Recruiting
Phase 3

Xaluritamig vs. Abiraterone

Sponsor:

Amgen

Code:

NCT07213674

Conditions

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Xaluritamig

Abiraterone acetate

Docetaxel

Cabazitaxel

Study Details

Brief 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).

Conditions

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT07213674

Start date

Nov 28, 2025

Status verified date

Aug, 2026

Completion date

Aug 30, 2032

Anticipated

Primary completion date

Jan 7, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Xaluritamig Plus Abiraterone

Participants will be randomized to receive xaluritamig in combination with abiraterone acetate.

active comparator: Investigator's Choice

Participants will receive investigator's choice of:

  • Abiraterone acetate orally, once daily or
  • Docetaxel IV Q3W or
  • Cabazitaxel IV Q3W.

Interventions

Xaluritamig

Xaluritamig will be administered IV.

Abiraterone acetate

Abiraterone acetate will be administered orally.

Docetaxel

Docetaxel will be administered IV.

Cabazitaxel

Cabazitaxel will be administered IV.

Primary outcome measure

  • OS [ Time Frame: Up to approximately 51 months ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

City of Hope Cancer Center Phoenix

Recruiting

Goodyear, Arizona, United States, 85338

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85724

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

City of Hope Orange County Lennar Foundation Cancer Center

Recruiting

Duarte, California, United States, 91010

Providence Saint Jude Medical Center

Recruiting

Fullerton, California, United States, 92835

University of California Irvine

Recruiting

Orange, California, United States, 92868

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Providence Saint Johns Health Center

Recruiting

Santa Monica, California, United States, 90404

Rocky Mountain Cancer Centers

Recruiting

Denver, Colorado, United States, 80218

Hartford HealthCare Cancer Institute at Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Medical Oncology Hematology Consultants Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

City of Hope Atlanta

Recruiting

Newnan, Georgia, United States, 30265

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Midwestern Regional Medical Center dba City of Hope Chicago

Recruiting

Zion, Illinois, United States, 60099

University of Kansas Medical Center

Recruiting

Westwood, Kansas, United States, 66205

University of Louisville Health - James Graham Brown Cancer Center

Recruiting

Louisville, Kentucky, United States, 40202

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

University of Maryland Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Johns Hopkins Hospital Sidney Kimmell Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Barbara Ann Karmanos Cancer Institute

Recruiting

Lansing, Michigan, United States, 48910

Minnesota Oncology Hematology PA

Recruiting

Minneapolis, Minnesota, United States, 55404

University of Minnesota Medical Center Fairview

Recruiting

Minneapolis, Minnesota, United States, 55455

Hematology Oncology Association of Central New York

Recruiting

East Syracuse, New York, United States, 13057

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Oncology Hematology Care Incorporated

Recruiting

Cincinnati, Ohio, United States, 45242

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Dayton Physicians LLC Dayton

Recruiting

Dayton, Ohio, United States, 45415

Hightower Clinical

Recruiting

Oklahoma City, Oklahoma, United States, 73102

Oregon Oncology Specialists

Recruiting

Salem, Oregon, United States, 97301

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

South Texas Accelerated Research Therapeutics - Carolinas

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Sarah Cannon Research Institute Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

United States Oncology Regulatory Affairs Corporate Office

Recruiting

Nashville, Tennessee, United States, 37203

The Center for Cancer and Blood Disorders

Recruiting

Arlington, Texas, United States, 76012

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Renovatio Clinical

Recruiting

Houston, Texas, United States, 77030

Texas Oncology - Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

US Oncology Research Investigational Products Center

Recruiting

Tyler, Texas, United States, 75702

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22903

Virginia Cancer Specialists PC

Recruiting

Leesburg, Virginia, United States, 20176

Bon Secours Cancer Institute at Saint Francis

Recruiting

Midlothian, Virginia, United States, 23114

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Centre de Recherche du Centre Hospitalier de l Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Sir Mortimer B Davis - Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

CIUSSS de l Estrie CHUS Hopital Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Amgen

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Prostate Cancer
  • Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
  • Xaluritamig
  • Abiraterone
  • Abiraterone Acetate
  • Docetaxel
  • Cabazitaxel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-27.