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A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Clinical Trial Details

This clinical trial is for men and women who have relapsed or refractory acute myeloid leukemia (AML). 

The purpose of this study is to learn the maximal tolerated dose and/or the recommended dose of Ziftomenib (KO-539) in participants with relapsed or refractory AML.

Ziftomenib is an experimental drug that blocks the menin pathway in hopes of preventing or slowing the leukemia cells from growing and dividing. Investigational means that Ziftomenib has not yet been approved by the United States Food and Drug Administration (FDA).

The study team will let each participant know what dose of ziftomenib they will receive. Ziftomenib is an oral capsule taken by mouth.  

The total participation duration will depend on how well the participants tolerate the study drug. 

Key Eligibility: 

- Patients with refractory or relapsed acute myeloid leukemia (AML) for whom standard therapies are no longer working or are ineligible for any approved standard of care therapies, including hematopoietic stem cell transplant (HSCT).

Detailed eligibility will be reviewed when participants contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Victoria Mendez
212-746-4829
vib9049@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2105023546

ClinicalTrials.gov:

NCT04067336

Sponsor:

KO-MEN-001

Status

Open to Enrollment

Age Group

Adult

Sponsor