A Phase 1 interventional study of SX-682 and Decitabine in Myelodysplastic Syndromes, sponsored by Syntrix Biosystems, Inc.. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Syntrix Biosystems, Inc. · Phase 1, Interventional, and Treatment
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).
Participants will receive twice daily oral SX-682 for six 28 day cycles. If patients are responding well to the treatment they can continue SX-682 treatment. The first participants will be administered 25 mg orally twice daily. Unless dose limiting toxicities occur, participants will enroll and receive the following increasing twice daily doses of SX-682: 50 mg, 100 mg, 200 mg, and 400 mg.
After establishing the maximum tolerated dose 140 additional participants will be enrolled at the recommended phase 2 dose. Participants will receive continuous SX-682 twice daily oral therapy in 28-day cycles for a total of 6 cycles. The expansion dose cohort will be stratified into IPSS (a) low and intermediate-1 (N=20 SX-682 alone in HMA naive, N=20 SX-682 alone in HMA failure, N=20 SX-682 + DEC-C in HMA-naïve, N=20 SX-682 + DEC-C in HMA-failure) and (b) intermediate-2 and high risk (N=20 SX-682 alone in HMA failure, N=20 SX-682 + DEC-C in HMA-naive, N=20 SX-682 + DEC-C in HMA-failure) MDS. For patients responding well at the end of 6 cycles treatment may continue until disease progression or an adverse event leads to SX-682 discontinuation. Except for blood product transfusions, concurrent therapy for Myelodysplastic Syndromes is not permitted.
2,124 studies on the registry are indexed under Myelodysplastic Syndromes; 320 are open to participants now.
This study's planned enrollment of 151 is above the median of 39 across 1,740 interventional studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →Syntrix Biosystems, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of MDS by World Health Organization criteria, and either
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").
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.
Screening laboratory values:
Exclusion Criteria:
Any of the following cardiac abnormalities:
Escalating oral doses of SX-682 (study drug) of 25, 50, 100, 200 and 400 mg twice-daily (i.e., 50, 100, 200, 400 and 800 mg total each day.
Drug: SX-682
Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in lower risk patients who have never received hypomethylating agents.
Drug: SX-682
Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in lower risk patients who failed on hypomethylating agents.
Drug: SX-682
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who have never received hypomethylating agents.
Drug: SX-682 · Drug: Decitabine
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who failed on hypomethylating agents.
Drug: SX-682 · Drug: Decitabine
Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in higher risk patients who failed on hypomethylating agents.
Drug: SX-682
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who have never received hypomethylating agents.
Drug: SX-682 · Drug: Decitabine
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who failed on hypomethylating agents.
Drug: SX-682 · Drug: Decitabine
SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
Decitabine is a hypomethylating agent.
Also known as: DEC-C
SX-682 Maximum Tolerated Dose (MTD)
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
Time frame: Up to 28 days in the 28 day Cycle 1.
SX-682 Dose Limiting Toxicities (DLT)
Number of participants experiencing DLTs.
Time frame: Up to 28 days in the 28 day Cycle 1.
Participants Experiencing a Treatment Response
The percentage of participants experiencing a complete remission, partial remission, or stable disease according to the International Working Group Response Criteria.
Time frame: At the end of Cycle 6 (each cycle is 28 days).
SX-682 Delayed Dose Limiting Toxicities
Number of delayed DLTs experienced by participants.
Time frame: From the beginning of Cycle 2 to the end of Cycle 6 (each cycle is 28 days).
Adverse Events
Number of participants experiencing adverse events (AEs).
Time frame: At the end of Cycle 6 (each cycle is 28 days).
SX-682 Single Dose Maximum Plasma Concentration (Cmax)
Blood samples will be collected before and after the first dose of SX-682 on Day 1 of Cycle 1.
Time frame: Day 1 of Cycle 1 (each cycle is 28 days).
SX-682 Steady-State Maximum Plasma Concentration (Css max)
Blood samples will be collected before and after the first dose of SX-682 on Day 15 of Cycle 1.
Time frame: Day 15 of Cycle 1 (each cycle is 28 days).
SX-682 Steady-State Minimum Plasma Concentration (Css min)
Blood samples will be collected before and after the first dose of SX-682 on Day 15 of Cycle 1.
Time frame: Day 15 of Cycle 1 (each cycle is 28 days).
Plan to share: No
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Syntrix Biosystems, Inc.