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Clinical Trials in Australia / NCT06555796
Active, not recruiting Phase 1

Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

NCT06555796 · tracked via the Priya Life Science Australia tracker
Sponsor
Phase
Phase 1
Started
2024-09-23
Last updated
2026-09-04

Condition(s) studied

Prostate CancerHigh-risk Biochemical RecurrenceHigh Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate CancerNon-metastatic Castration-sensitive Prostate Cancer

Investigational drug(s) / intervention(s)

Xaluritamig →

Xaluritamig: IV infusion

Study summary

The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. * Prostate cancer initially treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both (eg, salvage radiotherapy), with curative intent. * PSA doubling time ≤ 12 months. * Participants must have biochemically recurrent disease after definitive treatment to prostate by either RP or XRT. * Screening PSA by the local laboratory ≥ 0.2 ng/mL for participants who had RP (with or without XRT) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir (local assessments) for participants who had XRT or brachytherapy only as primary treatment for prostate cancer. * Serum testosterone ≥ 150 ng/dL (5.2 nmol/L). * Participants must have undergone a prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan during or within 3 months of screening. Exclusion Criteria * Present evidence of metastatic disease in conventional CT scan and/or bone scan * Participants that present PSMA-positive lesions in the PSMA PET scan may be enrolled if the conventional imaging does not show suspicion of metastatic disease. * Prior hormonal therapy, exceptions include: * Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before enrollment, or * A single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before enrollment. * Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, enzalutamide, apalutamide, or darolutamide for prostate cancer. * Abiraterone acetate, enzalutamide, apalutamide, or darolutamide are allowed if administered in a neoadjuvant/adjuvant setting ≤ 36 months in duration and ≥ 9 months before enrollment. * Prior systemic biologic therapy, including immunotherapy, for prostate cancer. * If, in the investigator's opinion, salvage therapy is the preferred intervention. * Autoimmune disease requiring systemic immunosuppression within the past 2 years. * Participant 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. * Requirement for chronic systemic corticosteroid therapy (prednisone dose \> 10 mg/day or equivalent) or any other immunosuppressive therapies (including anti tumor necrosis factor alpha \[TNFα\] therapies) unless stopped (with adequate tapering) within 7 days prior to dosing.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
University of Minnesota Medical Center Fairview Minneapolis Minnesota
Memorial Sloan Kettering Cancer Center New York New York
University of North Carolina at Chapel Hill Chapel Hill North Carolina
Levine Cancer Institute Charlotte North Carolina
Oregon Health and Science University Portland Oregon
Thomas Jefferson University Philadelphia Pennsylvania
University of Texas Southwestern Medical Center Dallas Texas
Fred Hutchinson Cancer Center Seattle Washington
Chris OBrien Lifehouse Camperdown New South Wales
Cabrini Hospital Malvern Victoria
Peter MacCallum Cancer Centre Melbourne Victoria

More Amgen trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06555796 on ClinicalTrials.gov ↗ ← All trials in Australia