Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Exclusion Criteria11

• Participants are excluded from the study if any of the following criteria apply:
• Prior treatment for participant's prostate cancer.
• \- Exception: Participants intended for enrollment in cohort B may have received an oral GnRH antagonist up to 3 months prior to the start of screening.
• Any evidence of metastases outside of the surgical resection field identified by conventional imaging or PSMA-PET scans.
• Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
• Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment:
• \- Participant has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.
• Recent history of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis) within 6 and 3 months prior to the first dose of study treatment, respectively. Note: Participants with a history of venous thrombosis must be on stable anti-coagulation.
• Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association ≥ class II) within 12 months of first dose of xaluritamig with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement more than 6 months prior to first dose of xaluritamig.
• Requirement for chronic systemic corticosteroid therapy unless stopped (with adequate tapering) within 7 days prior to dosing.
• Currently receiving treatment in another investigational device or drug study, or less than 4 weeks (since ending treatment on another investigational device or drug study\[ies\]). Other investigational procedures and participation in observational research studies while participating in this study are excluded with the exception of investigational scans.