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NCT07213674Recruiting

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

Official recordSimplified version

Summary

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).

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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 3
Study type
Interventional
Countries
Switzerland, France, Germany, Italy, Austria, United States, Australia, Belgium, Canada, Greece, Japan, Netherlands, Portugal, Singapore, South Korea, Spain, Taiwan, United Kingdom
Sponsor
Amgen(Industry)
Protocol no.
20230239
Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
Drug

Treatments studied

  • Xaluritamig
  • Abiraterone acetate
  • Docetaxel
  • Cabazitaxel

Locations · 154

  • Bern, SwitzerlandInselspital BernRecruiting at this site
  • Lausanne, SwitzerlandCentre Hospitalier Universitaire VaudoisRecruiting at this site
  • Sankt Gallen, SwitzerlandKantonsspital Sankt GallenRecruiting at this site
  • Zurich, SwitzerlandHirslanden ZurichRecruiting at this site
  • Bordeaux, FranceCentre Hospitalier Universitaire de Bordeaux - Hopital Saint AndreRecruiting at this site
  • Bordeaux, FranceInstitut BergonieRecruiting at this site
  • Caen, FranceCentre Regional Francois BaclesseRecruiting at this site
  • Clermont-Ferrand, FranceCentre Jean PerrinRecruiting at this site
  • Le Mans, FranceClinique Victor Hugo - Centre Jean BernardRecruiting at this site
  • Lyon, FranceCentre Leon BerardRecruiting at this site
  • Nice, FranceCentre Antoine LacassagneRecruiting at this site
  • Paris, FranceGroupe Hospitalier Paris Saint JosephRecruiting at this site
  • Paris, FranceHopital Europeen Georges PompidouRecruiting at this site
  • Strasbourg, FranceCentre Hospitalier Universitaire de Strasbourg - Hopital de HautepierreRecruiting at this site
  • Suresnes, FranceHopital FochRecruiting at this site
  • Toulouse, FranceInstitut Universitaire du Cancer Toulouse OncopoleRecruiting at this site
  • Vandœuvre-lès-Nancy, FranceInstitut de Cancerologie de LorraineRecruiting at this site
  • Villejuif, FranceGustave RoussyRecruiting at this site
  • Berlin, GermanyCharite - Universitaetsmedizin Berlin, Campus MitteRecruiting at this site
  • Bonn, GermanyUniversitaetsklinikum BonnRecruiting at this site
  • Dresden, GermanyUniversitaetsklinikum DresdenRecruiting at this site
  • Erlangen, GermanyUniklinikum ErlangenRecruiting at this site
  • Essen, GermanyUniversitaetsklinikum EssenRecruiting at this site
  • Hamburg, GermanyUniversitaetsklinikum Hamburg EppendorfRecruiting at this site
  • Heidelberg, GermanyUniversitaetsklinikum HeidelbergRecruiting at this site
  • Jena, GermanyUniversitaetsklinikum JenaRecruiting at this site
  • Kiel, GermanyUniversitaetsklinikum Schleswig-Holstein - KielRecruiting at this site
  • Ulm, GermanyUniversitaetsklinikum UlmRecruiting at this site
  • Würzburg, GermanyUniversitaetsklinikum WuerzburgRecruiting at this site
  • Foggia, ItalyAzienda Ospedaliero Universitaria Ospedali Riuniti di FoggiaRecruiting at this site

In total, worldwide, 154 of the 159 sites listed in the registry are recruiting; the other 5 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 20, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 124 more locations

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.