Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
NCT ID: NCT06613100
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2024-11-25
2030-01-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A - Xaluritamig
Xaluritamig will be administered prior to radical prostatectomy.
Xaluritamig
Intravenous (IV) infusion
Cohort B - Xaluritamig with an Oral GnRH Antagonist
Xaluritamig will be administered prior to radical prostatectomy. Participants will also receive an oral GnRH antagonist continuously up to the time of planned radical prostatectomy.
Xaluritamig
Intravenous (IV) infusion
GnRH Antagonist
Oral administration
Interventions
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Xaluritamig
Intravenous (IV) infusion
GnRH Antagonist
Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
MALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of California San Francisco
San Francisco, California, United States
Washington University
St Louis, Missouri, United States
The Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, , Germany
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2024-511965-13
Identifier Type: OTHER
Identifier Source: secondary_id
20230237
Identifier Type: -
Identifier Source: org_study_id