Actively Recruiting
A Study of ASTX727 in People With Malignant Peripheral Nerve Sheath Tumors (MPNST)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-05
25
Participants Needed
7
Research Sites
309 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
T
Taiho Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to see whether the study drug ASTX727 is an effective treatment for people who have MPNST with a PCR2 mutation. ASTX727 is a combination of two drugs (cedazuridine and decitabine) that have been designed to target cancer cells with a PCR2 mutation and to disrupt the cells' ability to survive and grow. The study researchers think that the study drug allows decitabine to work better than decitabine given alone.
CONDITIONS
Official Title
A Study of ASTX727 in People With Malignant Peripheral Nerve Sheath Tumors (MPNST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have pathologically confirmed PRC2 loss MPNSTs that are advanced, unresectable, or metastatic and have progressed on at least one line of standard systemic therapy or are not suitable for cytotoxic chemotherapy
- Patients must be at least 16 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Disease must be measurable by RECIST 1.1 criteria
- Patients must be able to take oral medications
- Patient or legally authorized representative must understand and agree to comply with the protocol and sign informed consent
- Adequate kidney, liver, and blood function with specified laboratory values within limits
- Negative serum pregnancy test for women of childbearing potential at screening and before first dose
- Female patients of childbearing potential must use two reliable contraception methods from consent signing through 6 months after last dose
- Women must not breastfeed during treatment and for 2 weeks after last dose
- Sexually active males must use condoms during intercourse and avoid sperm donation during treatment and for 3 months after stopping treatment
You will not qualify if you...
- Severe or uncontrolled medical diseases such as uncontrolled diabetes, chronic kidney disease, or active infections
- Active brain metastases or leptomeningeal disease
- Active or chronic infection with hepatitis B, hepatitis C, or HIV (except treated hepatitis with no residual infection and normal liver function)
- Known active tuberculosis
- Concurrent active inoperable advanced or metastatic cancers that interfere with treatment or safety
- Significant heart diseases including recent acute coronary syndrome, symptomatic heart failure (Class II-IV), clinically significant arrhythmias except certain types
- Prolonged corrected QT interval (QTcF ≥450 ms in men or ≥470 ms in women)
- Left ventricular ejection fraction below 50%
- Recent thromboembolic or cerebrovascular events within 3 months
- Gastrointestinal conditions impairing function such as uncontrolled nausea, vomiting, diarrhea, malabsorption, or ulcerative diseases
- Major surgery within 3 weeks prior to study or not recovered from surgery side effects
- History of non-compliance to medical regimens or inability to give reliable consent
- Anti-cancer therapy within 14 days prior to first dose (28 days for some biological therapies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
P
Ping Chi, MD, PhD
CONTACT
C
Ciara Kelly, MBBCH BAO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here