Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)
Trial Status: active
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]).
Inclusion Criteria
- 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. 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 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.
Additional locations may be listed on ClinicalTrials.gov for NCT06691984.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not AvailableOrange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Name Not AvailableSan Francisco
University of California San Francisco
Status: Approved
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not AvailableMassachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not AvailableBeth Israel Deaconess Medical Center
Status: Active
Name Not AvailableMassachusetts General Hospital Cancer Center
Status: Active
Name Not AvailableBrigham and Women's Hospital
Status: Active
Name Not AvailableMinnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Active
Name Not AvailableMissouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not AvailableNorth Carolina
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Status: Active
Name Not AvailableDurham
Duke University Medical Center
Status: Active
Name Not AvailableOhio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not AvailableColumbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not AvailablePennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not AvailablePittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not AvailableTexas
Houston
M D Anderson Cancer Center
Status: Approved
Name Not AvailableWashington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Approved
Name Not AvailableWisconsin
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationAmgen, Inc.
- Primary ID20230005
- Secondary IDsNCI-2024-09676, 2024-513968-25
- ClinicalTrials.gov IDNCT06691984