Recruiting
Phase 1

Xaluritamig, Darolutamide, Abiraterone

Sponsor:

Amgen

Code:

NCT07140900

Conditions

Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Xaluritamig

Darolutamide

Abiraterone

Study Details

Brief summary:

The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.

Conditions

Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Study ID

NCT07140900

Start date

Oct 7, 2025

Status verified date

Jun, 2026

Completion date

Mar 30, 2030

Anticipated

Primary completion date

Mar 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prior history of central nervous system (CNS) metastases. Note: Participants with asymptomatic and clinically stable dural metastases are eligible.
  • 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.
  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Xaluritamig with Darolutamide

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.

experimental: Xaluritamig with Abiraterone

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.

Interventions

Xaluritamig

Participants will receive xaluritamig intravenously.

Darolutamide

Participants will receive darolutamide orally.

Abiraterone

Participants will receive abiraterone orally.

Primary outcome measure

  • Number of Participants with Treatment-emergent Adverse Events [ Time Frame: Up to approximately 2.5 years ]
  • Number of Participants with Treatment-related Adverse Events [ Time Frame: Up to approximately 2.5 years ]
  • Number of Participants with Clinically Significant Changes in Vital Signs [ Time Frame: Up to approximately 2.5 years ]
  • Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [ Time Frame: Up to approximately 2.5 years ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

University of Pittsburgh Medical Center Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

South Texas Accelerated Research Therapeutics - Carolinas

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

Amgen

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Prostate cancer
  • Xaluritamig

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Amgen on 2026-07-02.