RecruitingPhase 2

A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer

"A Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests SDX-7320 plus the chemotherapy drug eribulin against eribulin alone. It is for adults with advanced triple-negative breast cancer and problems with blood sugar or obesity. Researchers will check how well the treatment works and what side effects it causes.

The researchers are doing this study to find out whether the study drug, SDX-7320, when combined with the standard chemotherapy eribulin, is an effective treatment for people with TNBC and metabolic dysfunction. The researchers will also look at whether the study treatment (SDX-7320 combined with eribulin) is safe and causes few or mild side effects in participants. The researchers will compare this treatment approach to eribulin alone.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, of any sex, and able to give written consent.
  • Have triple-negative breast cancer confirmed by lab tests. The cancer has spread or has come back nearby and cannot be cured with treatment or surgery.
  • Have had no more than 2 courses of treatment for advanced or spread cancer. Prior chemotherapy rules apply, with exceptions if certain drugs were not safe for you or the cancer had already spread when first found.
  • Have an HbA1c above 5.5% (a measure of average blood sugar), a body mass index (BMI) of 30 or higher, or both.
  • Have cancer that can be measured on scans, or at least one bone tumor that mainly breaks down bone and can be checked.
  • Be fully active or able to do light work. Blood tests must show that your blood cells and organs work well enough.
  • Be willing and able to follow study rules, including going without food before treatment days.
  • Follow the study's birth control rules: approved birth control for sexually active women who can become pregnant, and condoms for sexually active men.

