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    DRUG:

    xaluritamig (AMG 509)

    i
    Other names: AMG 509, AMG509, AMG-509
    Company:
    Amgen, BeOne Medicines, Xencor
    Drug class:
    CD3 agonist, STEAP1 inhibitor
    Related drugs:
    11d
    Precision-Engineered CD3 T-Cell Engagers for Solid Tumours: Conditional Activation, Microenvironment Modulation, and Clinical Translation. (PubMed, Cancers (Basel))
    Next-generation TCE platforms integrating conditional activation, cytokine payloads, and checkpoint modulation-deployed with biomarker-guided selection and TME-modulating combinations-represent a transformative therapeutic strategy. With tarlatamab's phase III survival benefit establishing clinical proof-of-concept, and pivotal trials underway for xaluritamig and next-generation agents, TCEs are positioned to become standard-of-care platform therapies in biomarker-defined solid tumours by 2028-2030.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3) • DLL3 (Delta Like Canonical Notch Ligand 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • STEAP1 (STEAP Family Member 1)
    |
    Blincyto (blinatumomab) • Imdelltra (tarlatamab-dlle) • Tecvayli (teclistamab-cqyv) • xaluritamig (AMG 509)
    28d
    Novel Immunotherapeutic Strategies for Castration-Resistant Prostate Cancer: Mechanisms and Clinical Advances. (PubMed, Curr Issues Mol Biol)
    These collective findings suggest the potential of immunotherapy for CRPC in overcoming resistance barriers and improving patient outcomes, with bispecific T cell engagers (Xaluritamig, 59% PSA50) and PSMA-directed CAR-T therapy (P-PSMA-101, >50% PSA reduction) emerging as the most promising near-term candidates and biomarker-stratified combinations (nivolumab plus rucaparib, 84.6% PSA50, in HRR-deficient patients) illustrating the transformative power of precision patient selection; however, these findings require validation in larger, biomarker-stratified trials before definitive conclusions can be drawn. Translating this potential into clinical reality requires optimized patient selection through predictive biomarkers and rigorously validated Phase III trials to confirm durable clinical responses and long-term survival benefits.
    Review • Journal • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    MUC1 (Mucin 1)
    |
    Opdivo (nivolumab) • Rubraca (rucaparib) • xaluritamig (AMG 509)
    1m
    Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, Amgen
    New P1 trial
    |
    xaluritamig (AMG 509)
    1m
    Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute) (clinicaltrials.gov)
    P3, N=675, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • xaluritamig (AMG 509)
    2ms
    Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS) (clinicaltrials.gov)
    P1, N=50, Recruiting, Amgen | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EWSR1 (EWS RNA Binding Protein 1) • ERG (ETS Transcription Factor ERG) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor)
    |
    xaluritamig (AMG 509)
    2ms
    20230239: Phase 3 Study of Xaluritamig Plus Abiraterone vs Investigator's Choice in Chemotherapy-nave Metastatic Castration-resistant Prostate Cancer (2025-520555-89-00)
    P2/3, N=295, Recruiting, Amgen Inc.
    New P2/3 trial
    |
    docetaxel • abiraterone acetate • cabazitaxel • Sylvant (siltuximab) • xaluritamig (AMG 509)
    3ms
    Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS) (clinicaltrials.gov)
    P1, N=50, Not yet recruiting, Amgen | Trial completion date: Jul 2029 --> Apr 2030 | Trial primary completion date: Jul 2029 --> Apr 2030
    Trial completion date • Trial primary completion date
    |
    EWSR1 (EWS RNA Binding Protein 1) • ERG (ETS Transcription Factor ERG) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor)
    |
    xaluritamig (AMG 509)
    3ms
    Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer (clinicaltrials.gov)
    P1, N=50, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | Trial completion date: Jun 2029 --> Dec 2028 | Trial primary completion date: Apr 2027 --> Oct 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    STEAP1 (STEAP Family Member 1)
    |
    xaluritamig (AMG 509)
    3ms
    A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P3, N=750, Recruiting, Amgen | Trial primary completion date: Aug 2028 --> Jan 2030
    Trial primary completion date
    |
    docetaxel • abiraterone acetate • cabazitaxel • xaluritamig (AMG 509)
    4ms
    Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS) (clinicaltrials.gov)
    P1, N=50, Not yet recruiting, Amgen
    New P1 trial
    |
    xaluritamig (AMG 509)
    5ms
    Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer (clinicaltrials.gov)
    P1, N=40, Recruiting, Amgen | Trial primary completion date: Sep 2026 --> Jan 2027
    Trial primary completion date
    |
    STEAP1 (STEAP Family Member 1)
    |
    xaluritamig (AMG 509)
    6ms
    Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer (clinicaltrials.gov)
    P1, N=50, Recruiting, Amgen | Trial primary completion date: Dec 2026 --> Apr 2027
    Trial primary completion date
    |
    STEAP1 (STEAP Family Member 1)
    |
    xaluritamig (AMG 509)