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

ConditionMyelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSyntrix Biosystems, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of MDS by World Health Organization criteria, and either

IPSS intermediate-2 risk or high risk patients: HMA failure or HMA naïve as defined above.

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

Renal glomerular filtration rate (GFR) ≥ 30 ml/min;

Disqualifiers

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.

QT interval > 480 msec corrected using Fridericia's formula;

Trial design

Design model

Sequential

Treatments tested in this trial

  • SX-682

    Drug

    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

    Drug

    Decitabine is a hypomethylating agent.

Treatment groups

151 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Dose Escalation of SX-682Experimental treatment 1 intervention
Group B: Expansion of SX-682 alone (lower risk patients, naive to hypomethylating agents)Experimental treatment 1 intervention
Group C: Expansion of SX-682 alone (lower risk patients, failed on hypomethylating agents)Experimental treatment 1 intervention
Group D: Expansion of SX-682 with decitabine (lower risk patients, naive to hypomethylating agents)Experimental treatment 2 interventions
Group E: Expansion of SX-682 with decitabine (lower risk patients, failed on hypomethylating agents)Experimental treatment 2 interventions
Group F: Expansion of SX-682 alone (higher risk patients, failed on hypomethylating agents)Experimental treatment 1 intervention
Group G: Expansion of SX-682 with decitabine (higher risk patients, naive to hypomethylating agents)Experimental treatment 2 interventions
Group H: Expansion of SX-682 with decitabine (higher risk patients, failed on hypomethylating agents)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Time frame
Up to 28 days in the 28 day Cycle 1.
2

SX-682 Dose Limiting Toxicities (DLT)

Number of participants experiencing DLTs.

Time frame
Up to 28 days in the 28 day Cycle 1.

Secondary outcomes

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).
2

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).
3

Adverse Events

Number of participants experiencing adverse events (AEs).

Time frame
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.

Time frame
Day 1 of Cycle 1 (each cycle is 28 days).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Syntrix Biosystems, Inc.

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

AdventHealth

Collaborator

Emory University

Collaborator

University of Miami

Collaborator

Mayo Clinic

Collaborator

Montefiore Medical Center

Collaborator

National Cancer Institute (NCI)

Collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborator

Source ClinicalTrials.gov
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