A Phase I Study of Immunotherapy with GWN323 Alone and with PDR001 in Patients with Advanced Cancers and Lymphomas

Full Title

A Phase I/Ib Open-label, Multi-center, Dose Escalation Study of GWN323 (anti-GITR) as a Single Agent and in Combination with PDR001 (anti-PD-1) in Patients with Advanced Solid Tumors and Lymphomas

Purpose

GWN323 is a investigational immunotherapy drug that blocks a protein on immune cells called GITR. GWN323 is designed to stimulate the immune cells to find and kill cancer cells. PDR001 is another investigational drug that boosts the power of the immune system to attack cancer cells, but it does so by blocking a protein called PD-1, which normally prevents cancer-fighting immune cells from working properly.

In this study, researchers want to find the highest doses of GWN323 given alone and in combination with PDR001 in patients with advanced cancers and lymphomas that have continued to grow despite prior treatment. Both drugs are 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 an advanced cancer (such as non-small cell lung cancer or head and neck cancer) or lymphoma that has continued to grow despite at least one prior regimen of therapy.
  • At least 2 weeks must pass between the completion of previous treatment and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alexander Lesokhin at 212-639-3069.

Protocol

16-1447

Phase

I

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