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ACTIVE NOT RECRUITING

NCT06691984

PHASE3

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy \[ARDT\]).

Official title: A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

707

Start Date

2024-12-09

Completion Date

2029-07-30

Last Updated

2026-05-15

Healthy Volunteers

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

DRUG

Xaluritamig

Short-term IV infusion

DRUG

Abiraterone

Oral tablets

DRUG

Enzalutamide

Oral tablets

DRUG

Cabazitaxel

IV infusion

Inclusion Criteria: * Participant has provided informed consent prior to 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. * 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 prior to enrollment. * Evidence of progressive disease, defined as 1 or more PCWG3 criteria: * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal 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 one 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 lesion(s) by bone scan (as per the 2+2 PCWG3 criteria). * Participants must have had a prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior progression on at least one ARDT (enzalutamide, abiraterone, apalutamide, darolutamide). * Prior treatment with only one taxane therapy in the mCRPC setting. Note: Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. * Adequate organ function. * Life expectancy of ≥ 12 weeks per the treating physician's assessment. Key Exclusion Criteria: Prior \& Concomitant Therapy: * Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy. * Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to the first dose of study treatment, not including androgen receptor pathway inhibitors (ARPIs) (abiraterone, enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment and androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotropin-releasing hormone \[LHRH/GnRH\] analogue \[agonist/antagonist\]). * Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 3 months of the first dose of study treatment unless participants received \< 2 cycles of therapy. * Prior palliative radiotherapy within 2 weeks of first dose of study treatment. Participants must have recovered from all radiation-related toxicities. * Concurrent cytotoxic chemotherapy, ARDT, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, investigational therapy. Note: Prior treatment with a PARP inhibitor is permitted as long as not within 4 weeks before first dose of study treatment. * Prior radionuclide therapy (Radium-223) within 2 months of first dose of study treatment. * Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment. Disease Related: * Participants with a history of central nervous system (CNS) metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible. * Unresolved toxicities from prior anti-tumor therapy not having resolved to CTCAE version 5.0 events grade above 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.

Locations (164)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope National Medical Center

Duarte, California, United States

Providence Saint Jude Medical Center

Fullerton, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

University of California San Francisco

San Francisco, California, United States

University of Florida, College of Medicine

Gainesville, Florida, United States

Sylvester Comprehensive Cancer Center-Fox Building

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

University of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Louisville Health - James Graham Brown Cancer Center

Louisville, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Hospital, Henry Ford Health Systems

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Yale New Haven Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke University Medical Center Duke Cancer Center

Durham, North Carolina, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Tennessee Oncology PLLC

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Macquarie University

North Ryde, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Medical Centre

Clayton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Medizinische Universitaet Graz

Graz, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Ordensklinikum Linz Elisabethinen

Linz, Austria

Landeskrankenhaus Salzburg

Salzburg, Austria

Universitaetsklinikum Sankt Poelten

Sankt Pölten, Austria

Krankenhaus der Barmherzigen Brueder Wien

Vienna, Austria

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, Austria

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Kortrijk, Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, Belgium

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sir Mortimer B Davis - Jewish General Hospital

Montreal, Quebec, Canada

CHU de Quebec-Universite Laval

Québec, Quebec, Canada

Aarhus University Hospital

Aarhus N, Denmark

Vejle Sygehus

Vejle, Denmark

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre

Bordeaux, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

La Tronche, France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Centre Antoine Lacassagne

Nice, France

Hopital d Instruction des Armees - Hopital Begin

Saint-Mandé, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

Charite - Universitaetsmedizin Berlin, Campus Mitte

Berlin, Germany

Universitaetsklinikum Dresden

Dresden, Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, Germany

Universitaetsklinikum Essen

Essen, Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Jena

Jena, Germany

Universitaetsklinikum Schleswig-Holstein - Luebeck

Lübeck, Germany

Klinikum rechts der Isar der TUM

München, Germany

Universitaetsklinikum Muenster

Münster, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Alexandra Hospital

Athens, Greece

Athens Medical Center S.A - Iatriko Amarousiou

Athens, Greece

Metropolitan General

Athens, Greece

Metropolitan Hospital

Athens, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, Italy

Ospedale Sacro Cuore di Gesù Azienda Sanitaria Locale di Lecce

Gallipoli, Italy

Ospedale Policlinico San Martino IRCCS

Genova, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, Italy

And 64 more locations on ClinicalTrials.gov

Clinical Research Directory

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (164)