A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Recruiting · NCT07213674 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
- Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
- Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment.
- Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:
- Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng/mL.
- Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.
- Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria).
- Participants must have had prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
- Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.
- Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate organ function.
Exclusion criteria
- Disease Related:
- Participants with a history of central nervous system (CNS) metastases.
- Unresolved toxicities from prior antitumor therapy not having resolved to 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.
- Prior/Concomitant Therapy:
- Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
- Prior disease progression on or intolerance to abiraterone.
- Prior treatment with any chemotherapy regimen in the mCRPC setting and/or \> 6 cycles of docetaxel treatment in the mHSPC setting.
- Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:
- Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment.
- Androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotrophin releasing hormone \[LHRH/GnRH\] analogue \[agonist/antagonist\]) is permitted.
- Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.
- Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.
- Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.
- Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.
- Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.
- Prior CD3-directed therapy.
Where it is running
60 locations listed across 22 US states.
- City of Hope Cancer Center Phoenix - Goodyear, Arizona, United States
- University of Arizona Cancer Center - Tucson, Arizona, United States
- City of Hope National Medical Center - Duarte, California, United States
- City of Hope Orange County Lennar Foundation Cancer Center - Duarte, California, United States
- Providence Saint Jude Medical Center - Fullerton, California, United States
- University of California Irvine - Orange, California, United States
- University of California San Francisco - San Francisco, California, United States
- Providence Saint Johns Health Center - Santa Monica, California, United States
- Rocky Mountain Cancer Centers - Denver, Colorado, United States
- Hartford HealthCare Cancer Institute at Hartford Hospital - Hartford, Connecticut, United States
- Medical Oncology Hematology Consultants Helen F Graham Cancer Center - Newark, Delaware, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- City of Hope Atlanta - Newnan, Georgia, United States
- University of Illinois Chicago - Chicago, Illinois, United States
- Midwestern Regional Medical Center dba City of Hope Chicago - Zion, Illinois, United States
- University of Kansas Medical Center - Westwood, Kansas, United States
- University of Louisville Health - James Graham Brown Cancer Center - Louisville, Kentucky, United States
- Norton Cancer Institute - Louisville, Kentucky, United States
- University of Maryland Greenebaum Cancer Center - Baltimore, Maryland, United States
- Johns Hopkins Hospital Sidney Kimmell Comprehensive Cancer Center - Baltimore, Maryland, United States
- Barbara Ann Karmanos Cancer Institute - Lansing, Michigan, United States
- Minnesota Oncology Hematology PA - Minneapolis, Minnesota, United States
- University of Minnesota Medical Center Fairview - Minneapolis, Minnesota, United States
- Hematology Oncology Association of Central New York - East Syracuse, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Oncology Hematology Care Incorporated - Cincinnati, Ohio, United States
- The Ohio State University - Columbus, Ohio, United States
- Dayton Physicians LLC Dayton - Dayton, Ohio, United States
- Hightower Clinical - Oklahoma City, Oklahoma, United States
- Oregon Oncology Specialists - Salem, Oregon, United States
- University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania, United States
- South Texas Accelerated Research Therapeutics - Carolinas - Myrtle Beach, South Carolina, United States
- Sarah Cannon Research Institute Oncology Partners - Nashville, Tennessee, United States
- United States Oncology Regulatory Affairs Corporate Office - Nashville, Tennessee, United States
- The Center for Cancer and Blood Disorders - Arlington, Texas, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- Renovatio Clinical - Houston, Texas, United States
- Texas Oncology - Northeast Texas - Tyler, Texas, United States
- US Oncology Research Investigational Products Center - Tyler, Texas, United States
- University of Virginia Cancer Center - Charlottesville, Virginia, United States
- Virginia Cancer Specialists PC - Leesburg, Virginia, United States
- Bon Secours Cancer Institute at Saint Francis - Midlothian, Virginia, United States
- Virginia Oncology Associates - Norfolk, Virginia, United States
- University General Hospital of Alexandroupoli - Alexandroupoli, Greece
- Henry Dunant Hospital Center - Athens, Greece
- Alexandra Hospital - Athens, Greece
- Attikon University Hospital - Athens, Greece
- Hospital Universitari Vall d Hebron - Barcelona, Spain
- Charite - Universitaetsmedizin Berlin, Campus Mitte - Berlin, Germany
- Inselspital Bern - Bern, Switzerland
- Universitaetsklinikum Bonn - Bonn, Germany
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre - Bordeaux, France
- Institut Bergonie - Bordeaux, France
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc - Brussels, Belgium
- Centre Regional Francois Baclesse - Caen, France
- Centre Jean Perrin - Clermont-Ferrand, France
- Universitaetsklinikum Dresden - Dresden, Germany
- Uniklinikum Erlangen - Erlangen, Germany
- Universitaetsklinikum Essen - Essen, Germany
- Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia - Foggia, Italy
Showing 60 of 151 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →