A Phase I/II Study of Immunotherapy with JTX-2011 Alone or with Nivolumab in Patients with Advanced Solid Tumors

Full Title

Phase 1/2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX-2011 Alone or in Combination With Nivolumab in Adult Subjects with Advanced Refractory Solid Tumor Malignancies

Purpose

Nivolumab is a form of immunotherapy. It boosts the body's immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body's white blood cells. Nivolumab blocks PD-1, enhancing the body's ability to detect and destroy cancer cells.

Researchers are looking for new ways to further boost the immune response against cancer. JTX-2011 is an investigational drug that binds to a protein called ICOS, stimulating T cells to fight cancer cells. It is hoped that JTX-2011 will be an effective new therapy for treating advanced cancers. In addition, it is hoped that combining JTX-2011 with another immunotherapy drug like nivolumab will be more effective than nivolumab alone.

In this study, researchers are looking for the highest doses of JTX-2011 that can be given safely alone or with nivolumab in patients with advanced solid tumors, and also observing the effectiveness of these drugs. Patients will receive JTX-2011 alone or with nivolumab. 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 solid tumor that continues to grow despite at least one prior regimen of therapy. Examples include head and neck cancers, non-small cell lung cancer, stomach cancer, triple-negative breast cancer, and melanoma.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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. Margaret Callahan at 646-888-3579.

Protocol

16-966

Phase

I/II

Investigator

Co-Investigators

Locations