A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
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)
OS — Up to approximately 51 months
Trial sites (155)
Facility
City
Region
Status
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.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.