A Phase I Study of Mogamulizumab (KW-0761) in Patients with Advanced Solid Tumors

Full Title

A Phase I/II Study of the Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects with Advanced and/or Metastatic Solid Tumors

Purpose

Mogamulizumab (also called KW-0761) is an antibody designed to reduce cancer growth by targeting a protein on white blood cells (“regulatory T cells”) called CCR4. These T cells can promote cancer growth, and mogamulizumab is designed to eliminate them. This drug is already approved in Japan for treating patients with T-cell leukemia-lymphoma.

Doctors are interested in learning if mogamulizumab is also effective against solid tumors. In this study, researchers want to find the highest dose of mogamulizumab that can be given safely in patients with inoperable solid tumors that have metastasized (spread) to other parts of the body despite therapy. Mogamulizumab 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 a metastatic solid tumor that has continued to grow despite prior therapy.
  • At least 30 days must pass since the completion of prior therapies and entry into the study.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jedd Wolchok at 646-888-2395.

Protocol

14-135

Phase

I/II

Investigator

Co-Investigators

Locations