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Chemokine Receptor Antagonist

SX-682 + Decitabine for Myelodysplastic Syndrome

Phase 1

Recruiting

Led By David A Sallman, MD

Research Sponsored by Syntrix Biosystems, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

IPSS intermediate-2 risk or high risk and failed treatment following 4 cycles hypomethylating agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days in the 28 day cycle 1.

Awards & highlights

Study Summary

This trial will test the safety of a new drug, SX-682, in patients with Myelodysplastic Syndromes. The goal is to find the maximum tolerated dose and identify any dose-limiting toxicities.

Who is the study for?

This trial is for adults with Myelodysplastic Syndromes (MDS) who have not responded to previous treatments. Participants must have an acceptable level of kidney function, be in a relatively stable condition (ECOG ≤ 2), and not be pregnant or breastfeeding. They should also use contraception if applicable and cannot join if they've had certain heart issues, other cancers within the last 3 years, HIV, Hepatitis B/C, or are on specific medications.Check my eligibility

What is being tested?

The study is testing SX-682 alone and combined with Decitabine taken orally or intravenously to find the safest dose that can be tolerated without severe side effects. It aims to establish what's called the maximum tolerated dose (MTD) and recommend a Phase 2 dose for further studies.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site for IV drugs, fatigue, changes in blood counts leading to increased infection risk or bleeding problems. There could also be liver-related issues indicated by elevated enzymes AST/ALT and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My condition is high-risk and didn't improve after 4 treatments with a specific medication.

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My low or intermediate-1 risk cancer did not respond to specific treatments.

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My condition is low or intermediate-1 risk with 5q deletion, and treatments with lenalidomide did not work for me.

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I am a man and will use the specified contraception if sexually active.

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My kidney function, measured by GFR, is at least 30 ml/min.

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I have been diagnosed with MDS according to WHO standards.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days in the 28 day cycle 1.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days in the 28 day cycle 1.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days in the 28 day cycle 1. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

SX-682 Dose Limiting Toxicities (DLT)

SX-682 Maximum Tolerated Dose (MTD)

Secondary outcome measures

Adverse Events

Participants Experiencing a Treatment Response

SX-682 Delayed Dose Limiting Toxicities

+3 more

Side effects data

From 2022 Phase 2 trial • 14 Patients • NCT04055844

57%

Febrile neutropenia

57%

Neutrophil count decreased

21%

Infections and infestations - Other, specify

21%

Lung infection

21%

Bacteremia

21%

Sepsis

14%

Aspartate aminotransferase increased

14%

Alanine aminotransferase increased

14%

Infections and infestations - Other,

Mucositis oral

White blood cell decreased

Syncope

Upper gastrointestinal

Sinusitis

Hyperglycemia

Hypertension

Encephalopathy

Hepatobiliary disorders

Blood and lymphatic system

General disorders and administration

INR increased

Typhlitis

Upper gastrointestinal hemorrhage

Hepatic failure

Injury, poisoning and procedural

Blood and lymphatic system disorders - Other, specify

Fatigue

Intracranial hemorrhage

Gastrointestinal disorders - Other,

Disease progression

Fever

Skin and subcutaneous tissue disorders - Other, specify

Neoplasms benign, malignant and

Alanine aminotransferase

Tooth infection

Gastrointestinal disorders - Other, specify

Pericardial effusion

General disorders and administration site conditions - Other, specify

Hepatic infection

100%

80%

60%

40%

20%

Study treatment Arm

Decitabine + Ruxolitinib + DLI

Trial Design

8Treatment groups

Experimental Treatment

Group I: Expansion of SX-682 with decitabine (lower risk patients, naive to hypomethylating agents)Experimental Treatment2 Interventions

Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) with decitabine in lower risk patients who have never received hypomethylating agents.

Group II: Expansion of SX-682 with decitabine (lower risk patients, failed on hypomethylating agents)Experimental Treatment2 Interventions

Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) with decitabine in lower risk patients who failed on hypomethylating agents.

Group III: Expansion of SX-682 with decitabine (higher risk patients, naive to hypomethylating agents)Experimental Treatment2 Interventions

Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) with decitabine in higher risk patients who have never received hypomethylating agents.

Group IV: Expansion of SX-682 with decitabine (higher risk patients, failed on hypomethylating agents)Experimental Treatment2 Interventions

Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) with decitabine in higher risk patients who failed on hypomethylating agents.

Group V: Expansion of SX-682 alone (lower risk patients, naive to hypomethylating agents)Experimental Treatment1 Intervention

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.

Group VI: Expansion of SX-682 alone (lower risk patients, failed on hypomethylating agents)Experimental Treatment1 Intervention

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.

Group VII: Expansion of SX-682 alone (higher risk patients, failed on hypomethylating agents)Experimental Treatment1 Intervention

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.

Group VIII: Dose Escalation of SX-682Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2004

Completed Phase 3

~1680

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Syntrix Biosystems, Inc.Lead Sponsor

13 Previous Clinical Trials

656 Total Patients Enrolled

Emory UniversityOTHER

1,640 Previous Clinical Trials

2,560,545 Total Patients Enrolled

University of MiamiOTHER

902 Previous Clinical Trials

409,925 Total Patients Enrolled

Media Library

SX-682 (Chemokine Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04245397 — Phase 1

Myelodysplastic Syndrome Research Study Groups: Expansion of SX-682 with decitabine (higher risk patients, failed on hypomethylating agents), Expansion of SX-682 alone (lower risk patients, naive to hypomethylating agents), Expansion of SX-682 with decitabine (higher risk patients, naive to hypomethylating agents), Dose Escalation of SX-682, Expansion of SX-682 alone (lower risk patients, failed on hypomethylating agents), Expansion of SX-682 with decitabine (lower risk patients, naive to hypomethylating agents), Expansion of SX-682 with decitabine (lower risk patients, failed on hypomethylating agents), Expansion of SX-682 alone (higher risk patients, failed on hypomethylating agents)

Myelodysplastic Syndrome Clinical Trial 2023: SX-682 Highlights & Side Effects. Trial Name: NCT04245397 — Phase 1

SX-682 (Chemokine Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04245397 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key outcomes this trial is attempting to produce?

"The primary purpose of this trial is to identify the Maximum Tolerated Dose (MTD) for SX-682. Secondary objectives include assessing Single Dose Maximum Plasma Concentration (Cmax), Steady-State Maximum Plasma Concentration (Css max), and Steady-State Minimum Plasma Concentration (Css min). Blood samples will be taken during Day 1 and 15 of Cycle 1, with outcomes evaluated over a 28 day period."

Answered by AI

Is this study actively seeking volunteers?

"Affirmative. Clinicaltrials.gov supports that this trial is recruiting participants, which was first posted on the 12th of May 2020 and revised most recently on 18th February 2022. This study seeks to enrol 64 patients across 3 separate sites."

Answered by AI

How many volunteers are involved in this experiment?

"Affirmative. Information found on clinicaltrials.gov suggests that the study is enrolling patients, with its initial posting being on May 12th 2020 and last updated February 18th 2022. Sixty-four subjects from 3 medical centres are anticipated for enrollment in this trial."

Answered by AI

Could you please elucidate the risks associated with SX-682?

"Our team at Power rated SX-682's safety as a 1 on our scale, considering that this is an early phase trial and there are only preliminary data supporting its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04245397.

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