RecruitingPhase 1NCT06616636

A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)


Sponsor

M.D. Anderson Cancer Center

Enrollment

24 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A non-randomized phase Ib study of PC14586 (PMV therapeutics) in patients diagnosed with TP53Y220C-mutant myeloid malignancies, including AML and MDS.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the combination of rezatapopt (a drug that reactivates the tumor-suppressing function of the p53 protein) and azacitidine (a chemotherapy drug) in people with certain blood cancers — specifically acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) — that carry a specific genetic mutation called TP53 Y220C. These cancers have relapsed or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older - You have AML or MDS that has relapsed or did not respond to prior treatment - Your tumor has the specific TP53 Y220C mutation confirmed by an approved lab test - You are in reasonable general health (ECOG score ≤ 2) - Your liver, kidneys, and other organs are functioning adequately - You are not considered a good candidate for intensive chemotherapy **You may NOT be eligible if...** - You do not have the TP53 Y220C mutation - You have had certain prior stem cell transplant complications - Your organ function does not meet the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine

Given by IV

DRUGRezatapopt

Given orally with food


Locations(1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

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NCT06616636


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