转移性去势抵抗性前列腺癌 (mCRPC) 疗法的安全性和有效性
2026年8月4日 更新者：Amgen
评估转移性去势抵抗性前列腺癌 (mCRPC) 治疗的安全性和有效性的主要方案
这是一项旨在评估研究性疗法在转移性去势抵抗性前列腺癌 (mCRPC) 参与者中的安全性和有效性的主要方案。
研究概览
详细说明
这是一项旨在评估阿卡帕单抗联合恩杂鲁胺、阿比特龙或 PD1 抑制剂 AMG 404、AMG 404 单一疗法的安全性、耐受性和最大耐受剂量 (MTD) 或推荐的 2 期剂量 (RP2D) 和疗效的主要方案，以及 Acapatamab 单一疗法，用于转移性去势抵抗性前列腺癌 (mCRPC) 的参与者。
研究类型
介入性
注册 (实际的)
55
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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København Ø、丹麦、2100
- Rigshospitalet
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New South Wales
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Darlinghurst、New South Wales、澳大利亚、2010
- St Vincents Hospital Sydney
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Lund、瑞典、221 85
- Skånes universitetssjukhus
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Stockholm、瑞典、171 76
- Karolinska Universitetssjukhuset Solna
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Uppsala、瑞典、75185
- Akademiska Sjukhuset
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
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California
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Orange、California、美国、92868
- University of California at Irvine Medical Center
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San Francisco、California、美国、94158
- University of California San Francisco Mission Bay Campus
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Illinois
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Chicago、Illinois、美国、60637
- University of Chicago
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Kentucky
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Louisville、Kentucky、美国、40207
- Norton Cancer Institute
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Texas
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Dallas、Texas、美国、75390
- University of Texas Southwestern Medical Center
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Houston、Texas、美国、77030
- University of Texas MD Anderson Cancer Center
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Sutton、英国、SM2 5PT
- Royal Marsden Hospital
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Navarre
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Pamplona、Navarre、西班牙、31008
- Clinica Universidad de Navarra
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 99年 (成人、年长者)
接受健康志愿者
不
描述
所有部分
纳入标准：
- ≥ 18 岁（或国内法定成年年龄）
- 在开始任何特定于研究的活动/程序之前，受试者已提供知情同意书
- 经组织学或细胞学证实为前列腺腺癌的 mCRPC 受试者
- 受试者应接受双侧睾丸切除术或应使用促性腺激素释放激素激动剂或拮抗剂（睾酮≤ 50 ng/dL（或 1.7 nmol/L））进行连续雄激素剥夺治疗
排除标准：
- 中枢神经系统 (CNS) 转移或软脑膜疾病
- 临床相关 CNS 病理的病史或存在
- 确诊病史或当前自身免疫性疾病或其他需要永久性免疫抑制治疗的疾病
- 12 个月内发生心肌梗塞、未控制的高血压、不稳定型心绞痛、需要药物治疗的心律失常和/或有症状的充血性心力衰竭（纽约心脏协会 > II 级）
- 先前使用紫杉烷治疗 mCRPC
- 4 周内进行大手术和/或放疗
严重急性呼吸系统综合症冠状病毒 2 (SARS-CoV-2) 感染史或证据，除非与医学监测员达成一致并满足以下标准：
- 在首次服用 Acapatamab（或第 3 部分中的 AMG 404）后 72 小时内通过实时聚合酶链反应 (RT-PCR) 对 SARS-CoV-2 RNA 进行阴性检测
- 在第一次服用 Acapatamab（或第 3 部分中的 AMG 404）之前 10 天内没有出现 COVID-19 疾病的急性症状（从无症状受试者的阳性测试日开始计算）
