A Phase I/II Study of REGN7075 plus Cemiplimab Immunotherapy in People with Advanced Solid Tumor Cancers

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Full Title

A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination with Cemiplimab in Patients with Advanced Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy drug REGN7075 that can be given alone and in combination with cemiplimab in people with inoperable or metastatic solid tumors. Patients will either receive REGN7075 alone followed by REGN7075 plus cemiplimab, or only combination treatment with REGN7075 plus cemiplimab. Both drugs are given intravenously (by vein).

REGN7075 is a bispecific antibody, which is designed to recognize and attach to two different proteins at the same time: one protein on the surface of cancer cells and one on the surface of immune system cells called T cells. REGN7075 targets the proteins EGFR on cancer cells and CD28 on T cells. Researchers think that REGN7075 may boost the immune system to fight cancer cells by activating T cells to destroy the tumor.

Cemiplimab takes the brakes off the immune response so the immune system can detect and destroy cancer cells. Its use with REGN7075 is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an inoperable or metastatic solid tumor cancer that cannot be successfully treated with standard therapies and is amenable to treatment with immunotherapy.
  • Patients should recover from the serious side effects of prior therapies before receiving the study treatment.
  • 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

21-246

Phase

I/II

Investigator

Co-Investigators