Study of Xaluritamig for Metastatic Hormone-Sensitive Prostate Cancer
This study is testing a new drug called xaluritamig in combination with either darolutamide or abiraterone for men with metastatic hormone-sensitive prostate cancer (mHSPC). This means your prostate cancer has spread to other parts of your body but still responds to hormone therapy. The main goal is to see how safe xaluritamig is and how well your body tolerates it when given with these other medications. The study plans to enroll 60 participants. The current status of the study is unclear, so it's not known if they are actively recruiting.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 60 adult men.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for treatment-emergent and treatment-related side effects, and changes in vital signs for up to approximately 2.5 years.
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NCT07140900
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentAmgen
~60 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:XaluritamigDarolutamideAbiraterone
At a glance
Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-emergent Adverse Events
Measured over Up to approximately 2.5 years
+3 more outcomes measured
Conditions
Where it's being run
16 sites across 10 statesVictoria3
Switzerland3
Pennsylvania2
New South Wales2
California1
Massachusetts1
Minnesota1
Ohio1
Study leadership
- MD · STUDY_DIRECTOR · Amgen
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
Participants must have at the time of diagnosis:
De novo (synchronous) mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer, AND started ADT (LHRH agonist/antagonist or orchiectomy) with or without ARPI (defined as abiraterone OR darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening. Prior docetaxel treatment is not permitted.
Participants must have at the time of diagnosis:
High-volume metastatic disease defined as presence of visceral metastasis or metastases, and/or ≥ 4 bone metastases with at least one outside of the vertebral column and pelvis.
Documented metastatic disease either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan.
No documented PSA progression following the initial PSA nadir after starting ADT.
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 or systemic infection within 7 days prior to the first dose of study treatment.
Prior six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
Prior radioligand therapy (RLT), poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, cytotoxic chemotherapy, aminoglutethimide or ketoconazole for prostate cancer, or any prior systemic biologic therapy, including immunotherapy for prostate cancer.
Prior enzalutamide or apalutamide within 15 days prior to enrolment.
Requirement for chronic systemic corticosteroid therapy (prednisone dose greater than 10 mg per day or local equivalent) or any other immunosuppressive therapies (including anti TNFα therapies) unless stopped (with adequate tapering) within 7 days prior to dosing.
Prior radiotherapy to all metastatic sites of disease. Radiotherapy to some sites of metastatic disease for palliation will be permitted.
Exclusion
Prior history of central nervous system (CNS) metastases. Note: Participants with asymptomatic and clinically stable dural metastases are eligible.
What this trial measures
- Number of Participants with Treatment-emergent Adverse EventsUp to approximately 2.5 years
- Number of Participants with Treatment-related Adverse EventsUp to approximately 2.5 years
- Number of Participants with Clinically Significant Changes in Vital SignsUp to approximately 2.5 years
- Number of Participants with Clinically Significant Changes in Clinical Laboratory TestsUp to approximately 2.5 years