Who can't join

  • Have had 3 or more courses of treatment for triple-negative breast cancer that has spread, or are taking part in another study of an experimental drug. Recent experimental treatment also requires a waiting period.
  • Have brain cancer, cancer that has spread to the brain, or an active brain or spinal cord condition.
  • Are pregnant or have a BMI below 18.5.
  • Have type 1 diabetes, type 2 diabetes that needs insulin or is not controlled, or use more than one blood sugar drug. Metformin alone is allowed if the dose has been stable for at least 3 months.
  • Have an allergy to either study drug, a past severe skin reaction to medicine, or use banned medicines or herbal products that cannot be stopped 7 days before treatment. Cannabis and CBD products are excepted from the herbal-product rule.
  • Have another cancer now or within the past 3 years, except certain treated skin or cervical cancers.
  • Have uncontrolled HIV, hepatitis B or C, or another severe or uncontrolled illness. Also excluded are long-term pancreas swelling or a sudden episode within the past year.
  • Have certain serious heart problems, recent heart events, high blood pressure that is not controlled, or abnormal heart rhythm tests. Some family histories of sudden death or inherited heart rhythm problems also exclude people.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Male or female with histologically and/or cytologically confirmed diagnosis of triple-negative metastatic breast cancer defined as estrogen and progesterone receptor staining ≤10%; and HER2-negative defined as IHC 0 to 1+ at enrolling institution (note: if IHC is equivocal, non-amplified status by FISH is acceptable) * Advanced (local regionally recurrent, not amenable to curative therapy or surgery) or metastatic stage with up to 2 prior lines of therapy in the advanced or metastatic setting * Received prior anthracycline and taxane chemotherapy in the neoadjuvant, adjuvant, or metastatic settings and considered appropriate for treatment with single agent eribulin OR was otherwise ineligible to receive anthracycline and/or taxane per treating physician OR patients with de novo metastatic disease. * Evidence of metabolic dysfunction defined as HbA1c \> 5.5 and/or BMI ≥ 30 kg/m\^2 * Measurable disease per the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), OR at least one evaluable, predominantly lytic bone lesion * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1. * Adult ≥18 at the time of informed consent and has provided written informed consent before the performance of any study-related activities and according to local guidelines. * Adequate bone marrow and organ function as defined by the following laboratory values (as assessed by local laboratory for eligibility): * Absolute neutrophil count (ANC) ≥ 1,000 µL * Platelet count ≥ 140,000 µL * Hemoglobin ≥9.0 g/dL: * Calcium (corrected for serum albumin) and magnesium ≤ Grade 1 according to National Cancer Institute (NCI) Common Terminology * Calculate Corrected Calcium if the albumin and/or serum calcium are not within normal limits: Corrected Calcium= Serum Calcium + 0.8 x \[(Normal Albumin) - Patient Albumin\] Normal Albumin value = 4.4g/dL Criteria for Adverse Events (CTCAE), version 5.0, and not considered by the Investigator to be clinically significant * Potassium within normal limits, with or without correction with supplements. * In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×the upper limit of normal (ULN). If the patient has liver metastases, ALT and AST ≤5×ULN. * Total bilirubin ≤1.5×ULN except for patient with Gilbert's syndrome who may only be included if the total bilirubin is ≤3.0×ULN or direct bilirubin ≤1.5×ULN * Creatinine ≤1.5 mg/dL. * Patient is, in the treating Investigator's opinion, willing and able to comply with the study requirements, including the ability to fast prior to treatment days. * If sexually active female of childbearing potential, willing to use a contraception method listed below: * Oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception * Oral, injectable, or implantable progesterone-only hormonal contraception * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomized partner with documentation of successful vasectomy. * Complete abstinence from heterosexual intercourse * If a sexually active male, willing to use barrier contraception (condoms) Exclusion Criteria: * Three or greater prior lines of therapy for metastatic TNBC * Known primary brain malignancy, brain metastases or active CNS pathology, any of which as determined by the treating Investigator * Currently participating in a study of an investigational agent * Body mass index \< 18.5 kg/m2 * Known hypersensitivity to SDX-7320 or eribulin * Established diagnosis of diabetes mellitus type I or uncontrolled or insulin-dependent type II. Uncontrolled is defined as fasting blood glucose \>140 mg/dL and/or HbA1c ≥8% * Use of combination antihyperglycemic therapy (single agent metformin on stable dose for at least 3 months prior to enrollment is allowable) * Concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, nonmelanomatous skin cancer or curatively resected cervical cancer. * Uncontrolled human immunodeficiency virus (HIV) infection. (Testing is not mandatory.) * Evidence of uncontrolled active Hepatitis B or C infection * History of Stevens-Johnson Syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), or other severe medication-related cutaneous reactions. * Any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical study (e.g., chronic active hepatitis, severe hepatic impairment). * Clinically significant, uncontrolled heart disease and/or recent cardiac events including any of the following: * History of angina pectoris, coronary artery bypass graft (CABG) symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry. * History of documented congestive heart failure (New York Heart Association functional classification III-IV). * Documented cardiomyopathy. * Left ventricular ejection fraction (LVEF) \<45%, as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO). * History of any cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle block, high grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months. * Uncontrolled hypertension, defined by a systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following: risk factors for torsades de pointe including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant/symptomatic bradycardia; concomitant medications with a known risk to prolong the QT interval and known to cause torsades de pointe that cannot be discontinued or replaced by safe alternative medications. * Bradycardia (heart rate less than 50 at rest), by electrocardiogram (ECG) or pulse. * Inability to determine the QT interval on the ECG (i.e., unreadable or not interpretable) or corrected QT (QTcF) \>450 msec for males and \>470 msec for females (using Fridericia's correction) during Screening, based on the mean of triplicate ECGs * Currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of the treatment: Medications with a known risk to prolong the QT interval or induce Torsade de Pointes (TdP). CredibleMeds list of drugs known to cause TdP may be used as a reference for this study to determine which drugs are prohibited using the following link: https://crediblemeds.org/new-drug-list or a crediblemeds mobile application. °Herbal preparations/medications, with the exception of cannabinoids, CBD compounds, etc. * Participation in a prior investigational study within 14 days prior to the start of the study treatment or within 5 half-lives of study drug, whichever is longer. * History of acute pancreatitis within 1 year of Screening or past medical history of chronic pancreatitis * Pregnant patients

Study sites (10)

FL

GA

NJ

NY