A Phase I Study of AMG 427 in People with Recurrent or Persistent Acute Myeloid Leukemia

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Full Title

A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability,Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Purpose

The purpose of this study is to find the highest dose of the investigational drug AMG 427 that can be given safely in patients with acute myeloid leukemia (AML) that has come back or continued to grow despite prior treatment. AMG 427 is a “bispecific antibody,” which means it attaches to two different proteins. In the case of AMG 427, it attaches to AML cells as well as T cells, which are important cells in the immune system.

Researchers believe that AMG 427 may increase the immune system’s ability to fight cancer by activating T cells to target and kill cancer cells. AMG 427 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 AML that has come back or continued to grow despite prior treatment.
  • At least 2 weeks must pass between the completion of previous therapies and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 212-639-3842.

Protocol

19-376

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators