A Phase I/II Study of MCLA-128 in People with Advanced Solid Tumors with NRG1 Gene Fusions

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Full Title

A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors

Purpose

The purpose of this study is to assess the effectiveness of the investigational drug MCLA-128 in people with advanced solid tumors that contain a gene fusion involving the NRG1 gene. MCLA-128 is a bispecific antibody that can attach to proteins on the surface of cancer cells and immune cells. MCLA-128 is designed to recognize two different proteins: HER2 and HER3.

An NRG1 fusion can lead to activation of HER receptors which can cause cancer cell growth. HER2 and HER3 sit on the surface of cancer cells and send signals to help these cells grow and survive. When MCLA-128 links to HER2 and HER3, it stops them from working properly, and the cancer cells no longer receive the signals they need to grow.

MCLA-128 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 an advanced solid tumor with an NRG1 fusion.
  • 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 and to inquire about eligibility for this study, please contact Dr. Alison Schram at 646-888-5388.

Protocol

19-378

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators