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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests xaluritamig alone or with an oral hormone-blocking drug before surgery to remove the prostate. It is for people with intermediate- or high-risk prostate cancer who plan to have this surgery. Researchers will check the drugs' safety and whether surgery can be done safely afterward.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You plan to have surgery to remove your prostate.
  • A biopsy confirmed prostate adenocarcinoma, a type of prostate cancer, without neuroendocrine, signet cell, or small cell features.
  • Your cancer meets at least one risk rule: a Gleason score of 4+3 or higher (a cancer grade) plus an initial PSA blood test above 10; cancer at stage cT3 on an MRI from the past 3 months; or nearby lymph nodes with cancer on a PSMA-PET scan, or 5 or fewer local lymph nodes on MRI.
  • You had a PSMA-PET scan, which looks for prostate cancer, as part of your usual care within 3 months before screening.
  • You can do all your usual activities, or you can walk and do light work but have trouble with hard physical activity.

Who can't join

  • You already had treatment for this prostate cancer. For study group B, an oral hormone-blocking drug called a GnRH antagonist is allowed for up to 3 months before screening.
  • Scans show cancer spread outside the area that surgery will remove.
  • You have or had an autoimmune disease, where the immune system attacks the body, or a disease that permanently weakens your immune system or needs lifelong immune-suppressing treatment.
  • You have signs of a sudden or uncontrolled infection affecting your body within 7 days before treatment. If you need antibiotics for an active infection, you may qualify after finishing them and your symptoms clear.
  • You had a clot in an artery, such as a stroke or mini-stroke, within 6 months, or a clot in a vein or lung within 3 months before treatment. People with past vein clots must be on a stable blood thinner plan.
  • You had a heart attack or heart failure with symptoms within 12 months before xaluritamig. An exception allows certain heart attacks or reduced heart blood flow controlled by a stent placed more than 6 months before treatment.
  • You need ongoing steroid medicine that affects the whole body, unless it is stopped with a safe dose reduction within 7 days before treatment.
  • You are in another study testing a drug or device, or finished its treatment less than 4 weeks ago. Other research procedures and observation-only studies are also not allowed during this study, except research scans.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (7)

CA

MO

OH

PA

SC

WA

WI