{"entity":{"id":"nct05455619","kind":"trial","name":"Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer","aka":["Amelia-1"],"tldr":"A phase 1/2 trial of Evexomostat in advanced solid tumours, run by SynDevRx, Inc., now recruiting.","summary":"Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer is a phase 1/2 interventional study registered as NCT05455619 by SynDevRx, Inc., with 52 participants planned, started 2022-08-26 and due to reach its primary completion in 2026-12. Interventions recorded: Evexomostat.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05455619","url":"https://clinicaltrials.gov/study/NCT05455619"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["evexomostat"],"companies":["syndevrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05455619","phase":"1/2","setting":"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)","sponsor":"SynDevRx, Inc.","participation":[{"nct":"NCT05455619","source":"https://clinicaltrials.gov/study/NCT05455619","fetchedAt":"2026-10-07T16:53:42.604Z","studySha256":"17d86f9ca7783171ef8d40c4a20696b79a3da87ec79a72b0960bade877e00d2e","overallStatus":"RECRUITING","lastUpdatePosted":"2026-04-22","leadSponsor":"SynDevRx, Inc.","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":52,"enrolmentType":"ESTIMATED","siteCount":10,"recruitingSiteCount":10,"countries":["United States"]}],"started":"2022-08-26","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05455619/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"drug":[{"id":"evexomostat","kind":"drug","name":"Evexomostat","route":"/drugs/evexomostat/"}],"company":[{"id":"syndevrx","kind":"company","name":"SynDevRx","route":"/companies/syndevrx/"}]}}