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New treatment option for Prostate Cancer
Official title Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
ClinicalTrials.gov ID: NCT06613100
What this study is testing
What is Xaluritamig?
Xaluritamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.
Also referred to as AMG 509.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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...
- Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection...
- Recent history of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis) within 6 and 3...
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- St Louis, Missouri, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Essen, Germany
- Hamburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; St Louis, Missouri, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States; Myrtle Beach, South Carolina, United States; Seattle, Washington, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.