A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer
NCT05570253 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2026-04-27
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
Interventions
- DRUG
-
Eribulin
Eribulin 1.4 mg/m2 IV on days 1 and 8 of an every 21 day cycle.
- DRUG
-
SDX-7320
SDX-7320 at the dose of 49 mg/m2 SC on a Q14D basis
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
SynDevRx, Inc.
collaborator INDUSTRY -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Sherry Shen, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-03
- Primary Completion
- 2027-10-31
- Completion
- 2027-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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