OnCo
drugsProductPhase 3

Xaluritamig

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.

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 as of mid-2026) and XALience (with abiraterone, chemo-naive mCRPC).

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Xaluritamig (AMG 509) Fab bound to STEAP1 (cryo-EM) (PDB 8UCD), backbone trace
RCSB PDB
How it works, step by step · animated schematic, not to scale
T-cell engagers (bispecific)
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.
Brand / code
AMG 509

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
3 studies1 recruiting1 Phase 22 Phase 3
Search “Xaluritamig” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Xaluritamig
intervention: Xaluritamig
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Landmark trials in OnCo

Latest papers

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Literature trend4 papers in the last 12 monthsHow this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Xaluritamig" OR ABSTRACT:"Xaluritamig" OR TITLE:"AMG 509" OR ABSTRACT:"AMG 509") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Xaluritamig, not a curated reading list.

Connected

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