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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorAmgen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.

Prior disease progression on or intolerance to abiraterone.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Xaluritamig

    Drug

    Xaluritamig will be administered IV.

  • Abiraterone acetate

    Drug

    Abiraterone acetate will be administered orally.

  • Docetaxel

    Drug

    Docetaxel will be administered IV.

  • Cabazitaxel

    Drug

    Cabazitaxel will be administered IV.

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Xaluritamig Plus AbirateroneExperimental treatment 2 interventions
Group B: Investigator's ChoiceActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

OS

Time frame
Up to approximately 51 months

Secondary outcomes

1

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
2

Objective Response per Modified RECIST 1.1, Per Investigator Assessment

Time frame
Up to approximately 51 months
3

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

Time frame
Up to approximately 51 months
4

Disease Control Per Modified RECIST 1.1, Per Investigator Assessment

Time frame
Up to approximately 51 months

Other outcomes

Sponsors and contacts

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