Back to search results

Study of ASTX727 for Malignant Peripheral Nerve Sheath Tumors (MPNST)

This study is testing ASTX727 in people with advanced, unresectable, or metastatic Malignant Peripheral Nerve Sheath Tumors (MPNST) that have a specific genetic change called a PRC2 loss. You may be eligible if you are at least 16 years old and your MPNST has progressed after at least one standard treatment. ASTX727 combines two drugs, cedazuridine and decitabine, which are designed to target and disrupt the growth of cancer cells with this PRC2 mutation. Researchers believe this combination allows decitabine to work more effectively. The main goal is to see how many participants experience a clinical benefit after 16 weeks of treatment.

Study design
This study plans to enroll 25 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You would self-administer ASTX727 orally once daily for 5 days of each 21-day cycle.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for clinical benefit is measured at the end of 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04872543

A Study of ASTX727 in People With Malignant Peripheral Nerve Sheath Tumors (MPNST)

Recruiting
PHASE2Ages 16+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~25 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:ASTX727

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
the best clinical benefit rate (CBR)
Measured over at the end of 16 weeks

Conditions

Malignant Peripheral Nerve Sheath Tumors (MPNST)

Explore related trials

Malignant Peripheral Nerve Sheath TumorEED GeneHistone H3 Dimethyl Lys28Histone-Lysine N-Methyltransferase EZH2SUZ12 Gene

NCT04872543

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ping Chi, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Ping Chi, MD, PhD
[email protected]
646-888-4166
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Patients must have pathologically confirmed PRC2 loss MPNSTs (e.g. IHC of loss H3K27me2 and/or H3K27me3 immunostaining, and/or inactivating mutations in EED, SUZ12, EZH2 by CLIA approved genetic assays), which are advanced, unresectable or metastatic and have progressed on at least one line of standard of care systemic therapy, or administration of cytotoxic chemotherapy is not considered in the best interest for the patient.
Patients must be at least 16 years of age
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Disease must be measurable by RECIST 1.1.
Patients must be able to take oral medications.
Patient or legally authorized representative can understand and comply with the protocol and must sign an informed consent document.
Adequate renal, hepatic and hematologic function as the following: serum creatinine ≤ 1.5 x upper limit of normal (ULN), total serum bilirubin ≤ 1.5 x ULN, serum AST (SGOT) ≤ 2.5 x ULN (or ≤ 5.0 x ULN if considered due to tumor (liver metastases)), serum ALT (SGPT) ≤ 2.5 x ULN (or ≤ 5.0 x ULN if considered due to tumor (liver metastases)), ANC ≥ 1500/µL, platelets ≥ 75,000/µL, and hemoglobin ≥ 9 g/dL(can be transfused to achieve this). Prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time \> 1.5 x ULN. Patients on a stable maintenance regimen of anticoagulation therapy for at least 30 days prior to screening may have PT/INR measurements \> 1.5 x ULN
Patients of childbearing potential must have a negative serum pregnancy test at screening and at cycle 1 day 1 (-3 days) prior to the first dose of study therapy being administered. Female patients of childbearing potential must agree to use two reliable methods of contraception starting at signing the ICF, during and for 6 months following the last dose of study drug
Women must agree not to breastfeed during treatment with study drug and for 2 weeks after the last dose.
Sexually active males must agree to use a condom during intercourse and agree to not donate sperm while taking the drug and for 3 months after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men to prevent delivery of the drug via seminal fluid.

Exclusion

Patients have a severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
Patients have known active brain metastasis or leptomeningeal disease.
Active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immunodeficiency virus (HIV). Prior hepatitis infection that has been treated with highly effective therapy with no evidence of residual infection (including undetectable viral loads while on antiviral therapy) and with normal liver function (ALT, AST, total and direct bilirubin ≤ ULN) is allowed.
Known active tuberculosis.
Concurrent active inoperable locally advanced or metastatic malignancy (except for malignancies which the treating investigator determines are unlikely to interfere with treatment and safety analysis or are less of a treatment priority than their diagnosis of advanced MPNST).
Patients have clinically significant cardiovascular disease, including any of the following: 1) History of acute coronary syndrome including myocardial infarction, unstable angina, CABG, coronary angioplasty or stenting \< 6 months prior to screening; 2) symptomatic chronic heart failure (New York Heart Association Criteria, Class II-IV); 3) evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities \< 6 months prior to screening except atrial fibrillation (AF) and paroxysmal supraventricular tachycardia (PSVT).
A screening Fridericia corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women) (average of triplicates).
Left ventricular ejection fraction (LVEF) \<50% as determined by a multigated acquisition (MUGA) scan or echocardiogram.
History of thromboembolic or cerebrovascular events ≤ 3 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli.
Impairment of gastrointestinal function or gastrointestinal disease (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, ulcerative diseases, bowel resection with decreased intestinal absorption).
Patients had a major surgery within 3 weeks prior to study entry or who have not recovered from side effects of such procedure.
Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Treatment with anti-cancer therapy within 14 days prior to the first dose of study drug therapy. For prior biological therapies, e.g., monoclonal antibodies with a half-life longer than 3 days, the interval must be at least 28 days prior to the first dose of study drug.

What this trial measures

  • the best clinical benefit rate (CBR)at the end of 16 weeks

    (complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]) by RECIST1.1