NCT07213674招募中3 期
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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 750
- 试验地点
- 177
- 主要终点
- OS
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •Adequate organ function.
排除标准
- •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.
研究组 & 干预措施
Investigator's Choice
Active Comparator
Participants will receive investigator's choice of:
- Abiraterone acetate orally, once daily or
- Docetaxel IV Q3W or
- Cabazitaxel IV Q3W.
干预措施: Abiraterone acetate (Drug)
Investigator's Choice
Active Comparator
Participants will receive investigator's choice of:
- Abiraterone acetate orally, once daily or
- Docetaxel IV Q3W or
- Cabazitaxel IV Q3W.
干预措施: Cabazitaxel (Drug)
Xaluritamig Plus Abiraterone
Experimental
Participants will be randomized to receive xaluritamig in combination with abiraterone acetate.
干预措施: Abiraterone acetate (Drug)
Investigator's Choice
Active Comparator
Participants will receive investigator's choice of:
- Abiraterone acetate orally, once daily or
- Docetaxel IV Q3W or
- Cabazitaxel IV Q3W.
干预措施: Docetaxel (Drug)
Xaluritamig Plus Abiraterone
Experimental
Participants will be randomized to receive xaluritamig in combination with abiraterone acetate.
干预措施: Xaluritamig (Drug)
结局指标
主要结局
OS
时间窗: Up to approximately 51 months
次要结局
- 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 51 months)
- Objective Response per Modified RECIST 1.1, Per Investigator Assessment(Up to approximately 51 months)
- Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment(Up to approximately 51 months)
- Disease Control Per Modified RECIST 1.1, Per Investigator Assessment(Up to approximately 51 months)
- Progression-free Survival (PFS) 2, Per Investigator Assessment(Up to approximately 51 months)
- Time to Response (TTR), Per Modified RECIST 1.1, Per Investigator Assessment(Up to approximately 51 months)
- Time to First Subsequent Therapy(Up to approximately 51 months)
- Time to Symptomatic Skeletal Events (SSE)(Up to approximately 51 months)
- Number of Participants With Treatment-emergent Adverse events, Treatment-emergent Serious Adverse Events, and Fatal Adverse Events(Up to approximately 51 months)
- Change From Baseline Over Time at Each Assessment in Brief Pain Inventory - Short Form (BPI-SF) Pain Intensity Scale(Up to approximately 51 months)
- Change From Baseline Over Time at Each Assessment in BPI-SF Worst Pain Score(Up to approximately 51 months)
- Change From Baseline Over Time at Each Assessment in BPI-SF Pain Interference Scale(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(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(Up to approximately 51 months)
- Change From Baseline Over Time at Each Assessment in the EQ-5D-5L Visual Analogue Scale (VAS)(Up to approximately 51 months)
- Time to Worsening as Measured by BPI-SF Worst Pain Score(Up to approximately 51 months)
- Time to Worsening as Measured by BPI-SF Pain Intensity Scale(Up to approximately 51 months)
- Time to Worsening as Measured by BPI-SF Pain Interference Scale(Up to approximately 51 months)
- Time to Worsening as Measured by FACT-P Total Score(Up to approximately 51 months)
- Time to Improvement as Measured by BPI-SF Worst Pain Score in Participants with Moderate/Severe Pain at Baseline(Up to approximately 51 months)
- Time to Improvement After Worsening as Measured by BPI-SF Pain Intensity Scale Score(Up to approximately 51 months)
- Time to Improvement After Worsening as Measured by BPI-SF Pain Interference Scale Score(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(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(Up to approximately 51 months)
- Prostate-specific Antigen (PSA) 50 and PSA 90 Responses(Up to approximately 51 months)
- Time to PSA 50 and PSA 90 Response(Up to approximately 51 months)
- Duration of PSA 50 and PSA 90 Response(Up to approximately 51 months)
- Time to PSA Progression(Up to approximately 51 months)
- Maximum Serum Concentration (Cmax) of Xaluritamig(Up to approximately 51 months)
- Time to Maximum Concentration (Tmax) of Xaluritamig(Up to approximately 51 months)
- Minimum Serum Concentration (Cmin) of Xaluritamig(Up to approximately 51 months)
- Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig(Up to approximately 51 months)
- Accumulation Ratio of the AUC Over the Dosing Interval for Xaluritamig(Up to approximately 51 months)
- Half-life (t1/2) of Xaluritamig(Up to approximately 51 months)
- Abiraterone Serum Concentrations(Up to approximately 51 months)
- Number of Participants with Formation of Anti-xaluritamig Antibodies(Up to approximately 51 months)
研究者
研究点 (177)
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