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

NCT ID: NCT05570253

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2027-10-31

Brief Summary

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.

Detailed Description

The study includes a safety run-in period in which the first 15 patients enrolled will be assigned to receive the study drug SDX-7320 in combination with eribulin. Upon safety confirmation, randomization will commence for the subsequent 40 patients enrolled.

Conditions

Breast Cancer; Metastatic Triple-Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SDX-7320 plus Eribulin (safety run-in period)

During the safety run-in period, the first 15 patients enrolled will be assigned to received study drug SDX-7320 plus Eribulin. Not randomized.

Group Type: EXPERIMENTAL

Eribulin

Intervention Type: DRUG

Eribulin 1.4 mg/m2 IV on days 1 and 8 of an every 21 day cycle.

SDX-7320

Intervention Type: DRUG

SDX-7320 at the dose of 49 mg/m2 SC on a Q14D basis

SDX-7320 plus Eribulin

Patients randomized to SDX-7320 plus Eribulin.

Group Type: EXPERIMENTAL

Eribulin

Intervention Type: DRUG

Eribulin 1.4 mg/m2 IV on days 1 and 8 of an every 21 day cycle.

SDX-7320

Intervention Type: DRUG

SDX-7320 at the dose of 49 mg/m2 SC on a Q14D basis

Eribulin Plus Placebo

Patients randomized to the control arm will receive placebo plus Eribulin.

Group Type: PLACEBO_COMPARATOR

Eribulin

Intervention Type: DRUG

Eribulin 1.4 mg/m2 IV on days 1 and 8 of an every 21 day cycle.

Placebo

Intervention Type: OTHER

Placebo

Interventions

Eribulin

Eribulin 1.4 mg/m2 IV on days 1 and 8 of an every 21 day cycle.

Intervention Type: DRUG

SDX-7320

SDX-7320 at the dose of 49 mg/m2 SC on a Q14D basis

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SynDevRx, Inc.

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherry Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida, United States

Site Status: RECRUITING

Emory University (Data Collection Only)

Atlanta, Georgia, United States

Site Status: NOT_YET_RECRUITING

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status: RECRUITING

Hackensack Meridian Health

Hackensack, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sherry Shen, MD

Role: CONTACT

shens1@mskcc.org

646-888-5134

Tiffany Trainia, MD

Role: CONTACT

646-888-4558

Facility Contacts

Lauren Carcas, MD

Role: primary

954-837-1490

Neil Iyengar, MD

Role: primary

404-778-1900

Sherry Shen, MD

Role: primary

646-888-5134

Deena Graham, MD

Role: primary

551-996-5811

Sherry Shen, MD

Role: primary

646-888-5134

Sherry Shen, MD

Role: primary

646-888-5134

Sherry Shen, MD

Role: primary

646-888-5134

Sherry Shen, MD

Role: primary

646-888-5134

Sherry Shen, MD

Role: primary

646-888-5134

Tiffany Traina, MD

Role: backup

646-888-4558

Sherry Shen, MD

Role: primary

646-888-5134

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

22-074

Identifier Type: -

Identifier Source: org_study_id