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

NCT07617363 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-06-01

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

ATRN-119

ATRN-119 is provided in 50mg and 100mg capsules or 50mg and 250mg tablets and are administered by mouth.

DRUG

Decitabine

Decitabine is provided as a 50mg injection in a single-dose vial.

Sponsors & Collaborators

Principal Investigators

  • Geoffrey L Uy, MD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2030-01-31
Completion
2031-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07617363 on ClinicalTrials.gov