Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer
Recruiting now · Phase 1/Phase 2
Conditions studied: HR+/HER2-negative Breast Cancer, Metastatic Breast Cancer
In brief
This is a Phase 1b/2, open-label, parallel-arms pilot study in men and post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or AKT1 mutation, designed to determine the safety of evexomostat (SDX-7320) plus standard of care treatment alpelisib (BYL-719) or capivasertib and fulvestrant (each combined, the 'triplet therapy'), to measure the severity and number of hyperglycemic events, and to assess clinical, anti-tumor benefit of the triplet therapy. The purpose of this study is: * to characterize the safety of the triplet drug combination consisting of either alpelisib or capivasertib (per the treating oncologist's choice) and fulvestrant plus evexomostat, * to test whether evexomostat, when given in combination with either alpelisib or capivasertib and fulvestrant will reduce the number and severity of hyperglycemic events and/or reduce the number or dose of anti-diabetic medications needed to control the hyperglycemia for metabolically normal patients and those deemed at risk for capivasertib and alpelisib-induced hyperglycemia (insulin resistance, as measured by HOMA-IR, baseline elevated HbA1c or well-controlled type 2 diabetes), and * to assess preliminary anti-tumor efficacy for each combination and changes in key biomarkers and quality of life in this patient population.
Key facts
- Study ID
- NCT05455619
- Run by
- SynDevRx, Inc.
- People needed
- 52
- Starts
- 2022-08-26
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Loma Linda University Cancer Center — Loma Linda, California, United States (enrolling)
- Hoag Memorial Hospital Presbyterian — Newport, California, United States (enrolling)
- SHARP Healthcare — San Diego, California, United States (enrolling)
- Miami Cancer Institute at Baptist Health — Miami, Florida, United States (enrolling)
- Hope and Healing Cancer Services — Hinsdale, Illinois, United States (enrolling)
- Trinity Health — Ypsilanti, Michigan, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Doctors Hospital of Laredo — Laredo, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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