Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts 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, 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 first dose of study treatment. Participants who received < 2 cycles of PSMA RLT within 6 weeks of first dose of study treatment are also excluded. - 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Xaluritamig Plus Abiraterone
Participants will be randomized to receive xaluritamig in combination with abiraterone acetate.
  • Drug: Xaluritamig
    Xaluritamig will be administered IV.
    Other names:
    • AMG 509
  • Drug: Abiraterone acetate
    Abiraterone acetate will be administered orally.
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.
  • Drug: Abiraterone acetate
    Abiraterone acetate will be administered orally.
  • Drug: Docetaxel
    Docetaxel will be administered IV.
  • Drug: Cabazitaxel
    Cabazitaxel will be administered IV.

Recruiting Locations

City of Hope National Medical Center
Duarte 5344147, California 5332921 91010

City of Hope Orange County Lennar Foundation Cancer Center
Duarte 5344147, California 5332921 91010

University of Illinois Chicago
Chicago 4887398, Illinois 4896861 60612

Norton Cancer Institute
Louisville 4299276, Kentucky 6254925 40207

Hightower Clinical
Oklahoma City 4544349, Oklahoma 4544379 73102

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.