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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

Clinical Trial Details

HER2-positive cancer tests positive for a protein called HER2 which supports the growth of cancer cells, and trastuzumab deruxtecan blocks HER2-specific cell growth and shows anti-tumor activity. There is no standard second-line therapy for HER2-positive advanced gastric/GEJ cancer after progression following a first treatment with trastuzumab.

This study is being carried out to see if a potential new drug called trastuzumab deruxtecan (referred to as the study drug in the rest of this document) is effective and safe in treating your type of gastric cancer. Although Trastuzumab is only antibody, Trastuzumab deruxtecan is an antibody drug conjugate, which means it is made up of 2 parts; a drug and an antibody (type of protein). The antibody part binds to cancer cells that have the HER2 receptor and delivers the drug part into the cancer cell. The drug part has strong anti-cancer activity. According to early clinical trial, patient who had progressed standard of care including Trastuzumab had responded by over 40% based on investigator assessment.

Trastuzumab deruxtecan is an investigational drug. An investigational drug is a medication that is being studied and has not yet been approved by the United States Food and Drug Administration (FDA). The FDA allows trastuzumab deruxtecan to be used only in research.

Key Eligibility: 
  • Open to men and women above the age of 18 who have pathologically documented gastric or GEJ cancer that is unresectable or metastatic
  • Have experienced disease progression during or after first-line therapy with a trastuzumab-containing regimen (brand or approved biosimilar)

Detailed eligibility will be reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2004021788

ClinicalTrials.gov:

NCT04014075

Sponsor:

DS8201-A-U205

Status

Open to Enrollment

Age Group

Adult

Sponsor