NCT07213674Recrutement en cours
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Résumé
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).
Critères d'inclusion
• 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.
Critères d'exclusion
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.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 3
- Type d'étude
- Interventionnelle
- Pays
- Suisse, France, Allemagne, Italie, Autriche, États-Unis, Australie, Belgique, Canada, Grèce, Japon, Pays-Bas, Portugal, Singapour, Corée du Sud, Espagne, Taïwan, Royaume-Uni
- Promoteur
- Amgen(Industrie)
- N° de protocole
- 20230239
- Pathologies
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Médicament
Traitements évalués
- Xaluritamig
- Abiraterone acetate
- Docetaxel
- Cabazitaxel
Lieux · 154
- Bern, SuisseInselspital BernRecrute dans ce centre
- Lausanne, SuisseCentre Hospitalier Universitaire VaudoisRecrute dans ce centre
- Sankt Gallen, SuisseKantonsspital Sankt GallenRecrute dans ce centre
- Zurich, SuisseHirslanden ZurichRecrute dans ce centre
- Bordeaux, FranceCentre Hospitalier Universitaire de Bordeaux - Hopital Saint AndreRecrute dans ce centre
- Bordeaux, FranceInstitut BergonieRecrute dans ce centre
- Caen, FranceCentre Regional Francois BaclesseRecrute dans ce centre
- Clermont-Ferrand, FranceCentre Jean PerrinRecrute dans ce centre
- Le Mans, FranceClinique Victor Hugo - Centre Jean BernardRecrute dans ce centre
- Lyon, FranceCentre Leon BerardRecrute dans ce centre
- Nice, FranceCentre Antoine LacassagneRecrute dans ce centre
- Paris, FranceGroupe Hospitalier Paris Saint JosephRecrute dans ce centre
- Paris, FranceHopital Europeen Georges PompidouRecrute dans ce centre
- Strasbourg, FranceCentre Hospitalier Universitaire de Strasbourg - Hopital de HautepierreRecrute dans ce centre
- Suresnes, FranceHopital FochRecrute dans ce centre
- Toulouse, FranceInstitut Universitaire du Cancer Toulouse OncopoleRecrute dans ce centre
- Vandœuvre-lès-Nancy, FranceInstitut de Cancerologie de LorraineRecrute dans ce centre
- Villejuif, FranceGustave RoussyRecrute dans ce centre
- Berlin, AllemagneCharite - Universitaetsmedizin Berlin, Campus MitteRecrute dans ce centre
- Bonn, AllemagneUniversitaetsklinikum BonnRecrute dans ce centre
- Dresden, AllemagneUniversitaetsklinikum DresdenRecrute dans ce centre
- Erlangen, AllemagneUniklinikum ErlangenRecrute dans ce centre
- Essen, AllemagneUniversitaetsklinikum EssenRecrute dans ce centre
- Hamburg, AllemagneUniversitaetsklinikum Hamburg EppendorfRecrute dans ce centre
- Heidelberg, AllemagneUniversitaetsklinikum HeidelbergRecrute dans ce centre
- Jena, AllemagneUniversitaetsklinikum JenaRecrute dans ce centre
- Kiel, AllemagneUniversitaetsklinikum Schleswig-Holstein - KielRecrute dans ce centre
- Ulm, AllemagneUniversitaetsklinikum UlmRecrute dans ce centre
- Würzburg, AllemagneUniversitaetsklinikum WuerzburgRecrute dans ce centre
- Foggia, ItalieAzienda Ospedaliero Universitaria Ospedali Riuniti di FoggiaRecrute dans ce centre
Au total, dans le monde, 154 des 159 centres listés au registre recrutent ; les 5 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 20 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 124 autres lieux
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Autres versions
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