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

NCT05570253 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-074
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 10

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.

Conditions

Breast Cancer; Metastatic Triple-Negative Breast Cancer

Keywords

Evexomostat (SDX-7320); Eribulin; 22-074

Outcome Measures

Primary Outcomes (1)

• change in insulin resistance scores (HOMA-IR)

  The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a validated tool for the assessment of insulin resistance.87 HOMA-IR is calculated as follows: fasting serum insulin (μU/mL) × fasting plasma glucose (mmol L -1 )/22.5).

  1 year

Secondary Outcomes (2)

• Type, frequency and severity of treatment-emergent adverse events

  2 years

• Overall response rate

  1 year

Study Arms (3)

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

EXPERIMENTAL

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

Drug: Eribulin; Drug: SDX-7320

SDX-7320 plus Eribulin

EXPERIMENTAL

Patients randomized to SDX-7320 plus Eribulin.

Drug: Eribulin; Drug: SDX-7320

Eribulin Plus Placebo

PLACEBO COMPARATOR

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

Drug: Eribulin; Other: Placebo

Interventions

Eribulin DRUG

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

Eribulin Plus Placebo; SDX-7320 plus Eribulin; SDX-7320 plus Eribulin (safety run-in period)

SDX-7320 DRUG

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

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

Placebo OTHER

Placebo

Eribulin Plus Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• SynDevRx, Inc.: collaborator

Study Sites (10)

BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida, 33143, United States

RECRUITING

Emory University (Data Collection Only)

Atlanta, Georgia, 30322, United States

RECRUITING

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sherry Shen, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherry Shen, MD

CONTACT

646-888-5134; shens1@mskcc.org

Tiffany Trainia, MD

CONTACT

646-888-4558

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multi-center, placebo-controlled phase 2 randomized control trial.

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: October 3, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (10)