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Clinical Trials in the UK / NCT06691984
Active, not recruiting Phase 3

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

NCT06691984 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2024-12-09
Last updated
2026-05-15

Condition(s) studied

Metastatic Castration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

XaluritamigAbirateroneEnzalutamideCabazitaxel

Xaluritamig: Short-term IV infusion

Abiraterone: Oral tablets

Enzalutamide: Oral tablets

Cabazitaxel: IV infusion

Study summary

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 \[ARDT\]).

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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. * Life expectancy of ≥ 12 weeks per the treating physician's assessment. Key Exclusion Criteria: 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 receptor pathway inhibitors (ARPIs) (abiraterone, enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment and 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.

Primary outcome measure(s)

Trial sites (164)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
City of Hope National Medical Center Duarte California
Providence Saint Jude Medical Center Fullerton California
Cedars Sinai Medical Center Los Angeles California
University of California Irvine Orange California
University of California San Francisco San Francisco California
University of Florida, College of Medicine Gainesville Florida
Sylvester Comprehensive Cancer Center-Fox Building Miami Florida
AdventHealth Orlando Orlando Florida
University of Chicago Chicago Illinois
Indiana University Indianapolis Indiana
University of Louisville Health - James Graham Brown Cancer Center Louisville Kentucky
Norton Cancer Institute Louisville Kentucky
Massachusetts General Hospital Boston Massachusetts
Beth Israel Deaconess Medical Center Boston Massachusetts
Dana-Farber Cancer Institute Boston Massachusetts
Henry Ford Hospital, Henry Ford Health Systems Detroit Michigan
University of Minnesota Minneapolis Minnesota
Washington University St Louis Missouri
Yale New Haven Hospital New York New York
Memorial Sloan Kettering Cancer Center New York New York
Montefiore Medical Center The Bronx New York
Levine Cancer Institute Charlotte North Carolina
Duke University Medical Center Duke Cancer Center Durham North Carolina
Sanford Roger Maris Cancer Center Fargo North Dakota
Cleveland Clinic Foundation Cleveland Ohio
The Ohio State University Columbus Ohio
Oregon Health and Science University Portland Oregon
Thomas Jefferson University Hospital Philadelphia Pennsylvania
Fox Chase Cancer Center Philadelphia Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Sanford Oncology Clinic and Pharmacy Sioux Falls South Dakota
Sarah Cannon Research Institute Nashville Tennessee
Tennessee Oncology PLLC Nashville Tennessee
University of Texas Southwestern Medical Center Dallas Texas
University of Texas MD Anderson Cancer Center Houston Texas
Intermountain Medical Center Murray Utah
Virginia Oncology Associates Norfolk Virginia
Fred Hutchinson Cancer Center Seattle Washington
Swedish Medical Center Seattle Washington

+ 124 more sites — see the full list on the official registry below.

On this site

📄 Zytiga (abiraterone) drug profile → 📄 Xtandi (enzalutamide) drug profile →

More Amgen trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06691984 on ClinicalTrials.gov ↗ ← All trials in the UK