Study on SDX-7320 and Eribulin Combination for Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05570253

Provider View

This clinical trial is exploring whether a new drug, SDX-7320, combined with the chemotherapy drug eribulin, is effective and safe for treating people with triple-negative breast cancer (TNBC) and metabolic issues. The study will compare this combination to eribulin alone.

Patient Parameters

Program Overview

The purpose of this study is to determine if the combination of SDX-7320 and eribulin can effectively treat triple-negative breast cancer (TNBC) in patients who also have metabolic dysfunction. Researchers will also assess the safety of this treatment and monitor for any side effects. The study will compare the results of this combination treatment to using eribulin alone.

Description

The study begins with a safety phase where the first 15 participants will receive the combination of SDX-7320 and eribulin to ensure it is safe. Once safety is confirmed, the next 40 participants will be randomly assigned to receive either the combination treatment or eribulin alone.

Eligibility Criteria

Inclusion Criteria

  • Men or women diagnosed with triple-negative metastatic breast cancer, which means the cancer does not have estrogen, progesterone, or HER2 receptors.
  • Cancer that has spread or returned and cannot be cured with surgery, with up to two previous treatments for advanced cancer.
  • Previously treated with anthracycline and taxane chemotherapy and suitable for eribulin treatment.
  • Have metabolic dysfunction, shown by a blood sugar level (HbA1c) over 5.5 or a body mass index (BMI) of 30 or higher.
  • Have measurable cancer or at least one bone lesion that can be evaluated.
  • Be in good general health with an ECOG performance status of 0 or 1.
  • Be 18 years or older and able to provide written consent.
  • Have adequate blood and organ function based on specific lab tests.
  • Be willing to follow study requirements, including fasting before treatment.
  • Women of childbearing potential must agree to use effective birth control methods.
  • Men must agree to use condoms if sexually active.

Exclusion Criteria

  • Have had three or more previous treatments for metastatic TNBC.
  • Have brain cancer, brain metastases, or active central nervous system issues.
  • Currently participating in another investigational study.
  • Have a BMI less than 18.5.
  • Have allergies to SDX-7320 or eribulin.
  • Have uncontrolled diabetes or require insulin for diabetes management.
  • Use multiple diabetes medications (except stable single-agent metformin).
  • Have severe liver disease (Child Pugh score B or C).
  • Have another cancer within the last three years, except for certain skin or cervical cancers.
  • Have uncontrolled HIV, Hepatitis B, or C infections.
  • Have a history of severe skin reactions to medications.
  • Have any severe or uncontrolled medical conditions that could interfere with the study.
  • Have significant heart disease or recent heart events.
  • Have uncontrolled high blood pressure.
  • Have a history of long QT syndrome or other heart rhythm issues.
  • Currently taking medications that affect heart rhythm and cannot stop them before the study.
  • Have participated in another investigational study recently.
  • Have a history of pancreatitis within the last year.
  • Are pregnant.

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