A Phase I Study of MCLA-145 in People with Advanced or Metastatic Solid Tumors

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Full Title

A Phase 1, Open-Label, Dose-Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MCLA-145 in Participants with Select Advanced or Metastatic Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug MCLA-145 that can be given safely in patients with advanced and metastatic solid tumors that persist despite prior treatment. MCLA-145 is a bispecific antibody that can attach to two different proteins on the surface of cancer cells and on the surface of immune cells (such as T cells).

Researchers designed MCLA-145 to attach only to cancer cells and to T cells. T cells help the body identify and attack cancer cells. MCLA-145 may increase the immune system’s ability to fight cancer by activating cells in the immune system to target and kill cancer cells while limiting damage to normal cells. It 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 or metastatic solid tumor that continues to grow despite up to four prior regimens of therapy. Patients may not have received more than one prior regimen of immunotherapy.
  • Patients should recover from the serious side effects of previous 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. Chrisann Kyi at 646-888-4221.

Protocol

19-187

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators