Status:
RECRUITING
Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
Lead Sponsor:
Amgen
Conditions:
Prostate Cancer
High-risk Biochemical Recurrence
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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-sensiti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 21 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06555796
Start Date
September 23 2024
End Date
June 21 2029
Last Update
October 30 2025
Active Locations (11)
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1
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States, 55455
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
4
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204