Actively Recruiting
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
Led by Amgen · Updated on 2026-05-05
60
Participants Needed
14
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
CONDITIONS
Official Title
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed adenocarcinoma of the prostate by histology, pathology, or cytology; mixed histologies are not allowed.
- Participants must have de novo metastatic hormone-sensitive prostate cancer at diagnosis, with no prior localized prostate cancer diagnosis.
- Participants must have started androgen deprivation therapy (luteinising hormone-releasing hormone agonist/antagonist or orchiectomy) with or without androgen receptor pathway inhibitor (abiraterone or darolutamide) as first treatment no longer than 12 weeks before screening.
- Participants must have high-volume metastatic disease defined as visceral metastasis and/or 4 or more bone metastases with at least one outside the vertebral column and pelvis.
- Documented metastatic disease confirmed by positive bone scan or contrast-enhanced CT or MRI for soft tissue or visceral metastases.
- PSA must not be progressing according to PCWG3 after initial PSA nadir following androgen deprivation therapy.
You will not qualify if you...
- Prior history of central nervous system metastases.
- Unresolved toxicities from prior anti-tumor therapy (except ongoing androgen deprivation therapy and androgen receptor pathway inhibitor) not resolved to grade 1 or baseline, except alopecia or stable well-controlled toxicities with agreement.
- Autoimmune disease requiring systemic immunosuppression within the past 2 years.
- Symptoms, signs, or imaging indicating acute or uncontrolled active systemic infection within 7 days before first dose.
- Prior six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
- Prior radioligand therapy, PARP inhibitors, cytotoxic chemotherapy, aminoglutethimide, ketoconazole, or any systemic biologic therapy including immunotherapy for prostate cancer.
- Prior enzalutamide or apalutamide within 15 days before enrollment.
- Requirement for chronic systemic corticosteroids over 10 mg prednisone daily or other immunosuppressive therapies unless stopped with tapering within 7 days before dosing.
- Prior radiotherapy to the prostate or all visible metastatic lesions; palliative radiation allowed if more than 2 weeks before first dose.
AI-Screening
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Trial Site Locations
Total: 14 locations
1
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
6
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
8
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia, 2298
Actively Recruiting
9
Cabrini Hospital
Clayton, Victoria, Australia, 3168
Actively Recruiting
10
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
11
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
12
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Actively Recruiting
13
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Actively Recruiting
14
Kantonsspital Sankt Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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