Recruiting

Xaluritamig and Androgen Receptor Inhibitors for Metastatic Hormone-sensitive Prostate Cancer

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What is being tested

Xaluritamig

+ Abiraterone

+ Darolutamide

Drug
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorAmgen
Study ContactAmgen Call Center
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 7, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to assess a new treatment option for men with metastatic hormone-sensitive prostate cancer. The study focuses on evaluating the combination of a new drug, xaluritamig, with existing medications, darolutamide or abiraterone, which are used to inhibit the androgen receptor pathway involved in prostate cancer. The goal is to determine whether this combination is safe and can be tolerated by patients. Understanding the safety of this combination is crucial as it may lead to more effective treatments for prostate cancer that has spread and responds to hormone therapy. Participants in this study receive the treatment combination and are closely monitored to see how their bodies react. The study involves giving xaluritamig along with either darolutamide or abiraterone, which may be administered orally or by another method as determined by the medical team. Although the study does not specifically list outcomes, it likely involves monitoring for any side effects and assessing how well the treatment is tolerated. This information is vital for determining if further studies can continue with this combination to potentially improve treatment options for those affected by advanced prostate cancer.

Official TitleA Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
NCT07140900
Principal SponsorAmgen
Study ContactAmgen Call Center
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

5 inclusion criteria required to participate
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 mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer AND started androgen deprivation therapy (ADT) (luteinising hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without androgen receptor pathway inhibitor (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 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.
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9 exclusion criteria prevent from participating
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 enzalutamide or apalutamide within 15 days prior to enrollment.
Unresolved toxicities from prior anti-tumor therapy (excluding those related to ongoing ADT and ARPI) not having resolved to Common Terminology Criteria for Adverse events (CTCAE) version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.
Prior history of central nervous system (CNS) metastases.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive xaluritamig in combination with abiraterone. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first.

Group II

Experimental
Participants will receive xaluritamig in combination with darolutamide. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

Recruiting

Dana Farber Cancer Institute

Boston, United StatesOpen Dana Farber Cancer Institute in Google Maps
Recruiting

University of Minnesota

Minneapolis, United States
Recruiting

Sarah Cannon Research Institute

Nashville, United States
Recruiting

Chris OBrien Lifehouse

Camperdown, Australia
Recruiting
11 Study Centers