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A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

NCT07213674 · Amgen
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Official title
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
About this study
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).
Eligibility criteria
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.
Study design
Enrollment target: 750 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-28
Estimated completion: 2032-08-30
Last updated: 2026-04-16
Interventions
Drug: XaluritamigDrug: Abiraterone acetateDrug: DocetaxelDrug: Cabazitaxel
Primary outcomes
  • OS (Up to approximately 51 months)
Sponsor
Amgen · industry
Contacts & investigators
ContactAmgen Call Center · contact · medinfo@amgen.com · 866-572-6436
InvestigatorMD · study_director, Amgen
All locations (122)
City of Hope Cancer Center PhoenixRecruiting
Goodyear, Arizona, United States
City of Hope National Medical CenterRecruiting
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer CenterRecruiting
Duarte, California, United States
Providence Saint Jude Medical CenterRecruiting
Fullerton, California, United States
Rocky Mountain Cancer CentersRecruiting
Denver, Colorado, United States
Medical Oncology Hematology Consultants Helen F Graham Cancer CenterRecruiting
Newark, Delaware, United States
City of Hope AtlantaRecruiting
Newnan, Georgia, United States
University of Illinois ChicagoRecruiting
Chicago, Illinois, United States
City of Hope ChicagoRecruiting
Zion, Illinois, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
University of Maryland Greenebaum Cancer CenterRecruiting
Baltimore, Maryland, United States
University of Minnesota Medical Center FairviewRecruiting
Minneapolis, Minnesota, United States
Hematology Oncology Association of Central New YorkRecruiting
East Syracuse, New York, United States
Oncology Hematology Care IncorporatedRecruiting
Cincinnati, Ohio, United States
Hightower ClinicalRecruiting
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
United States Oncology Regulatory Affairs Corporate OfficeRecruiting
Nashville, Tennessee, United States
The Center for Cancer and Blood DisordersRecruiting
Arlington, Texas, United States
Texas Oncology Northeast TexasRecruiting
Tyler, Texas, United States
US Oncology Research Investigational Products CenterRecruiting
Tyler, Texas, United States
University of Virginia Cancer CenterRecruiting
Charlottesville, Virginia, United States
Virginia Cancer Specialists PCRecruiting
Leesburg, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Calvary Mater Newcastle HospitalRecruiting
Waratah, New South Wales, Australia
Icon Cancer Care WesleyRecruiting
Herston, Queensland, Australia
Tasman Oncology ResearchRecruiting
Southport, Queensland, Australia
Monash Medical CentreRecruiting
Clayton, Victoria, Australia
Austin Health, Austin HospitalRecruiting
East Melbourne, Victoria, Australia
Ordensklinikum Linz ElisabethinenRecruiting
Linz, Austria
Universitaetsklinikum Sankt PoeltenRecruiting
Sankt Pölten, Austria
Krankenhaus der Barmherzigen Brueder WienRecruiting
Vienna, Austria
Universitaetsklinikum Allgemeines Krankenhaus WienRecruiting
Vienna, Austria
Universite Catholique de Louvain Cliniques Universitaires Saint LucRecruiting
Brussels, Belgium
Universitair Ziekenhuis GentRecruiting
Ghent, Belgium
Universitair Ziekenhuis Leuven - Campus GasthuisbergRecruiting
Leuven, Belgium
Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain NamurRecruiting
Yvoir, Belgium
Sir Mortimer B Davis - Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint AndreRecruiting
Bordeaux, France
Centre Regional Francois BaclesseRecruiting
Caen, France
Centre Jean PerrinRecruiting
Clermont-Ferrand, France
Clinique Victor Hugo - Centre Jean BernardRecruiting
Le Mans, France
Centre Leon BerardRecruiting
Lyon, France
Centre Antoine LacassagneRecruiting
Nice, France
Groupe Hospitalier Paris Saint JosephRecruiting
Paris, France
Hopital Europeen Georges PompidouRecruiting
Paris, France
Hopital FochRecruiting
Suresnes, France
Institut Universitaire du Cancer Toulouse OncopoleRecruiting
Toulouse, France
Gustave RoussyRecruiting
Villejuif, France
Charite - Universitaetsmedizin Berlin, Campus MitteRecruiting
Berlin, Germany
Universitaetsklinikum BonnRecruiting
Bonn, Germany
Universitaetsklinikum DresdenRecruiting
Dresden, Germany
Uniklinikum ErlangenRecruiting
Erlangen, Germany
