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
Date de révision : 22/04/2026
Homme
A partir de 18 ans
Date de début de recrutement : 26/06/2025
Date de fin de recrutement : 24/03/2026
Critères :
Critères d'inclusion :
- Subject has provided informed consent(s) prior to initiation of any study specific activities/procedures.
- Prior treatment with only one taxane therapy in mCRPC setting. Note: Prior treatment with docetaxel in the mHSPC setting is permitted; however, subjects 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
- Age equal or greater than 18 years (or equal or greater than legal age within the country if it is older than 18 years) at the time of signing the informed consent
- Subject 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 equal or greater than 1 metastatic lesion that is present on baseline computed tomography, magnetic resonance imaging, or bone scan imaging obtained within 28 days prior to enrollment.
- Evidence of progressive disease, defined as 1 or more PCWG3 criteria
- Subjects must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (less than 50 ng/dL or ;ess than 1.7 nmol/L). This must be assessed locally for eligibility
- Prior progresion on at least one ARDT (enzalutamide, abiraterone, apalutamide, darolutamide)
Critères d'exclusion :
- Prior STEAP1-targeted therapy
- Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to first dose of study treatment, with the following exceptions: - Androgen receptor pathway inhibitors (ARPIs; abiraterone, enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment. - Androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotropin-releasing hormone [LHRH/GnRH] analogue, agonist, or antagonist) is permitted.
- Prior PSMA RLT within 2 months of first dose of study treatment unless subjects received less than 2 cycles of therapy. Subjects who received 1 cycle of PSMA RLT within 35 days prior to first dose of study treatment are also excluded.
- Prior pallative radiotherapy within 2 weeks of first dose of study treatment. Subject 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.
- Patients with a history of central nervous system (CNS) metastasis. Note: Subjects with treated, asymptomatic, and clinically stable dural metastases are eligible.
- Unresolved toxicities from prior anti-tumor therapy with Common Terminology Criteria for Adverse Events 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
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Sites des essais
Adresse
Institut De Cancerologie De L Ouest
49100 Angers France
Centre Hospitalier Regional Et Universitaire De Brest
29200 Brest France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".