NCT06691984进行中（未招募）3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 707
- 试验地点
- 262
- 主要终点
- Overall Survival (OS)
研究概览
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]).
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 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).
- •Prior treatment with only one taxane therapy in the mCRPC setting. Note: Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
- •Adequate organ function.
- •Life expectancy of ≥ 12 weeks per the treating physician's assessment.
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.
- •Unresolved toxicities from prior anti-tumor therapy not having resolved to CTCAE version 5.0 events grade above 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.
研究组 & 干预措施
Xaluritamig
Experimental
Participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion.
干预措施: Xaluritamig (Drug)
Cabazitaxel/Abiraterone/Enzalutamide
Active Comparator
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 (Drug)
Cabazitaxel/Abiraterone/Enzalutamide
Active Comparator
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: Enzalutamide (Drug)
Cabazitaxel/Abiraterone/Enzalutamide
Active Comparator
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: Cabazitaxel (Drug)
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)
研究者
研究点 (262)
Loading locations...
相似试验
撤回
3 期
Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric CancerGastric CancerNCT01470742Samsung Medical Center
已完成
3 期
A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT01630733Achieve Life Sciences664
已完成
3 期
A Phase 3 Study of Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)Carcinoma, HepatocellularLiver NeoplasmsNCT00355355Light Sciences Oncology208
已完成
3 期
Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung CancerNon-small Cell Lung CancerNCT03409614Regeneron Pharmaceuticals789
已完成
3 期
Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)Carcinoma，Non-Small-Cell LungLung Carcinomas, Non-Small-CellNon-small-cell Lung CarcinomaNonsmall Cell Lung CancerNCT03088540Regeneron Pharmaceuticals712