Xaluritamig

DRUG8 trials

Sponsors

Amgen, Thomas Jefferson University

Conditions

Ewing SarcomaHigh Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate CancerHigh-risk Biochemical RecurrenceMetastatic Castrate Resistant Prostate CancerMetastatic Castration-resistant Prostate CancerMetastatic Castration-resistant Prostate Cancer (mCRPC)Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Non-metastatic Castration-sensitive Prostate Cancer

Phase 1

Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

Active, not recruitingNCT06555796

AmgenHigh-risk Biochemical Recurrence, High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer, Non-metastatic Castration-sensitive Prostate Cancer +1

Start: 2024-09-23End: 2029-05-07Updated: 2026-09-04

Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

RecruitingNCT06613100

AmgenProstate Cancer

Start: 2024-11-25End: 2030-03-04Target: 40Updated: 2026-07-31

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

RecruitingNCT07140900

AmgenMetastatic Hormone-sensitive Prostate Cancer (mHSPC)

Start: 2025-10-07End: 2030-03-30Target: 60Updated: 2026-07-02

Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)

RecruitingNCT07297979

AmgenEwing Sarcoma

Start: 2026-04-08End: 2030-05-26Target: 50Updated: 2026-08-21

Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer

RecruitingNCT07493512

AmgenMetastatic Castration-resistant Prostate Cancer (mCRPC)

Start: 2026-04-28End: 2030-07-30Target: 40Updated: 2026-09-15

Phase 2

LuX: Xaluritamig in Participants With Metastatic Castrate Resistant Prostate Cancer and Suboptimal Response to Lutetium 177 Vipivotide Tetraxetan

Not yet recruitingNCT07737925

Thomas Jefferson UniversityMetastatic Castrate Resistant Prostate Cancer, Prostate Cancer

Start: 2026-10-01End: 2031-10-01Target: 30Updated: 2026-08-14

Phase 3

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 recruitingNCT06691984

AmgenMetastatic Castration-resistant Prostate Cancer

Start: 2024-12-09End: 2029-07-30Updated: 2026-05-15

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

RecruitingNCT07213674

AmgenMetastatic Castration-resistant Prostate Cancer

Start: 2025-11-28End: 2032-08-30Target: 750Updated: 2026-09-11

Related Papers

XALience: A phase 3, open-label, multicenter, randomized study of xaluritamig plus abiraterone vs investigator’s choice in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer.

Journal of Clinical Oncology2026-05-28

A phase 1b study of xaluritamig (a STEAP1 x CD3 T-cell engager) in pediatric, adolescent, and adult patients with relapsed/refractory (R/R) Ewing sarcoma.

Journal of Clinical Oncology2026-05-28

Initial results of a phase 1 dose exploration and expansion study of xaluritamig plus abiraterone acetate (AA) in patients (pts) with mCRPC.

Journal of Clinical Oncology2026-05-27

Trial in progress (XALute): Phase 3 study of xaluritamig vs investigator’s choice of cabazitaxel or second androgen receptor directed therapy (ARDT) in post-taxane metastatic castration-resistant prostate cancer (mCRPC).

Journal of Clinical Oncology2025-05-282 citations

Abstract 727: Association of baseline tumor and peripheral biomarker features with efficacy in metastatic castration-resistant prostate cancer patients treated with xaluritamig

Cancer Research2025-04-211 citations

A phase 1b, open-label, multicenter study of xaluritamig in patients with biochemical recurrence of prostate cancer after definitive therapy.

Journal of Clinical Oncology2025-02-101 citations

A phase 1b, open-label, multicenter study of xaluritamig in patients with newly diagnosed localized intermediate- or high-risk prostate cancer in the neoadjuvant setting.

Journal of Clinical Oncology2025-02-10