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OncoMatch/Clinical Trials/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

Is NCT07140900 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Xaluritamig and Darolutamide for metastatic hormone-sensitive prostate cancer (mhspc).

Phase 1RecruitingAmgenNCT07140900Data as of May 2026

Treatment: Xaluritamig · Darolutamide · AbirateroneThe main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Prior therapy

Must have received: androgen deprivation therapy (LHRH agonist, LHRH antagonist, orchiectomy) — first treatment, started no longer than 12 weeks before screening

started androgen deprivation therapy (ADT) (luteinising hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without androgen receptor pathway inhibitor (ARPI) (defined as abiraterone OR darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening

Cannot have received: docetaxel (docetaxel)

Prior docetaxel treatment is not permitted

Cannot have received: STEAP1-targeted therapy

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

Cannot have received: radioligand therapy

Prior radioligand therapy (RLT)

Cannot have received: PARP inhibitor

poly-adenosine diphosphate ribose polymerase (PARP) inhibitor

Cannot have received: cytotoxic chemotherapy

cytotoxic chemotherapy

Cannot have received: aminoglutethimide (aminoglutethimide)

aminoglutethimide

Cannot have received: ketoconazole (ketoconazole)

ketoconazole for prostate cancer

Cannot have received: systemic biologic therapy

any prior systemic biologic therapy, including immunotherapy for prostate cancer

Cannot have received: androgen receptor pathway inhibitor (enzalutamide, apalutamide)

Exception: within 15 days prior to enrollment

Prior enzalutamide or apalutamide within 15 days prior to enrollment

Cannot have received: radiation therapy

Exception: palliative radiation within 2 weeks prior to first dose of study treatment is allowed

Prior radiotherapy (to the prostate and/or to all visible metastatic lesions in a metastasis-directed therapy approach); palliative radiation within 2 weeks prior to first dose of study treatment is allowed

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

US trial sites

  • Dana Farber Cancer Institute · Boston, Massachusetts
  • University of Minnesota · Minneapolis, Minnesota
  • Sarah Cannon Research Institute · Nashville, Tennessee

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

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