Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)
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)
Overall Survival (OS) — Up to approximately 53 months
Trial sites (164)
Facility
City
Region
Status
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.
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.
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