NCT04245397 Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
| NCT ID | NCT04245397 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Syntrix Biosystems, Inc. |
| Condition | Myelodysplastic Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 151 participants |
| Start Date | 2020-06-30 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 151 participants in total. It began in 2020-06-30 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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 patients without 5q deletion: i. Dose escalation portion: failed prior treatment with at least 4 cycles started of a hypomethylating agent (HMA; azacitidine or decitabine) defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy. ii. Dose expansion portion: failed prior treatment defined as no response to treatment with at least 4 cycles started of HMA, loss of response at any time point, or progressive disease/intolerance to therapy ("HMA failure"); or no prior treatment with HMA ("HMA naive"). 2. IPSS low risk or intermediate-1 risk patients with 5q deletion: i. Dose escalation portion: failed prior treatment with at least 4 cycles started of lenalidomide and 4 cycles of hypomethylating agent (azacitidine or decitabine) defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy. ii. Dose expansion portion: same as non-del(5q) lower risk cohort + requirement of failed prior treatment with lenalidomide defined as no response to treatment with at least 4 cycles started of lenalidomide, loss of response at any time point, or progressive disease/intolerance to therapy. 3. IPSS intermediate-2 risk or high risk patients: HMA failure or HMA naïve as defined above. * 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 with the exception of drugs that are considered absolutely essential for the care of the subject; 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 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.
Contact & Investigator
David A Sallman, MD
PRINCIPAL INVESTIGATOR
Moffitt Cancer Center
Frequently Asked Questions
Who can join the NCT04245397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelodysplastic Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04245397 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04245397 currently recruiting?
Yes, NCT04245397 is actively recruiting participants. Contact the research team at aschuler@syntrixbio.com for enrollment information.
Where is the NCT04245397 trial being conducted?
This trial is being conducted at Jacksonville, United States, Miami, United States, Orlando, United States, Tampa, United States and 3 additional locations.
Who is sponsoring the NCT04245397 clinical trial?
NCT04245397 is sponsored by Syntrix Biosystems, Inc.. The principal investigator is David A Sallman, MD at Moffitt Cancer Center. The trial plans to enroll 151 participants.