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

Running, not enrolling · Phase 1

Conditions studied: Prostate Cancer, High-risk Biochemical Recurrence, High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer, Non-metastatic Castration-sensitive Prostate Cancer

In brief

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).

Key facts

Study ID

NCT06555796

Run by

Amgen

People needed

50

Starts

2024-09-23

Expected to finish

2028-12-02

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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