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

Exclusion Criteria14

• History of central nervous system metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.
• History of allergic reactions or acute hypersensitivity reactions to the components of the trial therapies and their analogs. Participants with known contraindications to high-dose corticosteroids are also excluded.
• History of malignancy that is expected to alter life expectancy or may interfere with disease assessments. Participants with prior history of malignancy that have been adequately treated and who have been disease-free for >3 years are eligible, as are participants with adequately treated non-melanoma skin cancer or superficial bladder cancer.
• Active autoimmune disease that has required systemic treatment (except physiologic replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on trial.
• Known positive test for human immunodeficiency virus.
• Presence or history of viral hepatitis infection.
• Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of trial treatment with the following exceptions:
• Androgen-deprivation therapy with luteinizing hormone-releasing hormone/gonadotropin-releasing hormone (LHRH/GnRH) analogue (agonist/antagonist) is allowed.
• ARPIs (enzalutamide, abiraterone, apalutamide, darolutamide) require a minimum washout of 2 weeks prior to the first dose of xaluritamig.
• Prior prostate-specific membrane antigen (PSMA) radionuclide therapy cannot be given within 3 months prior to first dose of xaluritamig unless participant received <2 cycles of therapy, in which case participant cannot have received PSMA radionuclide therapy within 35 days prior to first dose.
• Any prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
• Any prior cluster of differentiation 3 (CD3)-directed therapy.
• Requirement for chronic systemic corticosteroid therapy (prednisone dose >10 mg/day or equivalent) or any other immunosuppressive therapies (including anti TNFα therapies).
• Participation on any other xaluritamig trial, regardless of whether xaluritamig was administered.