A Phase I/II Study of IMCnyeso Immunotherapy in People with Advanced Cancer

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Full Title

A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA-A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, as a Single Agent in HLA-A*0201 Positive Patients with Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy drug IMCnyeso that can be given to people with advanced non-small cell lung cancer (NSCLC), melanoma, bladder cancer, and synovial sarcoma. IMCnyeso was designed to activate the immune system to detect and fight tumor cells.

Tumors can avoid being detected by the immune system by inactivating immune cells called T cells and preventing the immune system from recognizing cancer cells. IMCnyeso helps T cells recognize key targets (the proteins NY-ESO-1 and LAGE-1A) on tumor cells. In addition to assessing the safety of IMCnyeso, this study will also see how well the drug works to help T cells recognize and destroy tumor cells. IMCnyeso 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 advanced NSCLC, melanoma, bladder cancer, or synovial sarcoma that continues to grow or came back despite prior treatment.
  • Patients’ tumors must be positive for HLA-A*02:01 and NY-ESO-1 and/or LAGE-1A. This testing can be done at MSK.
  • At least 2 weeks must pass between the completion of prior therapies and entry into 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 open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sandra P. D’Angelo at 646-888-4159.

Protocol

19-285

Phase

I/II

Investigator

Co-Investigators