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Study of Xaluritamig for Localized Prostate Cancer

This study is looking at a new treatment called Xaluritamig, given through an IV, either by itself or with another oral medicine called a GnRH Antagonist. This treatment is for men with localized prostate cancer who are planning to have surgery (radical prostatectomy). The main goals are to see how safe Xaluritamig is and how well people tolerate it before surgery, and to check if surgery is still safe and possible after taking Xaluritamig. We are looking for about 40 men to join this study. To be eligible, you must be an adult male with confirmed prostate cancer who is scheduled for a radical prostatectomy.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 45 months to track side effects and up to 25 months to see if they had surgery after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06613100

Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Amgen
~40 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:XaluritamigGnRH Antagonist

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants who Experienced Treatment-emergent Adverse Events
Measured over Up to 45 months
+3 more outcomes measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

9 sites across 8 states
Germany2
California1
Missouri1
Ohio1
Pennsylvania1
South Carolina1
Washington1
Wisconsin1

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

Amgen Call Center
[email protected]
866-572-6436
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants 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 initial PSA (iPSA) \>10 OR
Clinically advanced (cT3) on Magnetic Resonance Imaging (MRI) obtained within 3 months prior to screening AND/OR
Positive locoregional lymph nodes as detected by prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans OR ≤ 5 local lymph nodes on MRI can be enrolled.
Participants must have undergone a PSMA-PET (CT or MRI) scan within 3 months prior to screening as part of the standard of care (SOC).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion

Prior treatment for participant'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.
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:
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.

What this trial measures

  • Number of Participants who Experienced Treatment-emergent Adverse EventsUp to 45 months

    Inclusive of adverse events, serious adverse events, and changes in vital signs and clinical laboratory tests.

  • Number of Participants who Experienced Treatment-related Adverse EventsUp to 28 months
  • Number of Participants who Received Radical Prostatectomy After Completing Xaluritamig TreatmentUp to 25 months
  • Number of Participants who Experienced Complications of Radical Prostatectomy According to Clavien-Dindo ClassificationUp to 28 months