A Phase 1b Study of Eganelisib Alone or With Cytarabine in People With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Full Title

A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination with Cytarabine in Patients with Relapsed/Refractory Acute Myeloid Leukemia

Purpose

Researchers want to find the best dose of eganelisib when used alone and with cytarabine to treat leukemia. The people in this study have acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) that has come back or keeps growing after treatment.          

Eganelisib works by blocking enzymes called PI3 kinases. These enzymes may be too active or found at high levels in some types of cancer cells, including AML and MDS. By blocking these enzymes, eganelisib may help slow or stop the growth of your cancer. It may also work well when combined with cytarabine.

Eganelisib is taken orally (by mouth). If you also get cytarabine, it will be given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have AML or HR-MDS that came back or keeps growing after treatment.
  • Have recovered from the serious side effects of prior therapies before getting the study treatment.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Xin Wang’s office at 646-608-4365.

Protocol

25-203

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06533761