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Clinical Trials in the UK / NCT07213674
Recruiting Phase 3

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

NCT07213674 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2025-11-28
Last updated
2026-09-11

Condition(s) studied

Metastatic Castration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

XaluritamigAbiraterone acetateDocetaxelCabazitaxel

Xaluritamig: Xaluritamig will be administered IV.

Abiraterone acetate: Abiraterone acetate will be administered orally.

Docetaxel: Docetaxel will be administered IV.

Cabazitaxel: Cabazitaxel will be administered IV.

Study summary

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).

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (155)

FacilityCityRegionStatus
City of Hope Cancer Center Phoenix Goodyear Arizona Recruiting
University of Arizona Cancer Center Tucson Arizona Recruiting
City of Hope National Medical Center Duarte California Recruiting
City of Hope Orange County Lennar Foundation Cancer Center Duarte California Recruiting
Providence Saint Jude Medical Center Fullerton California Recruiting
University of California Irvine Orange California Recruiting
University of California San Francisco San Francisco California Recruiting
Providence Saint Johns Health Center Santa Monica California Recruiting
Rocky Mountain Cancer Centers Denver Colorado Recruiting
Hartford HealthCare Cancer Institute at Hartford Hospital Hartford Connecticut Recruiting
Medical Oncology Hematology Consultants Helen F Graham Cancer Center Newark Delaware Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
City of Hope Atlanta Newnan Georgia Recruiting
University of Illinois Chicago Chicago Illinois Recruiting
Cancer Care Specialists of Illinois Decatur Illinois Recruiting
Midwestern Regional Medical Center dba City of Hope Chicago Zion Illinois Recruiting
University of Kansas Medical Center Westwood Kansas Recruiting
University of Louisville Health - James Graham Brown Cancer Center Louisville Kentucky Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
University of Maryland Greenebaum Cancer Center Baltimore Maryland Recruiting
Johns Hopkins Hospital Sidney Kimmell Comprehensive Cancer Center Baltimore Maryland Recruiting
Barbara Ann Karmanos Cancer Institute Lansing Michigan Recruiting
Minnesota Oncology Hematology PA Minneapolis Minnesota Recruiting
University of Minnesota Medical Center Fairview Minneapolis Minnesota Recruiting
Hematology Oncology Association of Central New York East Syracuse New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Oncology Hematology Care Incorporated Cincinnati Ohio Recruiting
The Ohio State University Columbus Ohio Recruiting
Dayton Physicians LLC Dayton Dayton Ohio Recruiting
Hightower Clinical Oklahoma City Oklahoma Recruiting
Oregon Oncology Specialists Salem Oregon Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
South Texas Accelerated Research Therapeutics - Carolinas Myrtle Beach South Carolina Recruiting
Sarah Cannon Research Institute Oncology Partners Nashville Tennessee Recruiting
United States Oncology Regulatory Affairs Corporate Office Nashville Tennessee Recruiting
The Center for Cancer and Blood Disorders Arlington Texas Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Renovatio Clinical Houston Texas Recruiting
Texas Oncology - Northeast Texas Tyler Texas Recruiting
US Oncology Research Investigational Products Center Tyler Texas Recruiting

+ 115 more sites — see the full list on the official registry below.

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 NCT07213674 on ClinicalTrials.gov ↗ ← All trials in the UK