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OncoMatch/Clinical Trials/NCT06691984

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

Is NCT06691984 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Xaluritamig and Abiraterone for metastatic castration-resistant prostate cancer.

Phase 3RecruitingAmgenNCT06691984Data as of May 2026

Treatment: Xaluritamig · Abiraterone · Enzalutamide · CabazitaxelThe main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy \[ARDT\]).

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: androgen deprivation therapy

Participants must have had a prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).

Must have received: androgen receptor-directed therapy (enzalutamide, abiraterone, apalutamide, darolutamide)

Prior progression on at least one ARDT (enzalutamide, abiraterone, apalutamide, darolutamide).

Must have received: taxane — mCRPC

Prior treatment with only one taxane therapy in the mCRPC setting. Note: Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting.

Cannot have received: STEAP1-targeted therapy

Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.

Cannot have received: Prostate-Specific Membrane Antigen radioligand therapy

Exception: unless participants received < 2 cycles of therapy

Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 3 months of the first dose of study treatment unless participants received < 2 cycles of therapy.

Cannot have received: radionuclide therapy (Radium-223)

Prior radionuclide therapy (Radium-223) within 2 months of first dose of study treatment.

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Memorial Sloan Kettering Cancer Center · New York, New York
  • Montefiore Medical Center · The Bronx, New York
  • Levine Cancer Institute · Charlotte, North Carolina
  • Duke University · Durham, North Carolina
  • Sanford Roger Maris Cancer Center · Fargo, North Dakota

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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