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Looking for participantsPhase3

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

Sponsor: Amgen

NCT ID: NCT07213674

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Xaluritamig (drug), Abiraterone acetate (drug), Docetaxel (drug), Cabazitaxel (drug)
How long the study runs
Study runs about 81 months (dates as stated)
About the drug or intervention
Xaluritamig — drug: Xaluritamig will be administered IV. · Abiraterone acetate — drug: Abiraterone acetate will be administered orally. · Docetaxel — drug: Docetaxel will be administered IV. · Cabazitaxel — drug: Cabazitaxel will be administered IV.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
750
Started
2025-11-28
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic castration-resistant prostate cancer
  • • Phase3 - 750 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with metastatic castration-resistant prostate cancer
  • • Male only

Where?

  • • London - Guys Hospital
  • • London - Sarah Cannon Research Institute UK
  • • Sutton - Royal Marsden Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Metastatic Castration-resistant Prostate Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

Biomarkers mentioned

PSACD3

Treatment history

Treatments you must have had:

  • ✓ histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate

What the study is looking for

  • ✓Participant has provided agreement to take part 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...
  • ✓Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified (standard scan measurements) criteria:
  • ✓Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least...
  • ✓Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2...

Who cannot take part

  • ✗Disease Related:
  • ✗Participants with a history of central nervous system (CNS) metastases.
  • ✗Prior/Concomitant Therapy:
  • ✗Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-treatment that targets specific changes in the cancer.
  • ✗Prior disease progression on or intolerance to abiraterone.
See the full criteria
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.

Where Is This Study? (3 UK sites)

Guys Hospital

London SE1 9RY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Sarah Cannon Research Institute UK

London W1G 6AD, United Kingdom

Recruiting

Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Amgen Call Center

Sponsor contact

CONTACT

866-572-6436 medinfo@amgen.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09