Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Conditions
Keywords
Prostate cancer, Xaluritamig
Brief summary
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
Interventions
DRUGXaluritamig
Participants will receive xaluritamig intravenously.
DRUGDarolutamide
Participants will receive darolutamide orally.
DRUGAbiraterone
Participants will receive abiraterone orally.
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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 (synchronous) mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer, AND started ADT (LHRH agonist/antagonist or orchiectomy) with or without 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 or metastases, 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. * No documented PSA progression following the initial PSA nadir after starting ADT.
Exclusion criteria
* Prior history of central nervous system (CNS) metastases. Note: Participants with asymptomatic and clinically stable dural metastases are eligible. * 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 enrolment. * 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 all metastatic sites of disease. Radiotherapy to some sites of metastatic disease for palliation will be permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events | Up to approximately 2.5 years |
| Number of Participants with Treatment-related Adverse Events | Up to approximately 2.5 years |
| Number of Participants with Clinically Significant Changes in Vital Signs | Up to approximately 2.5 years |
| Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests | Up to approximately 2.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Prostate-specific Antigen (PSA) < 0.2 ng/mL at 6 Months | 6 months |
| Time to PSA Progression | Up to approximately 4.5 years |
| Time to First New Systemic Anticancer Therapy | Up to approximately 4.5 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 4.5 years |
| Observed Concentration at the End of a Dose Interval of Darolutamide | Up to approximately 4.5 years |
| Observed Concentration at the End of a Dose Interval of Abiraterone | Up to approximately 4.5 years |
| Maximum Observed Serum Concentration (Cmax) of Xaluritmag | Up to approximately 4.5 years |
| Time to Cmax (Tmax) of Xaluritmag | Up to approximately 4.5 years |
| Area Under the Concentration Time Curve (AUC) of Xaluritmag | Up to approximately 4.5 years |
| Half-life (t1/2) of Xaluritamig | Up to approximately 4.5 years |
Countries
Australia, Switzerland, United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed