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

NCT04245397 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2025-12-23

No results posted yet for this study

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).

Conditions

Interventions

DRUG

SX-682

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)

DRUG

Decitabine

Decitabine is a hypomethylating agent.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • AdventHealth

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • University of Miami

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • Montefiore Medical Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    collaborator OTHER

  • Syntrix Biosystems, Inc.

    lead INDUSTRY

Principal Investigators

  • David A Sallman, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2028-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04245397 on ClinicalTrials.gov