A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
NCT ID: NCT07213674
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
750 participants
INTERVENTIONAL
2025-11-28
2032-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Xaluritamig Plus Abiraterone
Participants will be randomized to receive xaluritamig in combination with abiraterone acetate.
Xaluritamig
Xaluritamig will be administered IV.
Abiraterone acetate
Abiraterone acetate will be administered orally.
Investigator's Choice
Participants will receive investigator's choice of:
* Abiraterone acetate orally, once daily or
* Docetaxel IV Q3W or
* Cabazitaxel IV Q3W.
Abiraterone acetate
Abiraterone acetate will be administered orally.
Docetaxel
Docetaxel will be administered IV.
Cabazitaxel
Cabazitaxel will be administered IV.
Interventions
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Xaluritamig
Xaluritamig will be administered IV.
Abiraterone acetate
Abiraterone acetate will be administered orally.
Docetaxel
Docetaxel will be administered IV.
Cabazitaxel
Cabazitaxel will be administered IV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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, not including 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 first dose of study treatment. Participants who received \< 2 cycles of PSMA RLT within 6 weeks of first dose of study treatment are also excluded.
* 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.
18 Years
MALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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City of Hope National Medical Center
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, United States
University of Illinois Chicago
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
Icon Cancer Care Wesley
Herston, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Universitaetsklinikum Sankt Poelten
Sankt Pölten, , Austria
Krankenhaus der Barmherzigen Brueder Wien
Vienna, , Austria
Universitatsklinikum Jena
Jena, , Germany
Athens Medical Center S.A - Iatriko Amarousiou
Marousi, , Greece
European Interbalkan Medical Center
Thessaloniki, , Greece
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
The Cancer institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, , Portugal
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto, , Portugal
National University Hospital
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Clinico San Carlos
Madrid, , Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, , Switzerland
Hirslanden Zurich
Zurich, , Switzerland
Taichung Veterans General Hospital
Taichung, , Taiwan
Sarah Cannon Research Institute UK
London, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20230239
Identifier Type: -
Identifier Source: org_study_id
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