578-25 | Study to test the safety and efficacy of evexomostat with other treatments for patients with certain types of advances breast cancer

Overview

“A Phase 1b/2 Study Assessing the Safety and Efficacy of Evexomostat (SDX-7320) in Combination with a PI3K Pathway Inhibitor plus Fulvestrant in Men and Postmenopausal Women with Advanced Breast Cancer and PI3K Pathway Alterations Who Have Progressed on or Following Endocrine Therapy plus a CDK4/6 Inhibitor”

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.