A Phase 1, Open-Label, Dose-Escalation With Expansion Study of SX-682 in Subjects With Myelodysplastic Syndrome Who Had Disease Progression or Are Intolerant to Prior Therapy

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

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

1. International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk without 5q deletion and failed treatment (no response, loss of response, progressive disease/treatment intolerance) following:

i. 4 cycles hypomethylating agent; or ii. 4 cycles hypomethylating agent, or lenalidomide or erythropoietin stimulating agent (ESA).
2. IPSS low risk or intermediate-1 risk with 5q deletion and failed treatment following:

i. 4 cycles of lenalidomide and hypomethylating agent; or ii. 4 cycles of lenalidomide.
3. IPSS intermediate-2 risk or high risk and failed treatment following 4 cycles hypomethylating agent.
* 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;
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 3 years except for local cancers that have been cured.
* 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.

Additional Trial Information

Phase 1

Enrollment: 64 patients (estimated)

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Trial Locations

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Sylvester Comprehensive Cancer Center University of Miami Health System

Miami, FL

Open and Accepting

AdventHealth (East Orlando)

Orlando, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting


Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting
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