Clinical trial NCT06613100: Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Xaluritamig
AMG509
Localized Prostate Cancer
Prostate Cancer
Neoadjuvant Therapy
Immunotherapy
T-Cell Engager
STEAP1
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-09-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of Participants who Experienced Treatment-emergent Adverse Events
timeFrame: Up to 42 months
measure: Number of Participants who Experienced Treatment-related Adverse Events
timeFrame: Up to 12 weeks post radical prostatectomy (RP)
measure: Number of Participants who Received Radical Prostatectomy After Completing Xaluritamig Treatment
timeFrame: Up to 4 weeks after completing xaluritamig therapy, a maximum of 12 weeks
measure: Number of Participants who Experienced Complications of Radical Prostatectomy According to Clavien-Dindo Classification
timeFrame: Up to approximately 90 days after completion of the radical prostatectomy surgery, a maximum of 12 weeks
Secondary outcomes:
measure: Change in Prostate-specific Antigen (PSA) Levels from Baseline to End of Xaluritamig Treatment
timeFrame: Up to 42 months
measure: Prostate Imaging-Reporting and Data System (PI-RADS) Score
timeFrame: Baseline and after 8 weeks of neoadjuvant therapy
measure: Pathological Complete Response (pCR) Following Radical Prostatectomy
timeFrame: After 8 weeks of neoadjuvant therapy + RP
measure: Minimal Residual Disease (MRD)
timeFrame: After 8 weeks of neoadjuvant therapy + RP
measure: Number of Participants who Rise to PSA ≥ 0.2 ng/mL Post-radical Prostatectomy
timeFrame: Up to 42 months
measure: Time to PSA Rise ≥ 0.2 ng/mL Post-radical Prostatectomy
timeFrame: Up to 42 months
measure: Undetectable PSA at SFU
timeFrame: 19 weeks
measure: Prostate Specific Antigen (PSA)-Free Survival
timeFrame: Up to 42 months
measure: Maximum Serum Concentration (Cmax) of Xaluritamig
timeFrame: Up to 30 days after the last dose of neoadjuvant therapy
measure: Time to Maximum Concentration (Tmax) of Xaluritamig
timeFrame: Up to 30 days after the last dose of neoadjuvant therapy
measure: Area Under the Concentration Time Curve (AUC) Over the Dosing Interval
timeFrame: Up to 30 days after the last dose of neoadjuvant therapy
measure: Accumulation Following Multiple Dosing
timeFrame: Up to 30 days after the last dose of neoadjuvant therapy
measure: Half-life (t1/2) of Xaluritamig
timeFrame: Up to 30 days after the last dose of neoadjuvant therapy
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: