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.
HR+/HER2-negative Breast Cancer, Metastatic Breast Cancer
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.
Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer
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Loma Linda University Cancer Center, Loma Linda, California, United States, 92354
Hoag Memorial Hospital Presbyterian, Newport, California, United States, 92663
SHARP Healthcare, San Diego, California, United States, 92123
Miami Cancer Institute at Baptist Health, Miami, Florida, United States, 33176
Hope and Healing Cancer Services, Hinsdale, Illinois, United States, 60521
Trinity Health, Ypsilanti, Michigan, United States, 48197
Cleveland Clinic, Cleveland, Ohio, United States, 44195
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States, 17033
Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232
Doctors Hospital of Laredo, Laredo, Texas, United States, 78045
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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18 Years to
ALL
No
SynDevRx, Inc.,
Medical Team, STUDY_DIRECTOR, SynDevRx, Inc.
2026-09