Actively Recruiting
Study Evaluating Safety, Tolerability, and Efficacy of Xaluritamig with Androgen Receptor Pathway Inhibitors in Men With Metastatic Hormone-sensitive Prostate Cancer
Led by Amgen · Updated on 2026-05-05
60
Participants Needed
14
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of xaluritamig combined with androgen receptor pathway inhibitors in men with metastatic hormone-sensitive prostate cancer. The trial focuses on participants who have a specific type of prostate cancer confirmed by tissue tests and have high-volume metastatic disease. This phase 1b, open-label study aims to understand how these drug combinations work together and their safety profile in this patient group. Participants receive intravenous xaluritamig combined with either oral darolutamide or oral abiraterone. There are two treatment groups: one receiving xaluritamig with darolutamide, and the other receiving xaluritamig with abiraterone. After treatment begins, participants enter a long-term follow-up period lasting up to three years, or until withdrawal, loss to follow-up, or death. During the study, researchers monitor participants for treatment-emergent and treatment-related side effects, changes in vital signs, and laboratory test results over approximately 2.5 years. They also assess prostate-specific antigen (PSA) levels at six months and track progression times and drug concentrations for up to about 4.5 years. Safety and effectiveness measures are collected regularly, and participants are followed closely throughout the study duration.
CONDITIONS
Brief 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...
- Male participants aged 18 years or older
- Histological, pathological, or cytological confirmation of adenocarcinoma of the prostate (mixed histologies not permitted)
- De novo metastatic hormone-sensitive prostate cancer with no prior localized prostate cancer diagnosis
- Started androgen deprivation therapy (LHRH agonist/antagonist or orchiectomy) within 12 weeks before screening
- No prior docetaxel treatment
- High-volume metastatic disease defined as visceral metastasis and/or 4 or more bone metastases with at least one outside spine and pelvis
- Documented metastatic disease by bone scan or CT/MRI for soft tissue or visceral metastases
- PSA not progressing per PCWG3 after initial PSA nadir following androgen deprivation therapy
You will not qualify if you...
- History of central nervous system metastases
- Unresolved toxicities from prior anti-tumor therapy (except ongoing androgen deprivation therapy or androgen receptor pathway inhibitors) not resolved to CTCAE grade 1 or baseline, except stable alopecia or well-controlled toxicities with agreement
- Autoimmune disease requiring systemic immunosuppression within past 2 years
- Active or uncontrolled infection within 7 days prior to first study treatment dose
- Prior STEAP1-targeted therapy
- Prior radioligand therapy, PARP inhibitor, chemotherapy, aminoglutethimide, ketoconazole, or systemic biologic/immunotherapy for prostate cancer
- Prior enzalutamide or apalutamide within 15 days before enrollment
- Need for chronic systemic corticosteroids over prednisone 10 mg/day or other immunosuppressive therapies unless stopped with tapering within 7 days before dosing
- Prior radiotherapy to prostate or visible metastatic lesions, except palliative radiation within 2 weeks before first study dose allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2.5 years
Participants receive Xaluritamig intravenously in combination with either darolutamide or abiraterone orally to treat metastatic hormone-sensitive prostate cancer.
Regular visits during treatment for drug administration and monitoring
Duration - Up to 3 years from first dose
Participants enter long-term follow-up for safety and efficacy assessments after starting treatment, continuing up to 3 years or until withdrawal, loss to follow-up, or death.
Periodic visits during follow-up
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
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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