ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS

This is a single-center, open-label, phase I study with dose escalation and dose expansion testing the combination of ATRN-119 and decitabine in patients with TP53-mutated acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS). The dose escalation phase will enroll patients with previously untreated, relapsed, or refractory AML or HR-MDS, regardless of TP53 alteration status, with the primary objective of determining safety and tolerability of ATRN-119 plus decitabine. The dose expansion phase will only enroll patients with previously untreated AML or HR-MDS with a TP53 alteration, with the primary objective of identifying the recommended phase 2 dose (RP2D).

NCT Number	NCT07617363
Lead Sponsor	Washington University School of Medicine Collaborators: Aprea Therapeutics, National Cancer Institute (NCI)
Conditions	Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Enrollment	27 participants
Start Date	2026-08-31
Primary Completion	2030-01-31 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-01