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XALute is the phase 3 test of the first T-cell engager for prostate cancer.
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.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Xaluritamig, Cabazitaxel, Amgen, T-cell engagers (bispecific).
Shares STEAP1, Prostate cancer.
Shares Cabazitaxel, Metastatic castration-resistant prostate cancer, Prostate cancer.
Shares Cabazitaxel, Metastatic castration-resistant prostate cancer, Prostate cancer.
Shares Amgen, T-cell engagers (bispecific).
Shares Amgen, T-cell engagers (bispecific).
Shares Metastatic castration-resistant prostate cancer, Prostate cancer.
Shares T-cell engagers (bispecific), Metastatic castration-resistant prostate cancer, Prostate cancer.
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