NCT05570253

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-03
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2022-10-06
• Last updated: 2026-04-17

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study