SX-682 Treatment in Subjects With Myelodysplastic Syndrome Who Had Disease Progression or Are Intolerant to Prior Therapy

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Syntrix Biosystems, Inc.
• Collaborators: H. Lee Moffitt Cancer Center and Research Institute; National Heart, Lung, and Blood Institute (NHLBI)

Criteria

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) ≥ 60 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.

• Within 14 days of the first study drug treatment requiring systemic treatment with either corticosteroids or immunosuppressive medications. Corticosteroid adrenal replacement doses are permitted.

• 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.