A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Not Applicable
Not yet recruiting
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Registration Number
- NCT07213674
- Lead Sponsor
- Amgen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 750
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Xaluritamig Plus Abiraterone Xaluritamig Participants will be randomized to receive xaluritamig in combination with abiraterone acetate. Xaluritamig Plus Abiraterone Abiraterone acetate Participants will be randomized to receive xaluritamig in combination with abiraterone acetate. Investigator's Choice Abiraterone acetate Participants will receive investigator's choice of: * Abiraterone acetate orally, once daily or * Docetaxel IV Q3W or * Cabazitaxel IV Q3W. Investigator's Choice Docetaxel Participants will receive investigator's choice of: * Abiraterone acetate orally, once daily or * Docetaxel IV Q3W or * Cabazitaxel IV Q3W. Investigator's Choice Cabazitaxel Participants will receive investigator's choice of: * Abiraterone acetate orally, once daily or * Docetaxel IV Q3W or * Cabazitaxel IV Q3W.
- Primary Outcome Measures
Name Time Method OS Up to approximately 50 months
- Secondary Outcome Measures
Name Time Method 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 Up to approximately 82 months Objective Response per Modified RECIST 1.1, Per Investigator Assessment Up to approximately 82 months Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment Up to approximately 82 months Disease Control Per Modified RECIST 1.1, Per Investigator Assessment Up to approximately 82 months Progression-free Survival (PFS) 2, Per Investigator Assessment Up to approximately 82 months Time to Response (TTR), Per Modified RECIST 1.1, Per Investigator Assessment Up to approximately 82 months Time to First Subsequent Therapy Up to approximately 82 months Time to Symptomatic Skeletal Events (SSE) Up to approximately 82 months Number of Participants With Treatment-emergent Adverse events, Treatment-emergent Serious Adverse Events, and Fatal Adverse Events Up to approximately 82 months Change From Baseline Over Time at Each Assessment in Brief Pain Inventory - Short Form (BPI-SF) Pain Intensity Scale From baseline up to approximately 22 months Change From Baseline Over Time at Each Assessment in BPI-SF Worst Pain Score From baseline up to approximately 22 months Change From Baseline Over Time at Each Assessment in BPI-SF Pain Interference Scale From baseline up to approximately 22 months Change From Baseline Over Time at Each Assessment in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score and Subscale Scores From baseline up to approximately 22 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 From baseline up to approximately 82 months Change From Baseline Over Time at Each Assessment in the EQ-5D-5L Visual Analogue Scale (VAS) From baseline up to approximately 82 months Time to Worsening as Measured by BPI-SF Worst Pain Score Up to approximately 22 months Time to Worsening as Measured by BPI-SF Pain Intensity Scale Up to approximately 22 months Time to Worsening as Measured by BPI-SF Pain Interference Scale Up to approximately 22 months Time to Worsening as Measured by FACT-P Total Score Up to approximately 22 months Time to Improvement as Measured by BPI-SF Worst Pain Score in Participants with Moderate/Severe Pain at Baseline Up to approximately 22 months Time to Improvement After Worsening as Measured by BPI-SF Pain Intensity Scale Score Up to approximately 22 months Time to Improvement After Worsening as Measured by BPI-SF Pain Interference Scale Score Up to approximately 22 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 Up to approximately 22 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 Up to approximately 22 months Prostate-specific Antigen (PSA) 50 and PSA 90 Responses Up to approximately 82 months Time to PSA 50 and PSA 90 Response Up to approximately 82 months Duration of PSA 50 and PSA 90 Response Up to approximately 82 months Time to PSA Progression Up to approximately 82 months Maximum Serum Concentration (Cmax) of Xaluritamig Up to approximately 22 months Time to Maximum Concentration (Tmax) of Xaluritamig Up to approximately 22 months Minimum Serum Concentration (Cmin) of Xaluritamig Up to approximately 22 months Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig Up to approximately 22 months Accumulation Ratio of the AUC Over the Dosing Interval for Xaluritamig Up to approximately 22 months Half-life (t1/2) of Xaluritamig Up to approximately 22 months Abiraterone Serum Concentrations Up to Day 99 Number of Participants with Formation of Anti-xaluritamig Antibodies Up to approximately 22 months