Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitiv… (NCT06555796) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
United States50 participantsStarted 2024-09-23
Plain-language 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).
Who can participate
Age range18 Years
SexMALE
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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 hormon…
What they're measuring
1
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 2 years
2
Number of Participants Experiencing Treatment-related Adverse Events (TRAEs)