Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Amgen (Voir sur ClinicalTrials)
décembre 2024
mai 2030
06 août 2025
The main objective of the study is to compare overall survival in participants receiving
xaluritamig versus investigator's choice (cabazitaxel or second androgen
receptor-directed therapy [ARDT]).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice cedex 2 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon - 38700 - La Tronche - France | Contact (sur clinicalTrials) | ||||
| Clinique Victor Hugo - Centre Jean Bernard - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Institut Universitaire du Cancer Toulouse Oncopole - 31059 - Toulouse cedex 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
Inclusion Criteria:
- Participant has provided informed consent prior to 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.
- 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
prior to enrollment.
- Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
- Serum PSA progression defined as 2 consecutive increases in PSA over a previous
reference value measured at least 1 week prior. The minimal 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 one 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
lesion(s) by bone scan (as per the 2+2 PCWG3 criteria).
- Participants must have had a prior orchiectomy and/or ongoing androgen-deprivation
therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
- Prior progression on at least one ARDT (enzalutamide, abiraterone, apalutamide,
darolutamide).
- Prior treatment with only one taxane therapy in the mCRPC setting. Note: Prior
treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC)
setting is permitted; however, participants 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.
Key
- Participant has provided informed consent prior to 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.
- 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
prior to enrollment.
- Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
- Serum PSA progression defined as 2 consecutive increases in PSA over a previous
reference value measured at least 1 week prior. The minimal 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 one 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
lesion(s) by bone scan (as per the 2+2 PCWG3 criteria).
- Participants must have had a prior orchiectomy and/or ongoing androgen-deprivation
therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
- Prior progression on at least one ARDT (enzalutamide, abiraterone, apalutamide,
darolutamide).
- Prior treatment with only one taxane therapy in the mCRPC setting. Note: Prior
treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC)
setting is permitted; however, participants 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.
Key
Prior & Concomitant Therapy:
- Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted
therapy.
- Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior
to the first dose of study treatment, not including androgen suppression therapy
(eg, luteinizing hormone-releasing hormone/gonadotropin-releasing hormone
[LHRH/GnRH] analogue [agonist/antagonist]).
- Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 3
months of the first dose of study treatment unless participants received < 2 cycles
of therapy.
- Prior palliative radiotherapy within 2 weeks of first dose of study treatment.
Participants 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.
- Prior radionuclide therapy (Radium-223) within 2 months of first dose of study
treatment.
- Treatment with live and live-attenuated vaccines within 4 weeks before the first
dose of study treatment.
Disease Related:
- Participants with a history of central nervous system (CNS) metastasis. Note:
Participants with treated, asymptomatic, and clinically stable dural metastases are
eligible.
- Unresolved toxicities from prior anti-tumor therapy not having resolved to CTCAE
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.