{"entity":{"id":"xaluritamig","kind":"drug","name":"Xaluritamig","aka":[],"tldr":"Xaluritamig is Amgen's T-cell engager for prostate cancer, now in two phase 3 trials, aiming to do for prostate cancer what tarlatamab did for small-cell lung cancer.","summary":"Phase 1 (ESMO 2024): PSA50 ~49% and confirmed responses in heavily pretreated mCRPC at high doses; CRS mostly grade 1-2 with step-up dosing. XALute (NCT06691984, n≈675, post-taxane, vs cabazitaxel or ARPI, OS primary; active, not recruiting) and XALience (with abiraterone, chemo-naive mCRPC).","status":"phase-3","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT06691984","url":"https://clinicaltrials.gov/study/NCT06691984"},{"label":"XALience trial in progress (ASCO 2026)","url":"https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.TPS5144"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["t-cell-engager"],"targets":["steap1","cd3"],"drugs":[],"companies":["amgen"],"institutions":[],"pathways":[],"terms":["crs","psa50"],"trials":["xalute","nct07213674"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"AMG 509","modality":"Bispecific T-cell engager (STEAP1×CD3, XmAb 2+1)","mechanism":"Two STEAP1-binding domains and one CD3 arm (avidity for high-STEAP1 cells) redirect T cells.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/xaluritamig/","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":"cd3","kind":"target","name":"CD3","route":"/targets/cd3/"},{"id":"steap1","kind":"target","name":"STEAP1","route":"/targets/steap1/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"}],"term":[{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"psa50","kind":"term","name":"PSA50 / PSA90 response","route":"/terms/psa50/"}],"trial":[{"id":"nct07213674","kind":"trial","name":"A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate ","route":"/trials/nct07213674/"},{"id":"xalute","kind":"trial","name":"XALute","route":"/trials/xalute/"}]}}