A Phase I Study of BAY 2402234 in Patients with Advanced Myeloid Cancers

Full Title

An Open-Label, Multicenter Phase 1 Study To Characterize the Safety, Tolerability, Preliminary Anti-Leukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY 2402234 In Patients With Advanced Myeloid Malignancies

Purpose

The purpose of this study is to find the highest dose of an investigational drug called BAY 2402234 that can be used safely in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) that has come back or continued to grow despite standard treatment.

BAY 2402234 blocks an enzyme called DHODH, which is believed to play an active role in cancer. It is thought that by blocking DHODH, BAY 2402234 will stop or slow the growth of cancer cells. BAY 2402234 is taken orally, as either a solution or a tablet.

Eligibility

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

  • Patients must have AML, MDS, or CMML that has come back or continued to grow despite standard therapy.
  • Patients must recover from the serious side effects of previous 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 212-639-3314.

Protocol

18-151

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators