Treatment of Myelodysplastic Syndrome with SX-682 and Decitabine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of SX-682, an immunotherapy agent, both alone and in combination with decitabine, for patients with Myelodysplastic Syndromes (MDS). Participants will receive SX-682 orally twice daily over six 28-day cycles, with dose adjustments based on tolerability and response. The study aims to establish the maximum tolerated dose and recommended phase 2 dose, enrolling additional participants based on their treatment history and risk classification. The trial will also assess the impact of SX-682 on myeloid-derived suppressor cells and overall patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of MDS by World Health Organization criteria, and either

  1. International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk patients without 5q deletion:

     i. Dose escalation portion: failed prior treatment with at least 4 cycles started of a hypomethylating agent (HMA; azacitidine or decitabine) defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy.

     ii. Dose expansion portion: failed prior treatment defined as no response to treatment with at least 4 cycles started of HMA, loss of response at any time point, or progressive disease/intolerance to therapy ("HMA failure"); or no prior treatment with HMA ("HMA naive").
  2. IPSS low risk or intermediate-1 risk patients with 5q deletion:

     i. Dose escalation portion: failed prior treatment with at least 4 cycles started of lenalidomide and 4 cycles of hypomethylating agent (azacitidine or decitabine) defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy.

     ii. Dose expansion portion: same as non-del(5q) lower risk cohort + requirement of failed prior treatment with lenalidomide defined as no response to treatment with at least 4 cycles started of lenalidomide, loss of response at any time point, or progressive disease/intolerance to therapy.
  3. IPSS intermediate-2 risk or high risk patients: HMA failure or HMA naïve as defined above.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
* Screening laboratory values:

  1. Renal glomerular filtration rate (GFR) ≥ 30 ml/min;
  2. Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 3.0 times upper limit of normal;
  3. Bilirubin \< 1.5 times upper limit of normal;
  4. No history of HIV being HIV positive;
  5. No active Hepatitis B or Hepatitis C infection.
* Life expectancy ≥ 12 weeks.
* Women of childbearing potential (WOCBP) must use study specified contraception.
* WOCBP demonstrate negative pregnancy test.
* Not breastfeeding.
* Men sexually active must use study specified contraception.

Exclusion Criteria:

* Use of chemotherapeutic agents or experimental agents for MDS within 14 days of the first day of study drug treatment.
* Use of erythroid stimulating agents, Granulocyte-colony stimulating factor (G-CSF), or Granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days of the first day of study drug treatment, or during the study.
* Mean triplicate heart rate-corrected QT interval (QTc) \> 500 msec.
* Any of the following cardiac abnormalities:

  1. QT interval \> 480 msec corrected using Fridericia's formula;
  2. Risk factors for Torsade de Pointes;
  3. Use of medication that prolongs the QT interval with the exception of drugs that are considered absolutely essential for the care of the subject;
  4. Myocardial infarction ≤ 6 months prior to first day of study drug treatment;
  5. Unstable angina pectoris or serious uncontrolled cardiac arrhythmia.
* Any serious or uncontrolled medical disorder.
* Prior malignancy within the previous 2 years except for local cancers that have been cured; or patients who have been adequately treated and have low risk of reoccurrence.
* Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* Use of other investigational drugs within 30 days of study drug administration.
* Major surgery within 4 weeks of study drug administration.
* Live-virus vaccination within 30 days of study drug administration.
* Allergy to study drug component.

Where it's running

• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• AdventHealth Medical Group & Bone Marrow Transplant at Orlando
  Orlando, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: David A Sallman, MD — Moffitt Cancer Center
• Study coordinator: Aaron D Schuler, PhD
• Email: aschuler@syntrixbio.com
• Phone: 253-833-8009

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.