Actively Recruiting
A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-27
55
Participants Needed
10
Research Sites
260 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
S
SynDevRx, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female with confirmed triple-negative metastatic breast cancer
- Advanced or metastatic stage with up to 2 prior therapy lines for advanced disease
- Prior anthracycline and taxane chemotherapy received or ineligible for these treatments
- Metabolic dysfunction evidenced by HbA1c > 5.5 and/or BMI 2 30 kg/m2
- Measurable disease per RECIST 1.1 or evaluable lytic bone lesion
- ECOG Performance Status 1
- Adults aged 18 or older who have provided informed consent
- Adequate bone marrow and organ function based on specified lab criteria
- Willing and able to comply with study requirements
- If female and sexually active, willing to use approved contraception methods
- If male and sexually active, willing to use barrier contraception
You will not qualify if you...
- Three or more prior therapy lines for metastatic TNBC
- Known brain malignancy, brain metastases, or active CNS pathology
- Currently enrolled in another investigational study
- Body mass index less than 18.5 kg/m2
- Known hypersensitivity to SDX-7320 or eribulin
- Diagnosed diabetes type I or uncontrolled/insulin-dependent type II diabetes
- Use of combination antihyperglycemic therapy (except stable metformin)
- Other active or recent malignancies within 3 years except certain skin or cervical cancers
- Uncontrolled HIV infection
- Active uncontrolled Hepatitis B or C infection
- History of severe medication-related skin reactions
- Severe or uncontrolled medical conditions contraindicating participation
- Significant uncontrolled heart disease or recent cardiac events
- Currently using medications that prolong QT interval and cannot be stopped
- Participation in investigational study within 14 days or 5 half-lives of study drug
- History of acute or chronic pancreatitis within past year
- Pregnant patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, United States, 33143
Actively Recruiting
2
Emory University (Data Collection Only)
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
Actively Recruiting
5
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
6
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
7
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
8
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
9
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
10
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
S
Sherry Shen, MD
CONTACT
T
Tiffany Trainia, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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