Evaluating a new treatment for localized prostate cancer before surgery

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

This study is testing a new treatment called xaluritamig to see if it can safely help men with localized prostate cancer before they have surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Amgen (Industry-sponsored)
• Locations: 8 sites (San Francisco, California and 7 other locations)
• Trial ID: NCT06613100 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and tolerability of xaluritamig when administered as a neoadjuvant therapy prior to radical prostatectomy in patients with localized prostate cancer. Participants will receive xaluritamig and then undergo surgery to evaluate the feasibility of this approach. The study focuses on patients with intermediate- or high-risk localized prostate cancer, ensuring they meet specific eligibility criteria related to their cancer diagnosis and imaging results.

Who should consider this trial

Good fit: Ideal candidates for this study are men with intermediate- or high-risk localized prostate cancer who are scheduled for radical prostatectomy.

Not a fit: Patients with low-risk prostate cancer or those who do not require surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with localized prostate cancer by enhancing the effectiveness of surgery.

How similar studies have performed: While there have been studies on neoadjuvant therapies for prostate cancer, the specific use of xaluritamig in this context is novel.

Eligibility criteria

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.

Where this trial is running

San Francisco, California and 7 other locations

• University of California San Francisco — San Francisco, California, United States (Recruiting)
• Washington University — St Louis, Missouri, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
• Universitaetsklinikum Essen — Essen, Germany (Recruiting)
• Universitaetsklinikum Hamburg Eppendorf — Hamburg, Germany (Recruiting)

Study contacts

• Study coordinator: Amgen Call Center

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