A Phase I Study of CG-806 in People with Acute Myeloid Leukemia

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Full Title

A Phase 1a/b Trial of CG-806 in Patients with Relapsed/Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes

Purpose

The purpose of this study is to find the highest dose of the investigational drug CG-806 that can be given safely in patients with acute myeloid leukemia (AML) that has come back or continues to grow despite prior treatment. CG-806 was designed to slow or stop the activity of enzymes in cancer cells called kinases. CG-806 blocks several kinases, including the FLT3 kinase, which plays a role in the growth of some leukemia cells. CG-806 also blocks other kinases involved in leukemia cell growth.

Drugs that block only the FLT3 kinase usually eventually stop working as leukemia cells learn to turn on other pathways that lead to their growth. Because CG-806 is a drug that strongly blocks FLT3 as well as other kinases involved in leukemia growth, researchers think that it may be a more effective treatment for AML than currently approved drugs that block only one kinase or those that block many kinases less strongly. CG-806 is taken orally (by mouth).

Who Can Join

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 continues to grow despite prior treatment.
  • At least 2 weeks must pass since the completion of previous chemotherapy and 4 weeks since immunotherapy 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. Aaron Goldberg at 646-608-3752.

Protocol

20-438

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04477291