A Phase I Study of FHD-286 in People with Recurrent or Persistent Acute Myeloid Leukemia or Myelodysplastic Syndromes

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Full Title

A Phase 1, Multicenter, Open-Label, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered FHD-286 in Subjects with Advanced Hematologic Malignancies

Purpose

The purpose of this study is to find the highest dose of the investigational drug FHD-286 that can be given safely in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) that came back or continued to progress despite treatment. FHD-286 blocks the activity of two proteins (BRG1 and BRM) that promote cancer cell growth. By blocking these proteins, FHD-286 may stop the growth of AML or MDS. It is taken orally (by mouth).

Eligibility

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

  • Patients must have AML or MDS that came back or continued to progress despite treatment.
  • Patients should recover from the serious side effects of prior treatments before entering 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. Eytan Stein at 646-608-3749.

Protocol

21-267

Phase

I

Investigator

Co-Investigators