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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:
    21h
    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)
    12d
    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)
    25d
    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)
    2ms
    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)
    3ms
    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)
    3ms
    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)
    4ms
    STEAP1-targeted strategies in advanced prostate cancer: a review on therapeutic and diagnostic implications. (PubMed, Prostate Cancer Prostatic Dis)
    STEAP1 represents a promising diagnostic and therapeutic target in prostate cancer, and its potential role in shaping future management of the disease warrants continued investigation.
    Review • Journal
    |
    STEAP1 (STEAP Family Member 1)
    |
    vandortuzumab vedotin (RG7450) • xaluritamig (AMG 509)
    4ms
    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
    New P3 trial
    |
    docetaxel • abiraterone acetate • cabazitaxel • xaluritamig (AMG 509)
    4ms
    Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, Amgen | Not yet recruiting --> Recruiting
    Enrollment open
    |
    abiraterone acetate • Nubeqa (darolutamide) • xaluritamig (AMG 509)
    5ms
    Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=479, Recruiting, Amgen | Trial completion date: Aug 2028 --> Mar 2032 | Trial primary completion date: Feb 2026 --> Mar 2030
    Trial completion date • Trial primary completion date
    |
    STEAP1 (STEAP Family Member 1)
    |
    abiraterone acetate • xaluritamig (AMG 509)
    5ms
    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, Recruiting, Amgen | Trial completion date: May 2030 --> Jul 2029
    Trial completion date
    |
    Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • xaluritamig (AMG 509)
    5ms
    Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, Amgen
    New P1 trial
    |
    abiraterone acetate • Nubeqa (darolutamide) • xaluritamig (AMG 509)