A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Trial Status: active
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).
Inclusion 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07213674.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - Tucson
Status: Active
Name Not AvailableCalifornia
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not AvailableIrvine
City of Hope at Irvine Lennar
Status: Active
Contact: Tanya Barauskas Dorff
Phone: 626-218-6218
Email: tdorff@coh.org
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Name Not AvailableSan Francisco
University of California San Francisco
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Colorado
Aurora
UCHealth University of Colorado Hospital
Status: Approved
Name Not AvailableFlorida
Tampa
Moffitt Cancer Center
Status: Active
Name Not AvailableKansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not AvailableMaryland
Baltimore
University of Maryland/Greenebaum Cancer Center
Status: Active
Contact: Dawn M Barth
Phone: 410-328-7856
Email: dawn.barth@umm.edu
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not AvailableMichigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Active
Name Not AvailableMinnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Active
Name Not AvailableNew York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableOhio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not AvailablePennsylvania
Pittsburgh
UPMC Hillman Cancer Center
Status: Active
Name Not AvailableTexas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not AvailableVirginia
Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationAmgen, Inc.
- Primary ID20230239
- Secondary IDsNCI-2025-07528
- ClinicalTrials.gov IDNCT07213674