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).
Diagnosis of MDS by World Health Organization criteria, and either
IPSS intermediate-2 risk or high risk patients: HMA failure or HMA naïve as defined above.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Renal glomerular filtration rate (GFR) ≥ 30 ml/min;
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.
QT interval > 480 msec corrected using Fridericia's formula;
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Treatment groupsSee each treatment group below.
Syntrix Biosystems, Inc.
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
AdventHealth
Collaborator
Emory University
Collaborator
University of Miami
Collaborator
Mayo Clinic
Collaborator
Montefiore Medical Center
Collaborator
National Cancer Institute (NCI)
Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborator