Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• HR+/HER2-negative Breast Cancer
• Metastatic Breast Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1/2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

SynDevRx, Inc.

Last updated on ClinicalTrials.gov

April 22, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites