Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
NCT ID: NCT06555796
Last Updated: 2025-10-30
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
50 participants
INTERVENTIONAL
2024-09-23
2029-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Xaluritamig
Xaluritamig will be administered as a short-term intravenous (IV) infusion for a total of 6 cycles. One treatment cycle consists of 28 days.
Xaluritamig
IV infusion
Interventions
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Xaluritamig
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prostate cancer initially treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both (eg, salvage radiotherapy), with curative intent.
* PSA doubling time ≤ 12 months.
* Participants must have biochemically recurrent disease after definitive treatment to prostate by either RP or XRT.
* Screening PSA by the local laboratory ≥ 0.2 ng/mL for participants who had RP (with or without XRT) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir (local assessments) for participants who had XRT or brachytherapy only as primary treatment for prostate cancer.
* Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).
* Participants must have undergone a prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan during or within 3 months of screening.
Exclusion Criteria
* Participants that present PSMA-positive lesions in the PSMA PET scan may be enrolled if the conventional imaging does not show suspicion of metastatic disease.
* Prior hormonal therapy, exceptions include:
* Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before enrollment, or
* A single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before enrollment.
* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, enzalutamide, apalutamide, or darolutamide for prostate cancer.
* Abiraterone acetate, enzalutamide, apalutamide, or darolutamide are allowed if administered in a neoadjuvant/adjuvant setting ≤ 36 months in duration and ≥ 9 months before enrollment.
* Prior systemic biologic therapy, including immunotherapy, for prostate cancer.
* If, in the investigator's opinion, salvage therapy is the preferred intervention.
* Autoimmune disease requiring systemic immunosuppression within the past 2 years.
* Participant 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.
* Requirement for chronic systemic corticosteroid therapy (prednisone dose \> 10 mg/day or equivalent) or any other immunosuppressive therapies (including anti tumor necrosis factor alpha \[TNFα\] therapies) unless stopped (with adequate tapering) within 7 days prior to dosing.
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 Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
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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20230238
Identifier Type: -
Identifier Source: org_study_id
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