{"entity":{"id":"xalute","kind":"trial","name":"XALute","aka":[],"tldr":"XALute is the phase 3 test of the first T-cell engager for prostate cancer.","summary":"XALute, trial NCT06691984 sponsored by Amgen, is the phase 3 test of xaluritamig, the first T-cell engager for prostate cancer, which targets STEAP1 and CD3. It randomises about 675 men with metastatic castration-resistant prostate cancer after an androgen receptor pathway inhibitor and a taxane, two to one, to xaluritamig or investigator's choice of cabazitaxel or a second androgen receptor inhibitor, with overall survival as the primary endpoint; it was active and no longer recruiting in May 2026, with no results yet. OnCo links it to STEAP1 as a target and to xaluritamig and cabazitaxel, and the companion XALience trial tests xaluritamig with abiraterone in chemotherapy-naive disease. Whether a T-cell engager can improve survival in a common solid tumour, with side effects manageable outside specialist centres, is the question it will answer.","status":"active","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT06691984","url":"https://clinicaltrials.gov/study/NCT06691984"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["t-cell-engager"],"targets":["steap1"],"drugs":["xaluritamig","cabazitaxel"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06691984","phase":"3","setting":"mCRPC after ARPI and taxane: xaluritamig vs cabazitaxel or second ARPI (investigator's choice; ≥50% cabazitaxel)","sponsor":"Amgen","started":"2024-12-09","startedType":"actual","enrolled":707,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing phase 3 of xaluritamig vs cabazitaxel/ARPI; no results."},"route":"/trials/xalute/","neighbours":{"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"steap1","kind":"target","name":"STEAP1","route":"/targets/steap1/"}],"drug":[{"id":"cabazitaxel","kind":"drug","name":"Cabazitaxel","route":"/drugs/cabazitaxel/"},{"id":"xaluritamig","kind":"drug","name":"Xaluritamig","route":"/drugs/xaluritamig/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"}]}}