AgingResearch.NewsJoin free

Phase 1Not yet recruiting

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

A Phase I Study of ATRN-119, an ATR Inhibitor, in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS

Sponsor
Washington University School of Medicine (Academic or other)
Enrollment
36 planned
Conditions
Acute Myeloid Leukemia; High-risk Myelodysplastic Syndrome
Interventions
ATRN-119; Decitabine
Ages
adults, older adults
Registry
NCT07617363

Full record on ClinicalTrials.gov

From the registry

This single-center, open-label, phase I study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antileukemic activity of ATRN-119 (mosipasertib) alone and in combination with decitabine in patients with TP53-mutated AML or higher-risk myelodysplastic syndrome (HR-MDS). The primary objective is to identify the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE) of ATRN-119 (mosipasertib) plus decitabine. The study is based on the hypothesis that ATR inhibition with ATRN-119 (mosipasertib) will enhance sensitivity to decitabine in TP53-mutated disease, resulting in deeper and more durable clinical responses.

Primary outcomes

  • Number and grade of treatment-emergent adverse events (TEAEs) as assessed via CTCAE v6.0 (All Patients)
  • Incidence of dose-limiting toxicities (DLTs) during Cycle 1 as assessed via CTCAE v6.0 (All Patients)

History

  1. Study completion expected

  2. Primary completion expected

  3. Expected to start

  4. Last registry update

  5. Registered