A Phase I/II Study of IMC-C103C Alone or with Atezolizumab Immunotherapy in Patients with Solid Tumors Containing Certain Proteins

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Full Title

A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as a Single Agent and in Combination with Atezolizumab in HLA-A*0201-positive Patients with Advanced MAGE-A4-positive Cancer

Purpose

The purpose of this study is to find the highest dose of the investigational drug IMC-C103C that can be given alone and in combination with atezolizumab immunotherapy in patients with advanced non-small cell lung cancer (NSCLC), head and neck cancer, esophageal cancer, gastric cancer, urothelial (bladder) cancer, ovarian cancer, or synovial sarcoma that cannot be removed by surgery and has not responded to other treatments. Moreover, patients must have a protein in their blood called HLA-A*02:01 and a protein in their tumors called MAGE-A4.

IMC-C103C is an immunotherapy drug designed to work in cancers having these proteins. It helps T cells recognize key targets on tumor cells (in this case, the proteins MAGE-A4 and HLA-A*02:01) and destroy them. Atezolizumab also has the ability to boost the power of the immune system to find and kill cancer cells. Patients will receive IMC-C103C alone or with atezolizumab. 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 advanced NSCLC, head and neck cancer, esophageal cancer, gastric cancer, urothelial cancer, ovarian cancer, or synovial sarcoma that cannot be removed by surgery and has not responded to other treatments.
  • Patients must have a protein in their blood called HLA-A*02:01 and a protein in their tumors called MAGE-A4.
  • Patients should 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 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. Neil Segal at 646-888-4187.

Protocol

19-358

Phase

I/II

Investigator

Co-Investigators