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    DRUG CLASS:

    STEAP1 inhibitor

    Related drugs:
    8d
    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)
    21d
    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)
    1m
    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
    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)
    6ms
    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)
    6ms
    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)