Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
- Registration Number
- NCT06613100
- Lead Sponsor
- Amgen
- Brief Summary
The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered in the neoadjuvant setting followed by radical prostatectomy and to evaluate the feasibility and safety of a radical prostatectomy following xaluritamig administered in the neoadjuvant setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
Subjects are eligible to be included in the study only if all the following criteria apply:
- Subjects 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 iPSA >10 OR
- Clinically advanced (cT3) on MRI imaging obtained within 3 months prior to screening AND/OR
- Positive locoregional lymph nodes as detected by PSMA-PET scans OR equal or ≤ 5 local lymph nodes on MRI can be enrolled.
- Subjects must have undergone a gallium-68 prostate-specific membrane antigen (68Ga-PSMA-11) or a piflufolastat F 18 PET (CT or MRI) scan within 3 months prior to screening as part of the SOC.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
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Exclusion Criteria
Subjects are excluded from the study if any of the following criteria apply:
- Prior treatment for subject's prostate cancer.
- 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.
- Subject 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:
- Subject has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the subject may be considered eligible for the study from an infection standpoint.
- History of arterial or venous thrombosis or other diseases requiring permanent anticoagulation (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis):
- Patients requiring anticoagulation due to atrial fibrillation may be allowed if they can safely stop the anticoagulation for the perisurgical timeframe.
- 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
- 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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Xaluritamig Xaluritamig Xaluritamig will be administered prior to radical prostatectomy.
- Primary Outcome Measures
Name Time Method Number of Participants who Experienced Treatment-emergent Adverse Events Up to 42 months Inclusive of adverse events, serious adverse events, and changes in vital signs and clinical laboratory tests.
Number of Participants who Experienced Treatment-related Adverse Events Up to 12 weeks post radical prostatectomy (RP) Number of Participants who Received Radical Prostatectomy After Completing Xaluritamig Treatment Up to 4 weeks after completing xaluritamig therapy, a maximum of 12 weeks Number of Participants who Experienced Complications of Radical Prostatectomy According to Clavien-Dindo Classification Up to approximately 90 days after completion of the radical prostatectomy surgery, a maximum of 12 weeks
- Secondary Outcome Measures
Name Time Method Change in Prostate-specific Antigen (PSA) Levels from Baseline to End of Xaluritamig Treatment Up to 42 months Prostate Imaging-Reporting and Data System (PI-RADS) Score Baseline and after 8 weeks of neoadjuvant therapy Pathological Complete Response (pCR) Following Radical Prostatectomy After 8 weeks of neoadjuvant therapy + RP Minimal Residual Disease (MRD) After 8 weeks of neoadjuvant therapy + RP Number of Participants who Rise to PSA ≥ 0.2 ng/mL Post-radical Prostatectomy Up to 42 months Time to PSA Rise ≥ 0.2 ng/mL Post-radical Prostatectomy Up to 42 months Undetectable PSA at SFU 19 weeks Prostate Specific Antigen (PSA)-Free Survival Up to 42 months Maximum Serum Concentration (Cmax) of Xaluritamig Up to 30 days after the last dose of neoadjuvant therapy Time to Maximum Concentration (Tmax) of Xaluritamig Up to 30 days after the last dose of neoadjuvant therapy Area Under the Concentration Time Curve (AUC) Over the Dosing Interval Up to 30 days after the last dose of neoadjuvant therapy Accumulation Following Multiple Dosing Up to 30 days after the last dose of neoadjuvant therapy Half-life (t1/2) of Xaluritamig Up to 30 days after the last dose of neoadjuvant therapy
Trial Locations
- Locations (5)
University of California San Francisco
🇺🇸San Francisco, California, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Universitatsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany