A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

Amgen261 个研究点分布在 8 个国家目标入组 675 人2024年12月9日

适应症Metastatic Castration-resistant Prostate Cancer

干预措施Xaluritamig Abiraterone Enzalutamide Cabazitaxel

概览

阶段: 3 期
干预措施: Xaluritamig
疾病 / 适应症: Metastatic Castration-resistant Prostate Cancer
发起方: Amgen
入组人数: 675
试验地点: 261
主要终点: Overall Survival (OS)
状态: 招募中
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

概览

简要总结

The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy [ARDT]).

注册库

clinicaltrials.gov

开始日期

2024年12月9日

结束日期

2029年7月30日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

Male

研究者

发起方

Amgen

责任方

Sponsor

入排标准

入选标准

•Participant has provided informed consent prior to 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.
•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 prior to enrollment.
•Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
•Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal 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 one 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 lesion(s) by bone scan (as per the 2+2 PCWG3 criteria).
•Participants must have had a prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
•Prior progression on at least one ARDT (enzalutamide, abiraterone, apalutamide, darolutamide).

排除标准

•Prior \& Concomitant Therapy:
•Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
•Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to the first dose of study treatment, not including androgen receptor pathway inhibitors (ARPIs) (abiraterone, enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment and 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 the first dose of study treatment unless participants received \< 2 cycles of therapy.
•Prior palliative radiotherapy within 2 weeks of first dose of study treatment. Participants must have recovered from all radiation-related toxicities.
•Concurrent cytotoxic chemotherapy, ARDT, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, investigational therapy. Note: Prior treatment with a PARP inhibitor is permitted as long as not within 4 weeks before first dose of study treatment.
•Prior radionuclide therapy (Radium-223) within 2 months of first dose of study treatment.
•Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.
•Disease Related:
•Participants with a history of central nervous system (CNS) metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.

研究组 & 干预措施

Xaluritamig

Participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion.

干预措施: Xaluritamig

Cabazitaxel/Abiraterone/Enzalutamide

Participants with mCRPC will be randomized to receive cabazitaxel as an IV infusion, or a second androgen receptor-directed therapy of either abiraterone as oral tablets, or enzalutamide as oral tablets at the investigator's discretion.

干预措施: Abiraterone

Cabazitaxel/Abiraterone/Enzalutamide

干预措施: Enzalutamide

Cabazitaxel/Abiraterone/Enzalutamide

干预措施: Cabazitaxel

结局指标

主要结局

Overall Survival (OS)

时间窗: Up to approximately 53 months

次要结局

Time to First Symptomatic Skeletal Events (SSE)(Up to approximately 53 months)
Change from Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Score(Baseline and approximately 53 months)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(Up to approximately 53 months)
Change from Baseline in BPI-SF Pain Intensity Scale Score(Baseline and approximately 53 months)
Change from Baseline in BPI-SF Pain Interference Scale Score(Baseline and approximately 53 months)
Change from baseline in the EQ-5D-5L Visual Analogue Scale (VAS)(Baseline and approximately 53 months)
Change from baseline in the European Quality of Life 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score(Baseline and approximately 53 months)
Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)(Up to approximately 53 months)
Objective Response Rate per Modified RECIST v1.1 as Assessed by BICR(Up to approximately 53 months)
Duration of Response (DOR) per Modified RECIST v1.1 as Assessed by BICR(Up to approximately 53 months)
Disease Control Rate per Modified RECIST v1.1 as Assessed by BICR(Up to approximately 53 months)
Time to Response (TTR) per Modified RECIST v1.1 as Assessed by BICR(Up to approximately 53 months)
Change from Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score and Subscale Score(Baseline and approximately 53 months)
Time to Worsening in BPI-SF Worst Pain Score(Up to approximately 53 months)
Time to Worsening in BPI-SF Pain Intensity Scale Score(Up to approximately 53 months)
Time to Worsening in BPI-SF Pain Interference Scale Score(Up to approximately 53 months)
Time to Worsening in FACT-P Total Score(Up to approximately 53 months)
Time to Pain Improvement in Participants with Moderate/Severe Pain at Baseline(Up to approximately 53 months)
Time to Pain Improvement after Worsening in BPI-SF Pain Intensity Scale Score(Up to approximately 53 months)
Time to Pain Improvement after Worsening in BPI-SF Pain Interference Scale(Up to approximately 53 months)
Number of Patient-Reported Symptomatic AEs per Patient-reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library(Up to approximately 53 months)
Patient-Reported Summary Scores for Overall Bother of Side Effects per FACT-P(Up to approximately 53 months)
Percentage of Participants Achieving a ≥50% Reduction in Prostate-specific Antigen (PSA) (PSA50)(Up to approximately 53 months)
Percentage of Participants Achieving a ≥90% Reduction in PSA (PSA90)(Up to approximately 53 months)
Maximum Serum Concentration (Cmax) of Xaluritamig(Up to approximately 53 months)
Time to Cmax (Tmax) of Xaluritamig(Up to approximately 53 months)
Minimum Serum Concentration (Cmin) of Xaluritamig(Up to approximately 53 months)
Area Under the Concentration-time Curve (AUC) of Xaluritamig(Up to approximately 53 months)
Accumulation Following Multiple Dosing of Xaluritamig(Up to approximately 53 months)
Half-life (t1/2) of Xaluritamig(Up to approximately 53 months)
Number of Participants with Anti-xaluritamig Antibody(Up to approximately 53 months)