Evexomostat with PI3K/AKT Inhibitor and Fulvestrant for HR+/HER2- Breast Cancer

This study is for adult men and postmenopausal women with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer. You may be eligible if your cancer has a change in the PI3K pathway, such as a PIK3CA mutation, PTEN loss, or AKT1 mutation. The study is testing the safety and effectiveness of a combination of three drugs: evexomostat, plus either alpelisib or capivasertib, and fulvestrant. Researchers want to see how well this "triplet therapy" works to shrink tumors and how many patients experience high blood sugar (hyperglycemia), which can be a side effect of some of these drugs. The study aims to understand the side effects and benefits of this new combination.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 52 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for side effects for up to 48 months, and for high blood sugar events for up to 42 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05455619

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
SynDevRx, Inc.
~52 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Evexomostat

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events
Measured over Up to 48 months
+1 more outcome measured
HR+/HER2-negative Breast Cancer
Metastatic Breast Cancer
10 sites across 8 states
California3
Florida1
Illinois1
Michigan1
Ohio1
Pennsylvania1
Tennessee1
Texas1
  • Medical Team · STUDY_DIRECTOR · SynDevRx, Inc.

Opens a ready-to-send draft in your own email app — review before sending.

  • Incidence of Adverse EventsUp to 48 months

    Safety and tolerability profile will be assessed by Common Terminology Criteria for Adverse Events v5.0 and summarized by type, frequency, and severity of adverse events of evexomostat dosed in combination with alpelisib plus fulvestrant

  • Hyperglycemic EventsUp to 42 months

    Severity, number, and proportion of patients with hyperglycemic events