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

Overview

About this study

The purpose of this study is to 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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/16/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Hemant Murthy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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