Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, and Feasibility of Neoadjuvant Xaluritamig Therapy Prior to Radical Prostatectomy in Subjects With Newly Diagnosed Localized Intermediate or High-Risk Prostate Cancer

The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered as monotherapy or in combination with an oral Gonadotropin-releasing Hormone (GnRH) antagonist in the neoadjuvant setting followed by radical prostatectomy, and to evaluate the feasibility and safety of a radical prostatectomy following xaluritamig administered as monotherapy or in combination with an oral GnRH antagonist in the neoadjuvant setting.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Xaluritamig; Drug: GnRH Antagonist

• 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

• Germany
  • Essen, Germany, 45147
    • Recruiting
    • Universitaetsklinikum Essen
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitaetsklinikum Hamburg Eppendorf
• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Carolina Urologic Research Center
  • Washington
    • Seattle, Washington, United States, 98109-1023
      • Recruiting
      • Fred Hutchinson Cancer Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

• Participants planned to undergo radical prostatectomy.

• Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. Intermediate- or high-risk localized prostate cancer, defined as:

  • Gleason score of 4+3 or higher AND initial PSA (iPSA) >10 OR
  • Clinically advanced (cT3) on Magnetic Resonance Imaging (MRI) obtained within 3 months prior to screening AND/OR
  • Positive locoregional lymph nodes as detected by prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans OR ≤ 5 local lymph nodes on MRI can be enrolled.
• Participants must have undergone a PSMA-PET (CT or MRI) scan within 3 months prior to screening as part of the standard of care (SOC).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Prior treatment for participant's prostate cancer.

  - Exception: Participants intended for enrollment in cohort B may have received an oral GnRH antagonist up to 3 months prior to the start of screening.

• Any evidence of metastases outside of the surgical resection field identified by conventional imaging or PSMA-PET scans.
• Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.

• Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment:

  - Participant has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.

• Recent history of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis) within 6 and 3 months prior to the first dose of study treatment, respectively. Note: Participants with a history of venous thrombosis must be on stable anti-coagulation.
• Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association ≥ class II) within 12 months of first dose of xaluritamig with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement more than 6 months prior to first dose of xaluritamig.
• Requirement for chronic systemic corticosteroid therapy unless stopped (with adequate tapering) within 7 days prior to dosing.
• Currently receiving treatment in another investigational device or drug study, or less than 4 weeks (since ending treatment on another investigational device or drug study[ies]). Other investigational procedures and participation in observational research studies while participating in this study are excluded with the exception of investigational scans.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A - Xaluritamig; Xaluritamig will be administered prior to radical prostatectomy.	Drug: Xaluritamig; Intravenous (IV) infusion; Other Names: AMG 509
Experimental: Cohort B - Xaluritamig with an Oral GnRH Antagonist; Xaluritamig will be administered prior to radical prostatectomy. Participants will also receive an oral GnRH antagonist continuously up to the time of planned radical prostatectomy.	Drug: Xaluritamig; Intravenous (IV) infusion; Other Names: AMG 509; Drug: GnRH Antagonist; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who Experienced Treatment-emergent Adverse Events	Inclusive of adverse events, serious adverse events, and changes in vital signs and clinical laboratory tests.	Up to 45 months
Number of Participants who Experienced Treatment-related Adverse Events		Up to 28 months
Number of Participants who Received Radical Prostatectomy After Completing Xaluritamig Treatment		Up to 25 months
Number of Participants who Experienced Complications of Radical Prostatectomy According to Clavien-Dindo Classification		Up to 28 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Prostate-specific Antigen (PSA) Levels from Baseline to End of Xaluritamig Treatment	Up to 25 months
Prostate Imaging-Reporting and Data System (PI-RADS) Score	Up to 25 months
Pathological Complete Response (pCR) Following Radical Prostatectomy	Up to 25 months
Minimal Residual Disease (MRD)	Up to 25 months
Number of Participants who Rise to PSA ≥ 0.2 ng/mL Post-radical Prostatectomy	Up to 45 months
Time to PSA Rise ≥ 0.2 ng/mL Post-radical Prostatectomy	Up to 45 months
Undetectable PSA at SFU	Up to 26 months
PSA Progression-free Survival	Up to 45 months
Maximum Serum Concentration (Cmax) of Xaluritamig	Up to 45 months
Time to Maximum Concentration (Tmax) of Xaluritamig	Up to 45 months
Area Under the Concentration Time Curve (AUC) Over the Dosing Interval	Up to 45 months
Accumulation Following Multiple Dosing	Up to 45 months
Half-life (t1/2) of Xaluritamig	Up to 45 months

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): November 25, 2024
• Primary Completion (Estimated): January 22, 2027
• Study Completion (Estimated): January 23, 2030

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Prostate Cancer; Neoadjuvant Therapy; STEAP1; Localized Prostate Cancer; Xaluritamig; T-Cell Engager; AMG509
• 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; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-
• Other Study ID Numbers: 20230237; 2024-511965-13 (Other Identifier: EU CT Number)

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 study will be considered beginning 18 months after the study 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 study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies 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.
• 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