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Xaluritamig - Amgen/Xencor

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Drug Profile

Xaluritamig - Amgen/Xencor

Alternative Names: AMG-509

Latest Information Update: 29 Dec 2025

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At a glance

  • Originator Amgen; Xencor
  • Developer Amgen; BeOne Medicines; Xencor
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies
  • Mechanism of Action Cytotoxic T lymphocyte stimulants; Immunologic cytotoxicity
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Prostate cancer
  • No development reported Ewing's sarcoma

Most Recent Events

  • 22 Dec 2025 Amgen plans a phase Ib trial for Ewing's Sarcoma (In children, In adolescents, In adults, In the elderly, Second-line therapy or greater) in Unknown location (IV, Infusion) in January 2026 (NCT07297979)
  • 15 Oct 2025 Phase-III clinical trials in Prostate cancer (Combination therapy, Hormone refractory, Metastatic disease, Second-line therapy or greater) in USA (IV) (NCT07213674)
  • 09 Oct 2025 Amgen plans a phase III trial for Prostate cancer (Combination therapy, Hormone-refractory, Metastatic disease, Second-line therapy or greater) in unspecified location (IV) in October 2025 (NCT07213674)

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