IRB #

STUDY00016964

Title

A Phase 1/1b, Multicenter, Open-label, Dose-Escalation Study of
FT-2102 as a Single Agent and in Combination with Azacitidine in
Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome
with an IDH1 Mutation

Principal Investigator

Elie Traer

Study Purpose

The main purpose of this study is to test the safety of a study drug called FT-2102. This drug has been tested in animals but not yet in people. This study tests different doses of the drug to see which dose is safer and find out what effects (good and bad), if any, it has on people with AML or MDS.

Medical Condition(s)

Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)

Eligibility Criteria

Eligible subjects must meet the following:
-Be at least 18 years or older,
-Have been diagnosed with MDS or AML
-Have the IDH1 gene mutation,
-Your disease has not responded to previous treatment or, if you have MDS, it has not been previously treated.

Age Range

18 - N/A

Healthy Volunteers Needed

No

Duration of Participation

Your study participation may last up to 52 weeks (1 year).

You will receive the study drug once or twice daily until you experience side effects that you cannot tolerate, or your disease worsens, or you or your investigator decide to stop.

You may stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the investigator and your regular doctor first.

In the event that you withdraw from the study (stop being in the study), you will be asked to continue to be followed and clinical data will continue to be collected from your medical records. If you stop taking the study drug, additional blood (about 4 teaspoons) for laboratory tests may need to be drawn about 28 days after your last dose of study drug.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

FORMA Therapeutics, Inc.

Recruitment End

01/01/2027

Compensation Provided

No


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