# Xaluritamig

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

## TL;DR

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).

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-06
- 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.

## Sources

- ClinicalTrials.gov NCT06691984: https://clinicaltrials.gov/study/NCT06691984
- XALience trial in progress (ASCO 2026): https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.TPS5144

## 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: [CD3](https://onco.cc/targets/cd3/), [STEAP1](https://onco.cc/targets/steap1/)
- companies: [Amgen](https://onco.cc/companies/amgen/)
- terms: [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [PSA50 / PSA90 response](https://onco.cc/terms/psa50/)
- trials: [A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate ](https://onco.cc/trials/nct07213674/), [XALute](https://onco.cc/trials/xalute/)

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