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RecruitingInterventionalPhase 3

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

NCT ID: NCT07213674Sponsor: AmgenLast updated: 2026-06-18

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).

Arms & interventions

  • DrugXaluritamig

    Xaluritamig will be administered IV.

  • DrugAbiraterone acetate

    Abiraterone acetate will be administered orally.

  • DrugDocetaxel

    Docetaxel will be administered IV.

  • DrugCabazitaxel

    Cabazitaxel will be administered IV.

Outcome measures

Primary

  • OS

    Time frame: Up to approximately 51 months

Secondary

  • Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Per Investigator Assessment

    Time frame: Up to approximately 51 months

  • Objective Response per Modified RECIST 1.1, Per Investigator Assessment

    Time frame: Up to approximately 51 months

  • Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment

    Time frame: Up to approximately 51 months

  • Disease Control Per Modified RECIST 1.1, Per Investigator Assessment

    Time frame: Up to approximately 51 months

  • Progression-free Survival (PFS) 2, Per Investigator Assessment

    Time frame: Up to approximately 51 months

  • Time to Response (TTR), Per Modified RECIST 1.1, Per Investigator Assessment

    Time frame: Up to approximately 51 months

  • Time to First Subsequent Therapy

    Time frame: Up to approximately 51 months

  • Time to Symptomatic Skeletal Events (SSE)

    Time frame: Up to approximately 51 months

  • Number of Participants With Treatment-emergent Adverse events, Treatment-emergent Serious Adverse Events, and Fatal Adverse Events

    Time frame: Up to approximately 51 months

  • Change From Baseline Over Time at Each Assessment in Brief Pain Inventory - Short Form (BPI-SF) Pain Intensity Scale

    Time frame: Up to approximately 51 months

  • Change From Baseline Over Time at Each Assessment in BPI-SF Worst Pain Score

    Time frame: Up to approximately 51 months

  • Change From Baseline Over Time at Each Assessment in BPI-SF Pain Interference Scale

    Time frame: Up to approximately 51 months

  • Change From Baseline Over Time at Each Assessment in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score and Subscale Scores

    Time frame: Up to approximately 51 months

  • Change From Baseline Over Time at Each Assessment in European Quality of Life (EuroQol) 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score

    Time frame: Up to approximately 51 months

  • Change From Baseline Over Time at Each Assessment in the EQ-5D-5L Visual Analogue Scale (VAS)

    Time frame: Up to approximately 51 months

  • Time to Worsening as Measured by BPI-SF Worst Pain Score

    Time frame: Up to approximately 51 months

  • Time to Worsening as Measured by BPI-SF Pain Intensity Scale

    Time frame: Up to approximately 51 months

  • Time to Worsening as Measured by BPI-SF Pain Interference Scale

    Time frame: Up to approximately 51 months

  • Time to Worsening as Measured by FACT-P Total Score

    Time frame: Up to approximately 51 months

  • Time to Improvement as Measured by BPI-SF Worst Pain Score in Participants with Moderate/Severe Pain at Baseline

    Time frame: Up to approximately 51 months

  • Time to Improvement After Worsening as Measured by BPI-SF Pain Intensity Scale Score

    Time frame: Up to approximately 51 months

  • Time to Improvement After Worsening as Measured by BPI-SF Pain Interference Scale Score

    Time frame: Up to approximately 51 months

  • Summary Scores Over Time at Each Assessment as Measured by Selected Questions on Symptomatic Adverse Events from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library

    Time frame: Up to approximately 51 months

  • Summary Scores Over Time at Each Assessment as Measured by the GP5 Question on Overall Bother of Side Effects from the FACT-P Questionnaire

    Time frame: Up to approximately 51 months

  • Prostate-specific Antigen (PSA) 50 and PSA 90 Responses

    Time frame: Up to approximately 51 months

  • Time to PSA 50 and PSA 90 Response

    Time frame: Up to approximately 51 months

  • Duration of PSA 50 and PSA 90 Response

    Time frame: Up to approximately 51 months

  • Time to PSA Progression

    Time frame: Up to approximately 51 months

  • Maximum Serum Concentration (Cmax) of Xaluritamig

    Time frame: Up to approximately 51 months

  • Time to Maximum Concentration (Tmax) of Xaluritamig

    Time frame: Up to approximately 51 months

  • Minimum Serum Concentration (Cmin) of Xaluritamig

    Time frame: Up to approximately 51 months

  • Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig

    Time frame: Up to approximately 51 months

  • Accumulation Ratio of the AUC Over the Dosing Interval for Xaluritamig

    Time frame: Up to approximately 51 months

  • Half-life (t1/2) of Xaluritamig

    Time frame: Up to approximately 51 months

  • Abiraterone Serum Concentrations

    Time frame: Up to approximately 51 months

  • Number of Participants with Formation of Anti-xaluritamig Antibodies

    Time frame: Up to approximately 51 months

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy 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.

Study locations (30)

City of Hope Cancer Center Phoenix

Goodyear, Arizona, 85338

Recruiting

City of Hope National Medical Center

Duarte, California, 91010

Recruiting

City of Hope Orange County Lennar Foundation Cancer Center

Duarte, California, 91010

Recruiting

Providence Saint Jude Medical Center

Fullerton, California, 92835

Recruiting

Providence Saint Johns Health Center

Santa Monica, California, 90404

Recruiting

Rocky Mountain Cancer Centers

Denver, Colorado, 80218

Recruiting

Medical Oncology Hematology Consultants Helen F Graham Cancer Center

Newark, Delaware, 19713

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

City of Hope Atlanta

Newnan, Georgia, 30265

Recruiting

University of Illinois Chicago

Chicago, Illinois, 60612

Recruiting

Midwestern Regional Medical Center dba City of Hope Chicago

Zion, Illinois, 60099

Recruiting

University of Kansas Medical Center

Westwood, Kansas, 66205

Recruiting

University of Louisville Health - James Graham Brown Cancer Center

Louisville, Kentucky, 40202

Recruiting

Norton Cancer Institute

Louisville, Kentucky, 40207

Recruiting

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201

Recruiting

Johns Hopkins Hospital Sidney Kimmell Comprehensive Cancer Center

Baltimore, Maryland, 21287

Recruiting

Barbara Ann Karmanos Cancer Institute

Lansing, Michigan, 48910

Recruiting

Minnesota Oncology Hematology PA

Minneapolis, Minnesota, 55404

Recruiting

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455

Recruiting

Hematology Oncology Association of Central New York

East Syracuse, New York, 13057

Recruiting

Oncology Hematology Care Incorporated

Cincinnati, Ohio, 45242

Recruiting

Hightower Clinical

Oklahoma City, Oklahoma, 73102

Recruiting

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232

Recruiting

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, 37203

Recruiting

The Center for Cancer and Blood Disorders

Arlington, Texas, 76012

Recruiting

Texas Oncology Northeast Texas

Tyler, Texas, 75702

Recruiting

US Oncology Research Investigational Products Center

Tyler, Texas, 75702

Recruiting

University of Virginia Cancer Center

Charlottesville, Virginia, 22903

Recruiting

Virginia Cancer Specialists PC

Leesburg, Virginia, 20176

Recruiting

Virginia Oncology Associates

Norfolk, Virginia, 23502

Recruiting
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer | Cancerify