Actively Recruiting
Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
Led by Syntrix Biosystems, Inc. · Updated on 2025-12-23
151
Participants Needed
7
Research Sites
452 weeks
Total Duration
On this page
Sponsors
S
Syntrix Biosystems, Inc.
Lead Sponsor
H
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
CONDITIONS
Official Title
Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of MDS by World Health Organization criteria
- IPSS low or intermediate-1 risk without 5q deletion with prior hypomethylating agent failure or naive status as defined
- IPSS low or intermediate-1 risk with 5q deletion with prior lenalidomide and hypomethylating agent failure or naive status as defined
- IPSS intermediate-2 or high risk with hypomethylating agent failure or naive status
- ECOG Performance Status of 2 or less
- Renal glomerular filtration rate of at least 30 ml/min
- AST/ALT liver enzymes not exceeding 3 times the upper normal limit
- Bilirubin level less than 1.5 times the upper normal limit
- Not positive for HIV
- No active Hepatitis B or C infection
- Life expectancy of at least 12 weeks
- Women of childbearing potential must use study specified contraception and have a negative pregnancy test
- Not breastfeeding
- Men who are sexually active must use study specified contraception
You will not qualify if you...
- Use of chemotherapy or experimental agents for MDS within 14 days before starting study drug
- Use of erythroid stimulating agents, G-CSF, or GM-CSF within 14 days before or during the study
- QTc interval greater than 500 msec
- Cardiac abnormalities including QT interval over 480 msec, risk factors for Torsade de Pointes, or use of QT-prolonging medications except essential drugs
- Myocardial infarction within 6 months before study drug
- Unstable angina or serious uncontrolled arrhythmia
- Any serious or uncontrolled medical disorder
- Prior malignancy within 2 years except cured local cancers with low recurrence risk
- Need for systemic corticosteroids over 10 mg prednisone equivalents or other immunosuppressives within 14 days before study drug
- Use of other investigational drugs within 30 days before study drug
- Major surgery within 4 weeks before study drug
- Live-virus vaccination within 30 days before study drug
- Allergy to study drug components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
AdventHealth Medical Group & Bone Marrow Transplant at Orlando
Orlando, Florida, United States, 32804
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
7
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
A
Aaron D Schuler, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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