Xaluritamig (AMG 509) is an investigational STEAP1-targeted CD3 T-cell engager immunotherapy for prostate cancer and other tumor settings under active clinical development. Reported first-in-human data in metastatic castration-resistant prostate cancer support ongoing later-phase evaluation. It is not approved for marketing.
Amgen shares have climbed 35% over six months, trading near $388, as analysts raise price targets following strong fourth-quarter 2025 results and expanding oncology pipeline programs including IMDELLTRA and LUMAKRAS.
Multiple pharmaceutical companies have initiated clinical trials for metastatic castration-resistant prostate cancer in February 2026, with over 180 companies developing 200+ pipeline therapies. Studies include combination therapies and novel drug candidates targeting advanced disease.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07493512 |
Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer |
RECRUITING | PHASE1 |
| NCT07297979 |
Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS) |
RECRUITING | PHASE1 |
| NCT07213674 |
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer |
RECRUITING | PHASE3 |
| NCT07140900 |
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer |
RECRUITING | PHASE1 |
| NCT06691984 |
Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06613100 |
Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer |
RECRUITING | PHASE1 |
| NCT06555796 |
Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer |
ACTIVE_NOT_RECRUITING | PHASE1 |
