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Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)
EU CTIS ID: 2024-513968-25-00
What this study is testing
To compare overall survival (OS) in subjects receiving xaluritamig vs investigator’s choice (cabazitaxel or second androgen receptor-directed therapy [ARDT])
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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)
What rules you out
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Japan
- Taiwan
- Korea, Republic of
- Canada
- Hong Kong
- Turkey
- United Kingdom
- United States
- Singapore
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Japan; Taiwan; Korea, Republic of; Canada; Hong Kong and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.