Evaluating Xaluritamig for high-risk prostate cancer recurrence
A Phase 1b, Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Subjects With High-risk Biochemical Recurrence of Nonmetastatic Castration-sensitive Prostate Cancer After Definitive Therapy
This study is testing a new immunotherapy called xaluritamig to see if it is safe and helps adults with high-risk prostate cancer that has come back after treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Amgen Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone |
| Locations | 8 sites (Minneapolis, Minnesota and 7 other locations) |
| Trial ID | NCT06555796 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of xaluritamig, an immunotherapy treatment, in adult patients with high-risk biochemical recurrent non-metastatic castration-sensitive prostate cancer. Participants must have a confirmed diagnosis and specific PSA levels indicating recurrence after initial treatment. The study will involve administering xaluritamig to evaluate its effects on this patient population.
Who should consider this trial
Good fit: Ideal candidates are adult males with high-risk biochemical recurrent non-metastatic castration-sensitive prostate cancer who meet specific eligibility criteria.
Not a fit: Patients with neuroendocrine differentiation or those who have not undergone the required imaging studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with high-risk prostate cancer recurrence.
How similar studies have performed: Other studies have shown promise with immunotherapy approaches in prostate cancer, suggesting potential for success with this novel treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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 68Ga-PSMA-11 or a piflufolastat F18 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 prostate-specific membrane antigen (PSMA)-positive lesions in the 68Ga-PSMA-11 or the piflufolastat F18 positron emission tomography (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. * Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. * 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).
Where this trial is running
Minneapolis, Minnesota and 7 other locations
- University of Minnesota Medical Center Fairview — Minneapolis, Minnesota, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Chris OBrien Lifehouse — Camperdown, New South Wales, Australia (Recruiting)
- Cabrini Hospital — Malvern, Victoria, Australia (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.