RECRUITING

Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

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Conditions

Prostate CancerXaluritamigAMG509Localized Prostate CancerNeoadjuvant TherapyImmunotherapyT-Cell EngagerSTEAP1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-25
Study Completion:2030-01-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06613100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants planned to undergo radical prostatectomy.
  2. * 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:
  3. * Gleason score of 4+3 or higher AND initial PSA (iPSA) \>10 OR
  4. * Clinically advanced (cT3) on Magnetic Resonance Imaging (MRI) obtained within 3 months prior to screening AND/OR
  5. * 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.
  6. * 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).
  7. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  1. * Prior treatment for participant's prostate cancer.
  2. * Any evidence of metastases outside of the surgical resection field identified by conventional imaging or PSMA-PET scans.
  3. * Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
  4. * 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:
  5. * 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.
  6. * 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.
  7. * Requirement for chronic systemic corticosteroid therapy unless stopped (with adequate tapering) within 7 days prior to dosing.
  8. * 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.

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

University of California San Francisco
San Francisco, California, 94143
United States
Washington University
St Louis, Missouri, 63110
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109-1023
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-25
Study Completion Date2030-01-23

Study Record Updates

Study Start Date2024-11-25
Study Completion Date2030-01-23

Terms related to this study

Keywords Provided by Researchers

  • Xaluritamig
  • AMG509
  • Localized Prostate Cancer
  • Prostate Cancer
  • Neoadjuvant Therapy
  • Immunotherapy
  • T-Cell Engager
  • STEAP1

Additional Relevant MeSH Terms

  • Prostate Cancer