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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07617363
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ATRN-119 — DRUG
    ATRN-119 is provided in 50mg and 100mg capsules or 50mg and 250mg tablets and are administered by mouth.
  • Decitabine — DRUG
    Decitabine is provided as a 50mg injection in a single-dose vial.

Study Details

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).

Key Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
Jan 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Dose Escalation Dose Level 1: ATRN-119 + Decitabine
    Patients will take 750 mg of ATRN-119 by mouth once per day on Days 1-28 of each 28-day cycle and 20 mg/m\^2 of decitabine given intravenously (IV) on Days 1-5. Patients may continue treatment for up to 24 cycles, or until disease progression, unacceptable toxicity, or withdrawal.
  • Experimental: Part A Dose Escalation Dose Level 2: ATRN-119 + Decitabine
    Patients will take 1000 mg of ATRN-119 by mouth once per day on Days 1-28 of each 28-day cycle and 20 mg/m\^2 of decitabine given intravenously (IV) on Days 1-5. Patients may continue treatment for up to 24 cycles, or until disease progression, unacceptable toxicity, or withdrawal.
  • Experimental: Part A Dose Escalation Dose Level -1: ATRN-119 + Decitabine
    Patients will take 500 mg of ATRN-119 by mouth once per day on Days 1-28 of each 28-day cycle and 20 mg/m\^2 of decitabine given intravenously (IV) on Days 1-5. Patients may continue treatment for up to 24 cycles, or until disease progression, unacceptable toxicity, or withdrawal.
  • Experimental: Part B Dose Expansion: ATRN-119 + Decitabine
    Patients will take the recommended phase 2 dose (RP2D) of ATRN-119 as determined in the dose escalation portion of the trial once per day on Days 1-28 of each 28-day cycle and 20mg/m\^2 of decitabine given intravenously (IV) on Days 1-5. Patients may continue treatment for up to 24 cycles, or until disease progression, unacceptable toxicity, or withdrawal.

Primary Outcome Measure

Number and grade of treatment-emergent adverse events (TEAEs) as assessed via CTCAE v6.0 [ Time Frame: From start of treatment until 30 days after last dose of ATRN-119 (approximately 23 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Geoffrey L Uy, MD
[email protected]
314-747-8519
Geoffrey L Uy, MD (PRINCIPAL_INVESTIGATOR)
Daniel C Link, MD (SUB_INVESTIGATOR)
J Scott Beeler, MD, PhD (SUB_INVESTIGATOR)
Fei Wan, PhD (SUB_INVESTIGATOR)

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