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 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 20240361
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 14

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)

Keywords

Prostate cancer; Xaluritamig

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Treatment-emergent Adverse Events

  Up to approximately 2.5 years

• Number of Participants with Treatment-related Adverse Events

  Up to approximately 2.5 years

• Number of Participants with Clinically Significant Changes in Vital Signs

  Up to approximately 2.5 years

• Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

  Up to approximately 2.5 years

Secondary Outcomes (10)

• Percentage of Participants with Prostate-specific Antigen (PSA) < 0.2 ng/mL at 6 Months

  6 months

• Time to PSA Progression

  Up to approximately 4.5 years

• Time to First New Systemic Anticancer Therapy

  Up to approximately 4.5 years

• Time to Radiographic Progression per Prostate Cancer Working Group 3 (PCWG3) Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  Up to approximately 4.5 years

• Observed Concentration at the End of a Dose Interval of Darolutamide

  Up to approximately 4.5 years

Study Arms (2)

Xaluritamig with Darolutamide

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.

Drug: Xaluritamig; Drug: Darolutamide

Xaluritamig with Abiraterone

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.

Drug: Xaluritamig; Drug: Abiraterone

Interventions

Xaluritamig DRUG

Participants will receive xaluritamig intravenously.

Also known as: AMG 509

Xaluritamig with Abiraterone; Xaluritamig with Darolutamide

Darolutamide DRUG

Participants will receive darolutamide orally.

Xaluritamig with Darolutamide

Abiraterone DRUG

Participants will receive abiraterone orally.

Xaluritamig with Abiraterone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• PSA not progressing per PCWG3 following the initial PSA nadir after starting ADT.

You may not qualify if:

• Prior history of central nervous system (CNS) metastases.
• 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 enrollment.
• 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 the prostate and/or to all visible metastatic lesions in a metastasis-directed therapy approach); palliative radiation within 2 weeks prior to first dose of study treatment is allowed.

Sponsors & Collaborators

• Amgen: lead

Study Sites (14)

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

Chris OBrien Lifehouse

Camperdown, New South Wales, 2050, Australia

RECRUITING

Calvary Mater Newcastle Hospital

Waratah, New South Wales, 2298, Australia

RECRUITING

Cabrini Hospital

Clayton, Victoria, 3168, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Kantonsspital Graubuenden

Chur, 7000, Switzerland

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

RECRUITING

Kantonsspital Sankt Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide; abiraterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 26, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): March 27, 2028
• Study Completion (Estimated): March 30, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

CH (3); AU (5); US (6)