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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:
    22d
    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)
    1m
    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)
    1m
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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)
    3ms
    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)
    3ms
    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)
    4ms
    Clinical Pharmacology Characterization and Dose Selection of Xaluritamig, a Next Generation XmAb® 2+1 T-Cell Engager, in Prostate Cancer Patients. (PubMed, J Clin Pharmacol)
    Additionally, thorough dose-exposure-response analyses integrated observed data and model-based simulations of PK, key efficacy endpoints, and safety events to support the evaluation of the target doses 0.75 mg QW, 1.5 mg QW, and 1.5 mg Q2W in dose expansion. This work provides the framework for which modeling and simulations can be used to guide dose selection for dose expansion at an early stage of development adhering to the recent principles of Project Optimus.
    Journal
    |
    STEAP1 (STEAP Family Member 1)
    |
    xaluritamig (AMG 509)
    4ms
    Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer (clinicaltrials.gov)
    P1, N=40, Recruiting, Amgen | N=30 --> 40 | Trial completion date: Oct 2029 --> Jan 2030 | Trial primary completion date: Jun 2026 --> Sep 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    STEAP1 (STEAP Family Member 1)
    |
    xaluritamig (AMG 509)
    5ms
    Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer (clinicaltrials.gov)
    P1, N=50, Recruiting, Amgen | Trial completion date: Mar 2029 --> Jun 2029 | Trial primary completion date: Sep 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    STEAP1 (STEAP Family Member 1)
    |
    xaluritamig (AMG 509)
    6ms
    T-Cell Engager Therapy in Prostate Cancer: Molecular Insights into a New Frontier in Immunotherapy. (PubMed, Cancers (Basel))
    While early PSMA-targeted TCEs established proof-of-concept, recent data, notably for six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeting agents like Xaluritamig, demonstrate more substantial objective responses, highlighting progress through improved target selection and molecular design...Accumulating evidence supports TCEs becoming a new therapeutic pillar for advanced PCa, but achieving this demands sustained innovation focused on optimizing efficacy and safety. This review critically connects molecular engineering advancements with clinical realities and future imperatives.
    Review • Journal • IO biomarker
    |
    DLL3 (Delta Like Canonical Notch Ligand 3) • STEAP1 (STEAP Family Member 1)
    |
    xaluritamig (AMG 509)