Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer

A Phase 1b, Open-label Study of Xaluritamig (AMG 509) in Adults With Metastatic Castration-resistant Prostate Cancer

The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC).

Study Overview

• Status: Recruiting
• Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Intervention / Treatment: Drug: Xaluritamig

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• United States
  • Texas
    • Irving, Texas, United States, 75039
      • Recruiting
      • Next Oncology - Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
• mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scintigraphy imaging obtained within 28 days prior to enrollment.

• Evidence of progressive disease, defined as 1 or more PCWG3 criteria:

  • Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
  • Soft tissue progression defined as an increase ≥ 20% and an absolute increase of ≥ 5 mm in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
  • Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scintigraphy (as per the 2+2 PCWG3 criteria).
• Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).
• Prior progression on at least one androgen receptor pathway inhibitor (androgen receptor pathway inhibitor [ARPI], enzalutamide, abiraterone, apalutamide, darolutamide).
• Prior treatment with only one taxane therapy in the mCRPC setting. Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting.

Exclusion Criteria:

• History of central nervous system metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.
• History of allergic reactions or acute hypersensitivity reactions to the components of the trial therapies and their analogs. Participants with known contraindications to high-dose corticosteroids are also excluded.
• History of malignancy that is expected to alter life expectancy or may interfere with disease assessments. Participants with prior history of malignancy that have been adequately treated and who have been disease-free for >3 years are eligible, as are participants with adequately treated non-melanoma skin cancer or superficial bladder cancer.
• Active autoimmune disease that has required systemic treatment (except physiologic replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on trial.
• Known positive test for human immunodeficiency virus.
• Presence or history of viral hepatitis infection.

• Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of trial treatment with the following exceptions:

  • Androgen-deprivation therapy with luteinizing hormone-releasing hormone/gonadotropin-releasing hormone (LHRH/GnRH) analogue (agonist/antagonist) is allowed.
  • ARPIs (enzalutamide, abiraterone, apalutamide, darolutamide) require a minimum washout of 2 weeks prior to the first dose of xaluritamig.
  • Prior prostate-specific membrane antigen (PSMA) radionuclide therapy cannot be given within 3 months prior to first dose of xaluritamig unless participant received <2 cycles of therapy, in which case participant cannot have received PSMA radionuclide therapy within 35 days prior to first dose.
• Any prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
• Any prior cluster of differentiation 3 (CD3)-directed therapy.
• Requirement for chronic systemic corticosteroid therapy (prednisone dose >10 mg/day or equivalent) or any other immunosuppressive therapies (including anti TNFα therapies).
• Participation on any other xaluritamig trial, regardless of whether xaluritamig was administered.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xaluritamig Proposed Regimen; Participants will be dosed at the proposed regimen until disease progression or discontinuation of study treatment.	Drug: Xaluritamig; Participants will receive xaluritamig via short-term intravenous (IV) infusion.; Other Names: AMG 509

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-emergent Adverse Events	This will include treatment-emergent adverse events, serious adverse events, treatment-related adverse events, and fatal adverse events.	Up to 3.6 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration (Cmax) of Xaluritamig	Up to 1 Year
Time to Cmax (tmax) of Xaluritamig	Up to 1 Year
Accumulation Ratio (AR) Following Multiple Doses of Xaluritamig	Up to 1 Year
Serum Concentration Before Dosing (Ctrough) of Xaluritamig	Up to 1 Year
Area Under the Concentration-time Curve Over the Dosing Interval (AUC) of Xaluritamig	Up to 1 Year
Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Up to 3.6 Years
Duration of Response (DOR) per Modified RECIST v1.1	Up to 3.6 Years
Disease Control (DC) per Modified RECIST v1.1	Up to 3.6 Years
Time to Response (TTR) per Modified RECIST v1.1	Up to 3.6 Years
Number of Participants with a Prostate-specific Antigen (PSA) 50 Response	Up to 3.6 Years
Number of Participants with a PSA 90 Response	Up to 3.6 Years
Time to PSA 50 and PSA 90 Response	Up to 3.6 Years
Duration of PSA 50 and PSA 90 Response	Up to 3.6 Years
Time to PSA Progression	Up to 3.6 Years
Time to First Subsequent Therapy	Up to 3.6 Years
Radiographic Progression-free Survival (PFS) Per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1	Up to 3.6 Years
Overall Survival (OS)	Up to 3.6 Years

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): July 30, 2030

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; mCRPC; AMG 509; Xaluritamig
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 20250211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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 (or other new use) 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.
• IPD Sharing 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No