Informations générales (source: ClinicalTrials.gov)
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Interventional
Phase 3
Amgen (Voir sur ClinicalTrials)
novembre 2025
août 2032
12 mai 2026
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Ronan FLIPPOT | 07/05/2026 07:45:06 | Contacter | ||
Critères
Homme
- 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.