment. Trastuzumab deruxtecan is an antibody drug conjugate (ADC). ADCs have two parts: the antibody targets cancer cells and the other part (a chemotherapy drug attached to the antibody) kills cancer cells.

Trastuzumab, the antibody part, binds to HER2 on stomach and GEJ cancer cells. Deruxtecan is the cell-killing part. When trastuzumab sticks to HER2, deruxtecan is released and kills the cancer cell from within. Trastuzumab deruxtecan 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 stomach of GEJ cancer that is positive for HER2 and has continued to grow despite initial treatment that included trastuzumab.
  • Patients should recover from the serious side effects of prior treatment before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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

19-377

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators