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

May 14, 2026 updated by: Amgen

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

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]).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

707

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris OBrien Lifehouse
      • North Ryde, New South Wales, Australia, 2109
        • Macquarie University
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Austria
      • Graz, Austria, 8036
        • Medizinische Universitaet Graz
      • Innsbruck, Austria, 6020
        • Medizinische Universitaet Innsbruck
      • Linz, Austria, 4010
        • Ordensklinikum Linz Elisabethinen
      • Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg
      • Sankt Pölten, Austria, 3100
        • Universitaetsklinikum Sankt Poelten
      • Vienna, Austria, 1090
        • Universitaetsklinikum Allgemeines Krankenhaus Wien
      • Vienna, Austria, 1020
        • Krankenhaus der Barmherzigen Brueder Wien
  • Belgium
      • Brussels, Belgium, 1200
        • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Kortrijk, Belgium, 8500
        • Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Vancouver
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Sir Mortimer B Davis - Jewish General Hospital
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec-Universite Laval
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital
      • Vejle, Denmark, 7100
        • Vejle Sygehus
  • France
      • Bordeaux, France, 33075
        • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • La Tronche, France, 38700
        • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
      • Le Mans, France, 72000
        • Clinique Victor Hugo - Centre Jean Bernard
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Marseille, France, 13009
        • Institut Paoli Calmettes
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Saint-Mandé, France, 94163
        • Hopital d Instruction des Armees - Hopital Begin
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Villejuif, France, 94805
        • Gustave Roussy
  • Germany
      • Berlin, Germany, 10117
        • Charite - Universitaetsmedizin Berlin, Campus Mitte
      • Dresden, Germany, 01307
        • Universitaetsklinikum Dresden
      • Düsseldorf, Germany, 40225
        • Universitaetsklinikum Duesseldorf
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Jena, Germany, 07747
        • Universitaetsklinikum Jena
      • Lübeck, Germany, 23538
        • Universitaetsklinikum Schleswig-Holstein - Luebeck
      • München, Germany, 81675
        • Klinikum rechts der Isar der TUM
      • Münster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Würzburg, Germany, 97078
        • Universitaetsklinikum Wuerzburg
  • Greece
      • Athens, Greece, 18547
        • Metropolitan Hospital
      • Athens, Greece, 11528
        • Alexandra Hospital
      • Athens, Greece, 15562
        • Metropolitan General
      • Athens, Greece, 15125
        • Athens Medical Center S.A - Iatriko Amarousiou
      • Thessaloniki, Greece, 57001
        • European Interbalkan Medical Center
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital, The University of Hong Kong
  • Italy
      • Foggia, Italy, 71122
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
      • Gallipoli, Italy, 73014
        • Ospedale Sacro Cuore di Gesù Azienda Sanitaria Locale di Lecce
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino IRCCS
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Orbassano, Italy, 10043
        • Azienda Ospedaliera Universitaria San Luigi Gonzaga
      • Trento, Italy, 38122
        • Ospedale Santa Chiara Azienda Sanitaria Universitaria Integrata del Trentino
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Nagoya University Hospital
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
    • Osaka
      • Osaka, Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Suita-shi, Osaka, Japan, 565-0871
        • The University of Osaka Hospital
    • Saitama
      • Hidaka-shi, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Koshigaya-shi, Saitama, Japan, 343-8555
        • Dokkyo Medical University Saitama Medical Center
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of Japanese Foundation For Cancer Research
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
      • Delft, Netherlands, 2625 AD
        • Reinier de Graaf Gasthuis
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Nijmegen, Netherlands, 6525 GA
        • Radboud Universitair Medisch Centrum
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum
  • Poland
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 31-501
        • SPZOZ Szpital Uniwersytecki w Krakowie
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 168583
        • National Cancer Centre Singapore
  • South Korea
      • Daejeon, South Korea, 35015
        • Chungnam National University Hospital
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08908
        • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
    • Andalusia
      • Málaga, Andalusia, Spain, 29011
        • Hospital Regional Universitario de Málaga
      • Seville, Andalusia, Spain, 41013
        • Hospital Universitario Virgen del Rocío
    • Catalonia
      • Barcelona, Catalonia, Spain, 08041
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Catalonia, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Catalonia, Spain, 08035
        • Hospital Universitari Vall D Hebron
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra
    • Valencia
      • Valencia, Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset
      • Lund, Sweden, 221 85
        • Skånes universitetssjukhus
      • Stockholm, Sweden, 171 76
        • Karolinska Universitetssjukhuset
      • Umeå, Sweden, 901 85
        • Norrlands universitetssjukhus
  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Istituto oncologico della Svizzera italiana
      • Bern, Switzerland, 3010
        • Inselspital Bern
      • Chur, Switzerland, 7000
        • Kantonsspital Graubuenden
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois
      • Sankt Gallen, Switzerland, 9007
        • Kantonsspital Sankt Gallen
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06620
        • Ankara Universitesi Tip Fakultesi Hastanesi
      • Istanbul, Turkey (Türkiye), 34214
        • Bagcilar Medipol Mega Universite Hastanesi
      • Izmir, Turkey (Türkiye), 35575
        • Izmir Ekonomi Universitesi Medical Point Hastanesi
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK
      • London, United Kingdom, NW1 2PG
        • University College London Hospital
      • London, United Kingdom, SE1 9RY
        • Guys Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Fullerton, California, United States, 92835
        • Providence Saint Jude Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Orange, California, United States, 92868
        • University of California Irvine
      • San Francisco, California, United States, 94158
        • University of California San Francisco
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida, College of Medicine
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center-Fox Building
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Health - James Graham Brown Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital, Henry Ford Health Systems
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10032
        • Yale New Haven Hospital
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center Duke Cancer Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Oncology Clinic and Pharmacy
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology PLLC
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
      • Seattle, Washington, United States, 98019-1024
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Carbone Cancer Center
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xaluritamig
Participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion.
Drug: Xaluritamig
Short-term IV infusion
Active Comparator: Cabazitaxel/Abiraterone/Enzalutamide
Participants with mCRPC will be randomized to receive cabazitaxel as an IV infusion, or a second androgen receptor-directed therapy of either abiraterone as oral tablets, or enzalutamide as oral tablets at the investigator's discretion.
Drug: Abiraterone
Oral tablets
Drug: Enzalutamide
Oral tablets
Drug: Cabazitaxel
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 53 months
Up to approximately 53 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Objective Response Rate per Modified RECIST v1.1 as Assessed by BICR
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Duration of Response (DOR) per Modified RECIST v1.1 as Assessed by BICR
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Disease Control Rate per Modified RECIST v1.1 as Assessed by BICR
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Time to Response (TTR) per Modified RECIST v1.1 as Assessed by BICR
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Time to First Symptomatic Skeletal Events (SSE)
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Change from Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Score
Time Frame: Baseline and approximately 53 months
Baseline and approximately 53 months
Change from Baseline in BPI-SF Pain Intensity Scale Score
Time Frame: Baseline and approximately 53 months
Baseline and approximately 53 months
Change from Baseline in BPI-SF Pain Interference Scale Score
Time Frame: Baseline and approximately 53 months
Baseline and approximately 53 months
Change from baseline in the European Quality of Life 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score
Time Frame: Baseline and approximately 53 months
Baseline and approximately 53 months
Change from baseline in the EQ-5D-5L Visual Analogue Scale (VAS)
Time Frame: Baseline and approximately 53 months
Baseline and approximately 53 months
Change from Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score and Subscale Score
Time Frame: Baseline and approximately 53 months
Baseline and approximately 53 months
Time to Worsening in BPI-SF Worst Pain Score
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Time to Worsening in BPI-SF Pain Intensity Scale Score
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Time to Worsening in BPI-SF Pain Interference Scale Score
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Time to Worsening in FACT-P Total Score
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Time to Pain Improvement in Participants with Moderate/Severe Pain at Baseline
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Time to Pain Improvement after Worsening in BPI-SF Pain Intensity Scale Score
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Time to Pain Improvement after Worsening in BPI-SF Pain Interference Scale
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Number of Patient-Reported Symptomatic AEs per Patient-reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Patient-Reported Summary Scores for Overall Bother of Side Effects per FACT-P
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Percentage of Participants Achieving a ≥50% Reduction in Prostate-specific Antigen (PSA) (PSA50)
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Percentage of Participants Achieving a ≥90% Reduction in PSA (PSA90)
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Time to Cmax (Tmax) of Xaluritamig
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Minimum Serum Concentration (Cmin) of Xaluritamig
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Area Under the Concentration-time Curve (AUC) of Xaluritamig
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Accumulation Following Multiple Dosing of Xaluritamig
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Half-life (t1/2) of Xaluritamig
Time Frame: Up to approximately 53 months
Up to approximately 53 months
Number of Participants with Anti-xaluritamig Antibody
Time Frame: Up to approximately 53 months
Up to approximately 53 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2024

Primary Completion (Estimated)

January 2, 2029

Study Completion (Estimated)

July 30, 2029

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230005
  • 2024-513968-25 (Other Identifier: EU CTR Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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