先前/同时进行的临床研究经验
- 目前正在接受另一项研究设备或药物研究的治疗，或在另一项研究设备或药物研究结束治疗后不到 4 周。 参与本研究的其他调查程序被排除在外，调查扫描除外。
仅限子协议 A：
纳入标准
• 计划首次接受恩杂鲁胺治疗 mCRPC 的受试者
排除标准
- 使用强 CYP2C8 抑制剂或强 CYP3A4 诱导剂
- 使用作为 CYP3A4、CYP2C9 或 CYP2C19 底物的窄治疗指数药物
仅子协议 B：
纳入标准
- 计划首次接受阿比特龙用于 mCRPC 排除标准的受试者
- 基线中度和重度肝功能损害（Child-Pugh B 级和 C 级）
- 存在不受控制的高血压、低钾血症或体液潴留
- 肾上腺皮质功能不全的病史或存在
- 使用作为 CYP2D6 敏感底物且治疗指数窄的伴随药物
- 使用强 CYP3A4 诱导剂
仅子协议 C：
纳入标准
- 对新型抗雄激素疗法难以治疗的受试者。 受试者必须不符合或拒绝紫杉烷治疗。
- 进展性疾病的证据，定义为 1 项或多项 PCWG3 标准：PSA 水平 >/=1 ng/mL，至少连续 2 次增加，间隔至少 1 周，淋巴结或内脏进展，如 RECIST 1.1 定义，PCGW3 修改，和/或在骨扫描中出现 2 个或更多新病灶 排除标准
- 间质性肺病或活动性非感染性肺炎的病史或证据
- 在给药第一天之前经历过 3 级或更高级别免疫相关不良事件的先前 PD-1 或 PD-L1 抑制剂的受试者
仅子协议 D：
纳入标准
- 受试者可能接受过针对前列腺癌的新型激素疗法（NHT；例如，阿比特龙、恩杂鲁胺、阿帕鲁胺或达洛鲁胺），但对于转移性前列腺癌，接受过的 NHT 不超过 1 次
- 不符合或拒绝紫杉烷治疗
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：阿卡帕他单抗和恩杂鲁胺：剂量探索
该研究的剂量探索部分将估计 Acapatamab 与恩杂鲁胺联合使用的 MTD/推荐 2 期剂量 (RP2D)。
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Acapatamab 将作为静脉内 (IV) 输液给药。
其他名称：
恩杂鲁胺将口服给药。
其他名称：
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实验性的：阿卡帕他单抗和恩杂鲁胺：剂量扩展
在剂量探索之后，将进行剂量扩展以确认所选剂量的安全性和耐受性，并进一步评估 Acapatamab 与恩杂鲁胺联合使用的疗效。
|
Acapatamab 将作为静脉内 (IV) 输液给药。
其他名称：
恩杂鲁胺将口服给药。
其他名称：
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实验性的：阿卡帕单抗和阿比特龙：剂量探索
该研究的剂量探索部分将估计 Acapatamab 与阿比特龙联合使用的 MTD/推荐 2 期剂量 (RP2D)。
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Acapatamab 将作为静脉内 (IV) 输液给药。
其他名称：
阿比特龙将口服给药。
其他名称：
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实验性的：阿卡帕单抗和阿比特龙：剂量扩展
在剂量探索之后，将进行剂量扩展以确认所选剂量的安全性和耐受性，并进一步评估 Acapatamab 联合阿比特龙的疗效。
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Acapatamab 将作为静脉内 (IV) 输液给药。
其他名称：
阿比特龙将口服给药。
其他名称：
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实验性的：Acapatamab 和 AMG 404：剂量探索
该研究的剂量探索部分将估计 Acapatamab 与 AMG 404 联合使用的 MTD/RP2D。
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Acapatamab 将作为静脉内 (IV) 输液给药。
其他名称：
AMG 404 将作为静脉内 (IV) 输注给药。
其他名称：
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实验性的：Acapatamab 和 AMG 404：剂量扩展
在剂量探索之后，将进行剂量扩展以确认所选剂量的安全性和耐受性，并进一步评估 Acapatamab 与 AMG 404 联合使用的疗效。
|
Acapatamab 将作为静脉内 (IV) 输液给药。
其他名称：
AMG 404 将作为静脉内 (IV) 输注给药。
其他名称：
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有源比较器：AMG 404 单一疗法
正在进行 AMG 404 单一疗法，以评估 PD-1 抑制在 mCRPC 人群中的初步抗肿瘤活性。
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AMG 404 将作为静脉内 (IV) 输注给药。
其他名称：
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实验性的：阿卡帕他单抗和恩杂鲁胺：剂量扩展亚洲队列
在剂量探索之后，将在亚洲队列中以剂量探索中确定的 MTD/RP2D 组合进行剂量扩展，以确认 Acapatamab 与恩杂鲁胺联合用于亚洲受试者的安全性、耐受性和 PK。
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Acapatamab 将作为静脉内 (IV) 输液给药。
其他名称：
恩杂鲁胺将口服给药。
其他名称：
|
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实验性的：阿卡帕单抗和阿比特龙：剂量扩展亚洲队列
在剂量探索之后，将在亚洲队列中以剂量探索中确定的 MTD/RP2D 组合进行剂量扩展，以确认 Acapatamab 与阿比特龙联合用于亚洲受试者的安全性、耐受性和 PK。
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Acapatamab 将作为静脉内 (IV) 输液给药。
其他名称：
阿比特龙将口服给药。
其他名称：
|
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实验性的：Acapatamab 和 AMG 404：剂量扩展亚洲队列
在剂量探索之后，将在亚洲队列中以剂量探索中确定的 MTD/RP2D 组合进行剂量扩展，以确认 Acapatamab 与 AMG 404 联合用于亚洲受试者的安全性、耐受性和 PK。
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Acapatamab 将作为静脉内 (IV) 输液给药。
其他名称：
AMG 404 将作为静脉内 (IV) 输注给药。
其他名称：
|
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实验性的：阿卡帕单抗单药治疗
正在进行 Acapatamab 单药治疗以评估 Acapatamab 在 mCRPC 受试者中的安全性、耐受性、药代动力学（PK）、药效学和疗效。
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Acapatamab 将作为静脉内 (IV) 输液给药。
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
大体时间：Cycle 1: Day 1 to Day 28 (28-day cycle)
|
DLTs were defined as any adverse event (AE) (per Common Terminology Criteria for Adverse Events (CTCAE) v5: Grade 5=Death, Grade 4=Life-threatening, Grade 3=Moderate) occurring within 28 days of the first AMG 160 dose, possibly related to the treatment, including:
The complete list of DLTs are described in the protocol |
Cycle 1: Day 1 to Day 28 (28-day cycle)
|
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Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs
大体时间：From first dose of acapatamab/AMG 404 to the first of 30 days after last dose of acapatamab/AMG404, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 4.665 (0.33, 25.17) months
|
A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started on or after first dose of investigational product (AMG 160 or AMG 404 for Part 1 and 2; AMG 404 for Part 3). A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab, or AMG 404 (subprotocol C, parts 1 and 2 only). Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs. |
From first dose of acapatamab/AMG 404 to the first of 30 days after last dose of acapatamab/AMG404, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 4.665 (0.33, 25.17) months
|
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Subprotocol D: Number of Participants Who Experienced TEAEs and Treatment-related AEs
大体时间：From first dose of acapatamab to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy, whichever is earlier; median (min, max) duration was 4.665 (0.33, 25.17) months
|
A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started after the first dose of acapatamab. A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab. Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs. |
From first dose of acapatamab to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy, whichever is earlier; median (min, max) duration was 4.665 (0.33, 25.17) months
|
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Subprotocol C, Part 3: Objective Response Rate (ORR)
大体时间：From Cycle 1 Day 1 until progression, start of new anticancer therapy, or end of trial median (min, max) duration was 6.14 (0.14, 105.14) weeks
|
Objective Response is defined as a complete response (CR) or partial response (PR) per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later.
Participants who did not experience a confirmed CR or PR, or did not have any follow-up tumor assessments were regarded as non-responders.
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From Cycle 1 Day 1 until progression, start of new anticancer therapy, or end of trial median (min, max) duration was 6.14 (0.14, 105.14) weeks
|
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Subprotocol C, Part 3: Percentage of Participants Who Experienced a Circulating Tumor Cell 0 (CTC0) Response
大体时间：Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
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CTC0 response was defined as CTC0 (reduction of CTCs > 0 to 0 at any post-baseline measurement).
The baseline was defined as the last non-missing value on or prior to the pre-dose of AMG 404 assessments on Cycle 1 Day 1.
|
Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
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Subprotocol C, Part 3: Percentage of Participants Who Experienced a CTC Conversion Response
大体时间：Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
CTC conversion response was defined as ≥ 5 CTCs/7.5 mL blood at baseline that converted to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement.
The baseline was defined as the last non-missing value on or prior to the pre-dose assessments of AMG 404 on Cycle 1 Day 1.
|
Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
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Subprotocol C, Part 3: Percentage of Participants Who Experienced a Prostate Specific Antigen (PSA) Response
大体时间：Cycle 1 Day 1 to 5 months post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:
The baseline was defined as the last non-missing value on or prior to the pre-dose of AMG 404 assessments on Cycle 1 Day 1. |
Cycle 1 Day 1 to 5 months post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subprotocols A. B, C (Parts 1 and 2) and D: ORR
大体时间：From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Objective Response is defined as a CR or PR per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later.
Participants who did not experience a confirmed CR or PR, or did not have any follow-up tumor assessments were regarded as non-responders.
|
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC0 Response
大体时间：From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
CTC0 response was defined as CTC0 (reduction of CTCs > 0 to 0 at any post-baseline measurement).
The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1 > 0.
|
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC Conversion Response
大体时间：From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
CTC conversion response was defined as ≥ 5 CTCs/7.5 mL blood at baseline that converted to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement.
The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1.
|
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a PSA Response
大体时间：Cycle 1 Day 1 to 5 months post-last dose of acapatamab/AMG 404 (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:
The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1. |
Cycle 1 Day 1 to 5 months post-last dose of acapatamab/AMG 404 (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC0 Response
大体时间：From date of initial CTC0 response to the earlier of CTC0 progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Duration of CTC0 response was defined as the time from the date of initial CTC0 response to the earlier of CTC0 progression or death.
Participants who had not ended their response at the time of analysis had duration of CTC0 response censored on the date of their last CTC0 or CTC conversion assessment.
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From date of initial CTC0 response to the earlier of CTC0 progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC Conversion Response
大体时间：From the date of an initial CTC conversion response to the earlier of CTC conversion progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Duration of CTC conversion response was defined as the time from the date of an initial CTC conversion response to the earlier of CTC conversion progression or death.
Participants who had not ended their response at the time of analysis had duration of CTC response censored on the date of their last CTC0 or CTC conversion assessment.
|
From the date of an initial CTC conversion response to the earlier of CTC conversion progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of PSA Response
大体时间：From date of an initial PSA response (PSA 50) to the earlier of PSA progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Duration of PSA response was defined as the time of an initial PSA response (PSA 50) to the earlier of PSA progression or death.
Participants who had not ended their response at the time of analysis had duration of PSA response censored on the date of their last PSA measurement.
|
From date of an initial PSA response (PSA 50) to the earlier of PSA progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of Response Per RECIST 1.1
大体时间：From date of an initial objective response per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Duration of response per RECIST 1.1 was defined as the time from the date of an initial objective response (CR/PR) per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death.
CR/PR must have been confirmed at least 4 weeks later.
Participants who had not ended their response at the time of analysis had duration of response censored at their last evaluable tumor assessment by computed tomography (CT)/magnetic resonance imaging (MRI) scan.
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From date of an initial objective response per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Overall Survival (OS)
大体时间：From the date of study Day 1 until death due to any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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OS was defined as the time from the date of trial Day 1 until death due to any cause.
OS time (months) = (date of death - trial Day 1 + 1) x 12/365.25.
Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was alive.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Kalbfleisch and Prentice.
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From the date of study Day 1 until death due to any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Radiographic Progression Free Survival (rPFS)
大体时间：From trial Day 1 to the earlier of a radiographic progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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rPFS was defined as the time from trial Day 1 to radiographic progression.
If a participant had no evaluable post-baseline and on-trial disease assessment and was on trial without disease progression (PD) or death recorded, rPFS was censored on the date of the first dose of the investigational product (IP).
rPFS was censored at the last evaluable radiographic tumor assessment date for participants who had no PD, death or new anti-cancer therapy reported, started a new anti-cancer therapy prior to PD or death, if death recorded without new anti-cancer therapy and without PD, if death or PD immediately after more than one consecutively missed tumor assessment occurred.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
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From trial Day 1 to the earlier of a radiographic progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: PSA PFS
大体时间：From trial Day 1 to the earlier of a PSA progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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PSA PFS was defined as the interval from trial Day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS was censored on the date of the last PSA measurement.
If a participant had no baseline or post-baseline PSA measurement and a vital status of alive or known, PSA PFS was censored at trial Day 1.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to the earlier of a PSA progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Clinical PFS
大体时间：From first dose of acapatamab or AMG 404 (subprotocol C only) to clinical disease progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Clinical PFS was defined as the time from the first dose to clinical disease progression or death from any cause.
If a participant had no evaluable post-baseline or on-trial disease assessment or was on trial without PD or death recorded, clinical PFS was censored on the date of the first dose of the IP.
Otherwise, clinical PFS was censored on the date of last assessment.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
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From first dose of acapatamab or AMG 404 (subprotocol C only) to clinical disease progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Radiographic Progression
大体时间：From trial Day 1 to radiographic progression in the absence of subsequent anticancer therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Time to radiographic progression was defined as the interval from Day 1 to radiographic progression in the absence of subsequent anticancer therapy. If a participant had no evaluable post-baseline and on-trial disease assessment and was on trial without PD or death recorded, time to radiographic progression was censored on the date of the first dose of the IP. Time to radiographic progression was censored on the date of last evaluable radiographic tumor assessment for participants who:
The median was estimated using the Kaplan-Meier method and the 95% CI was estimated using the method by Brookmeyer and Crowley. |
From trial Day 1 to radiographic progression in the absence of subsequent anticancer therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to PSA Progression
大体时间：From trial Day 1 to PSA progression (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Time to PSA progression was defined as the interval from trial Day 1 to PSA progression.
If a participant had no evaluable post-baseline or on-trial PSA assessment, time to PSA progression was censored on the date of the first dose of the IP.
Otherwise, time to PSA progression was censored on the date of the last PSA assessment.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to PSA progression (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Subsequent Therapy
大体时间：From trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Time to subsequent therapy was defined as the interval from trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy; otherwise, time to subsequent therapy was censored at the last known date of any of the trial assessments prior to initiating the subsequent cancer therapy/subsequent therapy.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Percentage of Participants Who Experienced a Gallium Prostate-specific Membrane Antigen-11 (PSMA-11) Response
大体时间：Cycle 1 Day 1 to 14 days post-last dose of acapatamab or AMG 404 (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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A Gallium PSMA-11 response was defined as a ≥ 50% reduction from baseline in the maximum standardized update value (SUV) using 68Gallium (68Ga)-PSMA-11 positron emission tomography (PET)/CT.
PSMA-11 response percentages were based on the number of participants with a baseline PSMA assessment (defined as the last non-missing value on or prior to the pre-dose of acapatamab/AMG 404 assessments) on Cycle 1 Day 1.
The 95% confidence interval was calculated based on the Clopper-Pearson method.
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Cycle 1 Day 1 to 14 days post-last dose of acapatamab or AMG 404 (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Symptomatic Skeletal Events
大体时间：From trial Day 1 to the first symptomatic skeletal event (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Time to symptomatic skeletal events was defined as time from trial Day 1 to the first symptomatic skeletal event, otherwise time to symptomatic skeletal event was censored at the last dose of acapatamab/AMG 404 or end of safety follow-up date, whichever was later.
Symptomatic skeletal events included fracture, spinal cord compression and radiation or surgery to bone.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to the first symptomatic skeletal event (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Total Alkaline Phosphatase Levels
大体时间：Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Alkaline phosphatase levels were collected locally and centrally.
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Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Bone Specific Alkaline Phosphatase Levels
大体时间：Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
Bone specific alkaline phosphatase levels were collected locally and centrally.
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Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Lactate Dehydrogenase Levels
大体时间：Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
Lactate dehydrogenase levels were collected locally and centrally.
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Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Hemoglobin Levels
大体时间：Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
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Hemoglobin levels were collected locally.
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Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Neutrophil-to-lymphocyte Ratio
大体时间：Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
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Data for the neutrophil-to-lymphocyte ratio were collected locally.
Neutrophil-to-lymphocyte ratio was calculated by dividing the number of absolute neutrophils by the number of lymphocytes.
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Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Urine N-telopeptide Levels
大体时间：Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Urine N-telopeptide levels were collected centrally.
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Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Subprotocol A, B and C (Parts 1 and 2) and D: Maximum Serum Concentration (Cmax) of Acapatamab
大体时间：Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Serum concentrations of acapatamab were determined using a validated assay.
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Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Subprotocol A, B and C (Parts 1 and 2) and D: Area Under the Curve Over the Dosing Interval (AUCtau)
大体时间：Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Serum concentrations of acapatamab were determined using a validated assay.
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Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Subprotocol A, B and C (Parts 1 and 2) and D: Time to Reach Cmax (Tmax) of Acapatamab
大体时间：Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Serum concentrations of acapatamab were determined using a validated assay.
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Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Subprotocol A, B and C (Parts 1 and 2) and D: Terminal Half-life (t1/2z) of Acapatamab
大体时间：Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Serum concentrations of acapatamab were determined using a validated assay.
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Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Subprotocol C, Part 3: Number of Participants Who Experienced TEAEs and Treatment-related AEs
大体时间：From first dose of AMG 404 to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 6.14 (0.14, 105.14) weeks
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A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started after the first dose of acapatamab. A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab. Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs. |
From first dose of AMG 404 to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 6.14 (0.14, 105.14) weeks
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合作者和调查者
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出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月15日
初级完成 (实际的)
2023年10月23日
研究完成 (实际的)
2023年10月23日
研究注册日期
首次提交
2020年11月13日
首先提交符合 QC 标准的
2020年11月13日
首次发布 (实际的)
2020年11月17日
研究记录更新
最后更新发布 (实际的)
2026年8月26日
上次提交的符合 QC 标准的更新
2026年8月4日
最后验证
2026年7月1日
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与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 20190505
- 2020-001305-23 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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IPD 计划说明
在已批准的数据共享请求中，为解决特定研究问题所需的变量取消识别个体患者数据。
IPD 共享时间框架
与本研究相关的数据共享请求将在研究结束后 18 个月开始考虑，并且 1) 产品和适应症已在美国和欧洲获得上市许可，或 2) 产品和/或适应症的临床开发停止并且数据不会提交给监管机构。
没有资格为本研究提交数据共享请求的截止日期。
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经批准后，将根据数据共享协议的条款提供解决研究问题所需的信息。
这可能包括匿名的个体患者数据和/或可用的支持文件，其中包含分析规范中提供的分析代码片段。
更多详细信息，请访问以下 URL。
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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药物和器械信息、研究文件
研究美国 FDA 监管的药品
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研究美国 FDA 监管的设备产品
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