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Study of SX-682 for Myelodysplastic Syndromes

This study is testing a new oral drug called SX-682, alone or with decitabine, for people with Myelodysplastic Syndromes (MDS). SX-682 works by blocking certain signals (CXCR1 and CXCR2) that may play a role in MDS. The main goal is to find the safest and most effective dose of SX-682. You might be able to join if you have MDS and have either not responded to or have not yet received treatment with a similar drug called a hypomethylating agent (HMA). The study will look at how safe the drug is and what side effects it might cause. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 151 participants. It will first determine the maximum tolerated dose of SX-682, then enroll more participants at that dose.
What's involved
Participants will take SX-682 by mouth twice daily for at least six 28-day cycles. If you respond well, you may continue treatment until your disease progresses or side effects occur.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for safety and side effects during the first 28-day cycle to determine the maximum tolerated dose and dose-limiting toxicities.

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

NCT04245397

Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome

Recruiting
PHASE1Ages 18+InterventionalTreatment
Syntrix Biosystems, Inc.
~151 participants
Updated 2025-12-23 on ClinicalTrials.gov
What's tested:SX-682Decitabine

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
SX-682 Maximum Tolerated Dose (MTD)
Measured over Up to 28 days in the 28 day Cycle 1.
+1 more outcome measured

Conditions

Myelodysplastic Syndromes

Explore related trials

Myelodysplastic SyndromeLoss of Chromosome 5q

Where it's being run

7 sites across 4 states
Florida4
Georgia1
Maryland1
New York1

Study leadership

  • David A Sallman, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Aaron D Schuler, PhD
[email protected]
253-833-8009 · ext. 21
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of MDS by World Health Organization criteria, and either
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Screening laboratory values:
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

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:
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.

What this trial measures

  • SX-682 Maximum Tolerated Dose (MTD)Up to 28 days in the 28 day Cycle 1.

    Participants cohorts will be enrolled at increasing doses of SX-682. The highest SX-682 dose tested at which no more than 1 of 6 participants experiences a dose limiting toxicity will define the SX-682 MTD

  • SX-682 Dose Limiting Toxicities (DLT)Up to 28 days in the 28 day Cycle 1.

    Number of participants experiencing DLTs.