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Myelodysplastic SyndromesPhase 1NCT04245397

Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome

A Phase 1 study testing SX-682 and Decitabine in people with Myelodysplastic Syndromes, run by Syntrix Biosystems, Inc. at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
SX-682 and Decitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
7 sitesUnited States
Study dates
30 Jun 2020to Mar 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
  • 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:
  • 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.
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  • 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.
  • 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:
  • Renal glomerular filtration rate (GFR) ≥ 30 ml/min;
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 3.0 times upper limit of normal;
  • Bilirubin < 1.5 times upper limit of normal;
  • No history of HIV being HIV positive;
  • 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.

Who cannot join

  • 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:
  • QT interval > 480 msec corrected using Fridericia's formula;
  • Risk factors for Torsade de Pointes;
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  • Use of medication that prolongs the QT interval with the exception of drugs that are considered absolutely essential for the care of the subject;
  • Myocardial infarction ≤ 6 months prior to first day of study drug treatment;
  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aaron D Schuler, PhD contact

253-833-8009 ext. 21

aschuler@syntrixbio.com

7 sites in 1 country

United States7 sites, 7 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Danielle Alexander, MS, 404-778-3663, danielle.oliver@emory.edu

    Anthony M Hunter, MD

    Recruiting

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

    Lisa A. Kelemen, RN, MSN, 410-614-4618, lkeleme1@jhmi.edu

    Amy E DeZern, MD, MHS

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    David Hodges, EMT, 904-953-5200, Hodges.David@mayo.edu

    Hemant S Murthy, MD

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Namrata S Chandhok, MD, 305-243-8238, namrata.chandhok@miami.edu

    Namrata S Chandhok, MD

    Recruiting

  • AdventHealth Medical Group & Bone Marrow Transplant at Orlando

    Orlando, Florida, 32804

    Kristen Wing, RN,BSN,CCRP, 407-303-8251, Kristen.Wing@adventhealth.com

    Arlene Gayle, M.D.

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Charlie Riesebeck, 813-745-3884, Charlie.Riesebeck@moffitt.org

    Cyril Patra, MPH, 813-745-2802, Cyril.Patra@moffitt.org

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Mendel Goldfinger, MD, clinicaltrials@syntrixbio.com

    Anne Munoz, RN, 718-920-2006, anmunoz@montefiore.org

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Dose-Escalation With Expansion Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome

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).

Read the detailed description

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.

Being tested
SX-682, Decitabine
Keywords
Immunotherapy, Chemokine receptor blockade, Myeloid-derived supressor cells
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SX-682Drug

    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)

  • DecitabineDrug

    Also called DEC-C

    Decitabine is a hypomethylating agent.

Study groups in NCT04245397
Study groupRoleWhat they receive
Dose Escalation of SX-682ExperimentalEscalating 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.
Receives: Drug: SX-682
Expansion of SX-682 alone (lower risk patients, naive to hypomethylating agents)ExperimentalExpansion 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.
Receives: Drug: SX-682
Expansion of SX-682 alone (lower risk patients, failed on hypomethylating agents)ExperimentalExpansion 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.
Receives: Drug: SX-682
Expansion of SX-682 with decitabine (lower risk patients, naive to hypomethylating agents)ExperimentalExpansion 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.
Receives: Drug: SX-682; Drug: Decitabine
Expansion of SX-682 with decitabine (lower risk patients, failed on hypomethylating agents)ExperimentalExpansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who failed on hypomethylating agents.
Receives: Drug: SX-682; Drug: Decitabine
Expansion of SX-682 alone (higher risk patients, failed on hypomethylating agents)ExperimentalExpansion 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.
Receives: Drug: SX-682
Expansion of SX-682 with decitabine (higher risk patients, naive to hypomethylating agents)ExperimentalExpansion 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.
Receives: Drug: SX-682; Drug: Decitabine
Expansion of SX-682 with decitabine (higher risk patients, failed on hypomethylating agents)ExperimentalExpansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who failed on hypomethylating agents.
Receives: Drug: SX-682; Drug: Decitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 28 days in the 28 day Cycle 1.

  2. SX-682 Dose Limiting Toxicities (DLT)

    Number of participants experiencing DLTs.

    Measured: Up to 28 days in the 28 day Cycle 1.

Secondary outcomes (6)

  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.

    Measured: At the end of Cycle 6 (each cycle is 28 days).

  2. SX-682 Delayed Dose Limiting Toxicities

    Number of delayed DLTs experienced by participants.

    Measured: From the beginning of Cycle 2 to the end of Cycle 6 (each cycle is 28 days).

  3. Adverse Events

    Number of participants experiencing adverse events (AEs).

    Measured: At the end of Cycle 6 (each cycle is 28 days).

  4. 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.

    Measured: Day 1 of Cycle 1 (each cycle is 28 days).

  5. 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.

    Measured: Day 15 of Cycle 1 (each cycle is 28 days).

  6. 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.

    Measured: Day 15 of Cycle 1 (each cycle is 28 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2020
  2. Study start30 Jun 2020
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
In this sequential model initially participant groups will enroll to receive SX-682 for six 28 day cycles in a dose escalation phase. A 3 + 3 participant design will be used to determine the safe dose. After 6 cycles at the specified dose of SX-682, SX-682 treatment can be continued. Once the safe dose level of SX-682 is determined, then participants will be enrolled at the this safe dose level of SX-682 in an expansion phase.
Masking
None (open label)
Enrolment
151 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04245397
Sponsor's protocol ID
SX682-MDS-102
Other IDs
R44HL142389, R44CA291622
Status last verified
Dec 2025
First submitted
22 Jan 2020
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SX-682 and Decitabine in people with Myelodysplastic Syndromes, run by Syntrix Biosystems, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aaron D Schuler, PhD (253-833-8009 ext. 21, aschuler@syntrixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SX-682 Maximum Tolerated Dose (MTD) (time frame: Up to 28 days in the 28 day Cycle 1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04245397.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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