Universitaetsklinikum EssenRecruiting
Essen, Germany
Universitaetsklinikum Hamburg EppendorfRecruiting
Hamburg, Germany
Universitaetsklinikum HeidelbergRecruiting
Heidelberg, Germany
Universitatsklinikum JenaRecruiting
Jena, Germany
Universitaetsklinikum Schleswig-Holstein - KielRecruiting
Kiel, Germany
Universitaetsklinikum UlmRecruiting
Ulm, Germany
Universitaetsklinikum WuerzburgRecruiting
Würzburg, Germany
University General Hospital of AlexandroupoliRecruiting
Alexandroupoli, Greece
Henry Dunant Hospital CenterRecruiting
Athens, Greece
Alexandra HospitalRecruiting
Athens, Greece
Attikon University HospitalRecruiting
Athens, Greece
University Hospital of HeraklionRecruiting
Heraklion - Crete, Greece
General Oncological Hospital of Kifisia Oi Agioi AnargyroiRecruiting
Kifissia, Athens, Greece
Athens Medical Center S.A - Iatriko AmarousiouRecruiting
Marousi, Greece
European Interbalkan Medical CenterRecruiting
Thessaloniki, Greece
Azienda Ospedaliero Universitaria Ospedali Riuniti di FoggiaRecruiting
Foggia, Italy
IRCCS Ospedale San RaffaeleRecruiting
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
Milan, Italy
Azienda Ospedaliera Universitaria San Luigi GonzagaRecruiting
Orbassano, Italy
Ospedale Pederzoli Casa di Cura PrivataRecruiting
Peschiera del Garda, Italy
IRCCS Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Ospedale Santa Chiara Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di TrentoRecruiting
Trento, Italy
Nagoya University HospitalRecruiting
Nagoya, Aichi-ken, Japan
National Hospital Organization Shikoku Cancer CenterRecruiting
Matsuyama, Ehime, Japan
Kyushu University HospitalRecruiting
Fukuoka, Fukuoka, Japan
Kobe University HospitalRecruiting
Kobe, Hyōgo, Japan
Kanazawa University HospitalRecruiting
Kanazawa, Ishikawa-ken, Japan
Kagawa University HospitalRecruiting
Kita-gun, Kagawa-ken, Japan
Kitasato University HospitalRecruiting
Sagamihara-shi, Kanagawa, Japan
Osaka International Cancer InstituteRecruiting
Osaka, Osaka, Japan
The University of Osaka HospitalRecruiting
Suita-shi, Osaka, Japan
Saitama Medical University International Medical CenterRecruiting
Hidaka-shi, Saitama, Japan
Dokkyo Medical University Saitama Medical CenterRecruiting
Koshigaya-shi, Saitama, Japan
Nippon Medical School HospitalRecruiting
Bunkyo-ku, Tokyo, Japan
The Cancer institute Hospital of Japanese Foundation for Cancer ResearchRecruiting
Koto-ku, Tokyo, Japan
The Jikei University HospitalRecruiting
Minato-ku, Tokyo, Japan
Toyama University HospitalRecruiting
Toyama, Toyama, Japan
Universitair Medisch Centrum GroningenRecruiting
Groningen, Netherlands
Hospital da Luz, SARecruiting
Lisbon, Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa MariaRecruiting
Lisbon, Portugal
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao JoaoRecruiting
Porto, Portugal
Unidade Local de Saude de Gaia-Espinho, EPERecruiting
Vila Nova de Gaia, Portugal
National University HospitalRecruiting
Singapore, Singapore
National Cancer Centre SingaporeRecruiting
Singapore, Singapore
Tan Tock Seng HospitalRecruiting
Singapore, Singapore
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Hospital Clinico Universitario Virgen de la VictoriaRecruiting
Málaga, Andalusia, Spain
Hospital Regional Universitario de MalagaRecruiting
Málaga, Andalusia, Spain
Hospital Universitari Vall d HebronRecruiting
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de BarcelonaRecruiting
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Catalonia, Spain
Complexo Hospitalario Universitario A Coruna Hospital Teresa HerreraRecruiting
A Coruña, Galicia, Spain
Hospital Universitario Lucus AugustiRecruiting
Lugo, Galicia, Spain
Hospital Universitario Puerta de Hierro MajadahondaRecruiting
Majadahonda, Madrid, Spain
Clinica Universidad de NavarraRecruiting
Pamplona, Navarre, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Hospital Clinico San CarlosRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Inselspital BernRecruiting
Bern, Switzerland
Centre Hospitalier Universitaire VaudoisRecruiting
Lausanne, Switzerland
Kantonsspital Sankt GallenRecruiting
Sankt Gallen, Switzerland
Hirslanden ZurichRecruiting
Zurich, Switzerland
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
Guys HospitalRecruiting
London, United Kingdom
Sarah Cannon Research Institute UKRecruiting
London, United Kingdom
Royal Marsden HospitalRecruiting
Sutton, United Kingdom
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer · TrialPath