# XALute

Source: https://onco.cc/trials/xalute/  
OnCo record `xalute` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-06
- Registry id: NCT06691984
- Phase: 3
- Setting: mCRPC after ARPI and taxane: xaluritamig vs cabazitaxel or second ARPI (investigator's choice; ≥50% cabazitaxel)
- Sponsor: Amgen
- Enrolled: 707
- Replication: Ongoing phase 3 of xaluritamig vs cabazitaxel/ARPI; no results.

## Sources

- ClinicalTrials.gov NCT06691984: https://clinicaltrials.gov/study/NCT06691984

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- targets: [STEAP1](https://onco.cc/targets/steap1/)
- drugs: [Cabazitaxel](https://onco.cc/drugs/cabazitaxel/), [Xaluritamig](https://onco.cc/drugs/xaluritamig/)
- companies: [Amgen](https://onco.cc/companies/amgen/)

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JSON: https://onco.cc/api/v1/entities/xalute.json