Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androg… (NCT07140900) | Clinical Trial Compass
RecruitingPhase 1
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
United States60 participantsStarted 2025-10-07
Plain-language summary
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Participants must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
* Participants must have at the time of diagnosis:
* De novo mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer AND started androgen deprivation therapy (ADT) (luteinising hormone-releasing hormone \[LHRH\] agonist/antagonist or orchiectomy) with or without androgen receptor pathway inhibitor (ARPI) (defined as abiraterone OR darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening. Prior docetaxel treatment is not permitted.
* Participants must have at the time of diagnosis:
* High-volume metastatic disease defined as presence of visceral metastasis and/or ≥ 4 bone metastases with at least one outside of the vertebral column and pelvis.
* Documented metastatic disease either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan.
* PSA not progressing per PCWG3 following the initial PSA nadir after starting ADT.
Exclusion Criteria:
* Prior history of central nervous system (CNS) metastases.
* Unresolved toxicities from prior anti-tumor therapy (excluding those related to ongoing ADT and ARPI) not having resolved to Common Terminology Cr…
What they're measuring
1
Number of Participants with Treatment-emergent Adverse Events
Timeframe: Up to approximately 2.5 years
2
Number of Participants with Treatment-related Adverse Events
Timeframe: Up to approximately 2.5 years
3
Number of Participants with Clinically Significant Changes in Vital Signs
Timeframe: Up to approximately 2.5 years
4
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests