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NCT07140900Recrutement en cours

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

Résumé

The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.

Critères d'inclusion

• Participants must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted. • Participants must have at the time of diagnosis: • De novo (synchronous) mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer, AND started ADT (LHRH agonist/antagonist or orchiectomy) with or without ARPI (defined as abiraterone OR darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening. Prior docetaxel treatment is not permitted. • Participants must have at the time of diagnosis: • High-volume metastatic disease defined as presence of visceral metastasis or metastases, and/or ≥ 4 bone metastases with at least one outside of the vertebral column and pelvis. • Documented metastatic disease either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan. • No documented PSA progression following the initial PSA nadir after starting ADT.

Critères d'exclusion

• Prior history of central nervous system (CNS) metastases. Note: Participants with asymptomatic and clinically stable dural metastases are eligible. • Unresolved toxicities from prior anti-tumor therapy (excluding those related to ongoing ADT and ARPI) not having resolved to Common Terminology Criteria for Adverse events (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. • Autoimmune disease requiring systemic immunosuppression within the past 2 years. • Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active or systemic infection within 7 days prior to the first dose of study treatment. • Prior six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy. • Prior radioligand therapy (RLT), poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, cytotoxic chemotherapy, aminoglutethimide or ketoconazole for prostate cancer, or any prior systemic biologic therapy, including immunotherapy for prostate cancer. • Prior enzalutamide or apalutamide within 15 days prior to enrolment. • Requirement for chronic systemic corticosteroid therapy (prednisone dose greater than 10 mg per day or local equivalent) or any other immunosuppressive therapies (including anti TNFα therapies) unless stopped (with adequate tapering) within 7 days prior to dosing. • Prior radiotherapy to all metastatic sites of disease. Radiotherapy to some sites of metastatic disease for palliation will be permitted.

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 1
Type d'étude
Interventionnelle
Pays
Suisse, États-Unis, Australie
Promoteur
Amgen(Industrie)
N° de protocole
20240361
Pathologies
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Interventions
Médicament

Traitements évalués

  • Xaluritamig
  • Darolutamide
  • Abiraterone

Lieux · 16

  • Chur, SuisseKantonsspital GraubuendenRecrute dans ce centre
  • Lausanne, SuisseCentre Hospitalier Universitaire VaudoisRecrute dans ce centre
  • Sankt Gallen, SuisseKantonsspital Sankt GallenRecrute dans ce centre
  • San Francisco, États-UnisUniversity of California San FranciscoRecrute dans ce centre
  • Boston, États-UnisDana Farber Cancer InstituteRecrute dans ce centre
  • Minneapolis, États-UnisUniversity of MinnesotaRecrute dans ce centre
  • Cleveland, États-UnisCleveland Clinic FoundationRecrute dans ce centre
  • Philadelphia, États-UnisThomas Jefferson UniversityRecrute dans ce centre
  • Pittsburgh, États-UnisUniversity of Pittsburgh Medical Center Hillman Cancer CenterRecrute dans ce centre
  • Myrtle Beach, États-UnisSouth Texas Accelerated Research Therapeutics - CarolinasRecrute dans ce centre
  • Nashville, États-UnisSarah Cannon Research InstituteRecrute dans ce centre
  • Camperdown, AustralieChris OBrien LifehouseRecrute dans ce centre
  • Waratah, AustralieCalvary Mater Newcastle HospitalRecrute dans ce centre
  • Clayton, AustralieCabrini HospitalRecrute dans ce centre
  • Melbourne, AustraliePeter MacCallum Cancer CentreRecrute dans ce centre
  • Melbourne, AustralieThe Alfred HospitalRecrute dans ce centre

Au total, dans le monde, les 16 centres listés au registre recrutent.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 2 juillet 2026).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.