Trial Profile

Study to Assess the Safety and Efficacy of Evexomostat (SDX-7320) in Combination With A PI3K or Akt Inhibitor Plus Fulvestrant in Patients With HR+, HER2-, Metastatic Breast Cancer With PI3K Pathway Alteration(s)

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 21 May 2026

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At a glance

Drugs Alpelisib (Primary) ; Capivasertib (Primary) ; Evexomostat (Primary) ; Fulvestrant (Primary)
Indications Advanced breast cancer; HER2 negative breast cancer
Focus Adverse reactions; Proof of concept
Acronyms Amelia-1
Sponsors SynDevRx, Inc

22 Apr 2026 Planned End Date changed from 1 Sep 2026 to 1 Mar 2027.
22 Apr 2026 Planned primary completion date changed from 1 Mar 2026 to 1 Dec 2026.
06 Jun 2023 Trial design presented at the 59th Annual Meeting of the American Society of Clinical Oncology

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