A Phase II Study of Enfortumab Vedotin in People with Advanced or Metastatic Solid Tumors

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Full Title

An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Purpose

The purpose of this study is to assess the safety and effectiveness of the anticancer drug enfortumab vedotin in people with certain advanced breast and digestive cancers. Enfortumab vedotin delivers a chemotherapy agent directly to cancer cells by attaching to the surface of the cells and releasing the chemotherapy agent inside the cells.

Enfortumab vedotin is approved by the U.S. Food and Drug Administration to treat patients with advanced urothelial cancers (such as bladder and kidney cancers) that continue to grow despite prior treatment. Its use in this study is investigational. Enfortumab vedotin is given intravenously (by vein).

Eligibility

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

  • Participants in this study must have advanced or metastatic hormone receptor-positive HER2-negative breast cancer, triple-negative breast cancer, or cancer of the esophagus, stomach, or junction between the esophagus and stomach. The cancer must have continued to grow despite being treated.
  • At least 2 weeks must pass since completing previous treatments and receiving the study therapy.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Tiffany A. Traina at 646-888-4558.

Protocol

21-327

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators