IRB #

STUDY00016338

Title

A Phase 1/1b Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 alone and in combination with cytarabine (Ara-C) in Patients with Relapsed/Refractory Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome With Wild-Type TP53

Principal Investigator

Uma Borate

Study Purpose

This study is testing the study drug ALRN-6924 alone and in combination with cytarabine (Ara-C) in Acute Myeloid Leukemia (AML) or Advanced Myelodysplastic Syndrome (MDS). The purpose is to test the safety of the study drug at different doses to find out what effects, if any, it has on people with AML or MDS. The p53 protein is a naturally occurring molecule that helps the body defend against damaged cells growing and multiplying abnormally. The study drug is being studied to see if it will help increase the activity of a normal p53 protein.

Medical Condition(s)

Acute Myeloid Leukemia (AML) or Advanced Myelodysplastic Syndrome (MDS).

Eligibility Criteria

Eligible subjects must meet the following:
-Be at least 18 years or older,
-Have been diagnosed with AML or MDS, and
-Your disease has not responded to previous treatment

Age Range

18 - n/a

Healthy Volunteers Needed

No

Duration of Participation

You may receive the study drug until you decide to stop or your investigator feel you should stop participating in the study. After you finish receiving the study drug, your investigator will continue to watch you for side effects and follow your condition for about 30 days.

Minors Included

No

Contact

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

Sponsor

Aileron Therapeutics, Inc.

Recruitment End

01/01/2026

Compensation Provided

No


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