Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
Not Applicable
Not yet recruiting
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Interventions
- Registration Number
- NCT07140900
- Lead Sponsor
- Amgen
- Brief Summary
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 60
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 Criteria for Adverse events (CTCAE) version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.
- 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 or systemic infection within 7 days prior to the first dose of study treatment.
- Prior six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
- Prior radioligand therapy (RLT), poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, cytotoxic chemotherapy, aminoglutethimide or ketoconazole for prostate cancer, or any prior systemic biologic therapy, including immunotherapy for prostate cancer.
- Prior enzalutamide or apalutamide within 15 days prior to enrollment.
- Requirement for chronic systemic corticosteroid therapy (prednisone dose greater than 10 mg per day or local equivalent) or any other immunosuppressive therapies (including anti TNFα therapies) unless stopped (with adequate tapering) within 7 days prior to dosing.
- Prior radiotherapy (to the prostate and/or to all visible metastatic lesions in a metastasis-directed therapy approach); palliative radiation within 2 weeks prior to first dose of study treatment is allowed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Xaluritamig with Darolutamide Xaluritamig Participants will receive xaluritamig in combination with darolutamide. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first. Xaluritamig with Abiraterone Abiraterone Participants will receive xaluritamig in combination with abiraterone. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first. Xaluritamig with Darolutamide Darolutamide Participants will receive xaluritamig in combination with darolutamide. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first. Xaluritamig with Abiraterone Xaluritamig Participants will receive xaluritamig in combination with abiraterone. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first.
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment-emergent Adverse Events Up to approximately 13 months Number of Participants with Treatment-related Adverse Events Up to approximately 13 months Number of Participants with Clinically Significant Changes in Vital Signs Up to approximately 13 months Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests Up to approximately 13 months
- Secondary Outcome Measures
Name Time Method Time to First New Systemic Anticancer Therapy Up to approximately 3 years Time to Radiographic Progression per Prostate Cancer Working Group 3 (PCWG3) Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Up to approximately 3 years Observed Concentration at the End of a Dose Interval of Darolutamide Up to 12 months Time to Cmax (Tmax) of Xaluritmag Up to 13 months Area Under the Concentration Time Curve (AUC) of Xaluritmag Up to 13 months Percentage of Participants with Prostate-specific Antigen (PSA) < 0.2 ng/mL at 6 Months 6 months Observed Concentration at the End of a Dose Interval of Abiraterone Up to 12 months Maximum Observed Serum Concentration (Cmax) of Xaluritmag Up to 13 months Half-life (t1/2) of Xaluritamig Up to 13 months Time to PSA Progression Up to approximately 3 years