Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Trial Title: Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

NCT ID: NCT06613100

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Xaluritamig
AMG509
Localized Prostate Cancer
Prostate Cancer
Neoadjuvant Therapy
Immunotherapy
T-Cell Engager
STEAP1

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Xaluritamig
Description: Intravenous (IV) infusion
Arm group label: Xaluritamig

Other name: AMG 509

Summary: The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered in the neoadjuvant setting followed by radical prostatectomy and to evaluate the feasibility and safety of a radical prostatectomy following xaluritamig administered in the neoadjuvant setting.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Subjects are eligible to be included in the study only if all the following criteria apply: - Subjects planned to undergo radical prostatectomy. - Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. Intermediate- or high-risk localized prostate cancer, defined as: - Gleason score of 4+3 or higher AND iPSA >10 OR - Clinically advanced (cT3) on MRI imaging obtained within 3 months prior to screening AND/OR - Positive locoregional lymph nodes as detected by PSMA-PET scans OR equal or ≤ 5 local lymph nodes on MRI can be enrolled. - Subjects must have undergone a gallium-68 prostate-specific membrane antigen (68Ga-PSMA-11) or a piflufolastat F 18 PET (CT or MRI) scan within 3 months prior to screening as part of the SOC. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Exclusion Criteria: Subjects are excluded from the study if any of the following criteria apply: - Prior treatment for subject's prostate cancer. - 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. - Subject 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: - Subject has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the subject may be considered eligible for the study from an infection standpoint. - History of arterial or venous thrombosis or other diseases requiring permanent anticoagulation (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis): - Patients requiring anticoagulation due to atrial fibrillation may be allowed if they can safely stop the anticoagulation for the perisurgical timeframe. - 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 - 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.

Gender: Male

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: October 31, 2024

Completion date: September 30, 2029

Lead sponsor:
Agency: Amgen
Agency class: Industry

Source: Amgen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06613100
http://www.amgentrials.com