ALX148 联合西妥昔单抗和派姆单抗治疗难治性微卫星稳定转移性结直肠癌的研究
2026年8月12日 更新者：University of Colorado, Denver
ALX148 联合西妥昔单抗和派姆单抗治疗难治性微卫星稳定转移性结直肠癌患者的 II 期研究（安全磨合）
该 2 期临床研究将评估 ALX148 联合西妥昔单抗和派姆单抗治疗难治性微卫星稳定性转移性结直肠癌
研究概览
详细说明
这是一项开放标签、多中心、单组 II 期临床试验（具有安全性试验），评估 ALX148、西妥昔单抗和派姆单抗联合治疗至少 2 个月后进展的转移性微卫星稳定性结直肠癌患者系统治疗线。
一部分患者将接受与研究相关的活检。
将有一个安全磨合阶段，然后是剂量扩展阶段。
根据 RECIST v1.1，两个阶段的患者将继续接受研究治疗直至疾病进展。
研究类型
介入性
注册 (实际的)
19
阶段
- 阶段2
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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Arizona
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Tucson、Arizona、美国、85724
- University of Arizona Cancer Center
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado Cancer Center
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New Jersey
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New Brunswick、New Jersey、美国、08903
- Rutgers Cancer insititute
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Virginia
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Fairfax、Virginia、美国、22031
- Inova Schar Cancer Institute
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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 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
要有资格参与本研究，个人必须满足以下所有条件：
- 诊断为转移性结直肠癌，之前接受过至少两线不可切除/转移性疾病的治疗
- 有微卫星稳定疾病
- 足够的血液学和终末器官功能
排除标准：
符合以下任何标准的个人将被排除在参与本研究之外：
- 已知 MSI 高状态或已知错配修复缺陷 (dMMR) 的患者
- 错配修复和微卫星稳定性状态均未知的患者
- 对任何研究药物或其类别的严重过敏、过敏或其他超敏反应史
- 未使用过 EGFR 抑制剂的左侧（脾曲处或远端）RAS/BRAF 野生型转移性结直肠癌。
- 先前使用抗 PD-1、抗 PD-L1、抗 PD L2、抗 CD47 或抗 SIRPα 药物或针对另一种刺激性或共抑制性 T 细胞受体（例如，CTLA- 4, 牛 40, CD137)
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：非随机化
- 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：Stage 1: Safety run-in evaluating evorpacept at 15 mg/kg weekly
Doses:
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ⅣQW
其他名称：
IV Q3W
其他名称：
ⅣQW
其他名称：
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实验性的：Stage 1: Safety run-in evaluating evorpacept at 10 mg/kg weekly
Doses:
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ⅣQW
其他名称：
IV Q3W
其他名称：
ⅣQW
其他名称：
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实验性的：Stage 2: Expansion cohort using recommended dose (RD) of evorpacept
Doses:
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ⅣQW
其他名称：
IV Q3W
其他名称：
ⅣQW
其他名称：
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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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Objective Response Rate (ORR)
大体时间：The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)
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A patient is considered to be an objective responder if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR) or partial response (PR) per RECIST v1.1.
ORR is defined as the proportion of patients who were classified as objective responders.
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The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)
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Determine the Recommended Dose (RD) of Evorpacept (ALX148) in Combination With Cetuximab and Pembrolizumab
大体时间：During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.
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The recommended dose (RD) of evorpacept was determined by evaluating the totality of the first-cycle clinical data.
Rules to determine the RD based on the number of patients experiencing a dose-limiting toxicity (DLT) were defined in the protocol.
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During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Duration Of Response (DOR)
大体时间：From date of 1st response (CR or PR) until either progression (PD or death) or censoring date
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DOR is defined as the length of time (months) from the 1st response (CR or PR per RECIST v1.1) until either the first observation of progressive disease (PD) or death from any cause.
Patients who did not experience PD or die are considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
This is a subgroup analysis, consisting of all patients who experienced response (CR or PR per RECIST v1.1)
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From date of 1st response (CR or PR) until either progression (PD or death) or censoring date
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Progression-Free Survival (PFS)
大体时间：For each subject, from enrollment until the end of their months-to-progression (as defined above)
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Months-to-Progression is defined as the length of time (in months) from enrollment until either the first observation of progressive disease (PD) using RECIST v1.1 or death from any cause.
Patients who did not have PD or die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
PFS is a survival analysis involving both the binary endpoint of whether or not each patient progressed or not (i.e. were censored), and the months-to-progression times for each patient.
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For each subject, from enrollment until the end of their months-to-progression (as defined above)
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Overall Survival (OS)
大体时间：For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
Months-to-death is defined as the number of months from enrollment until death from any cause.
Subjects who did not die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
OS is a survival analysis involving both the binary endpoint of whether or not each patient died or not, and the months-to-death times for each patient.
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For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
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Disease Control Rate (DCR)
大体时间：The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
A patient is classified as 'Disease Controlled' if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.
DCR is defined as the proportion of patients who were classified as 'Disease Controlled'.
|
The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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PFS - Response-Evaluable Population
大体时间：For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
Months-to-Progression is defined as the length of time (in months) from enrollment until either the first observation of progressive disease (PD) using RECIST v1.1 or death from any cause.
Patients who did not have PD or die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
PFS is a survival analysis involving both the binary endpoint of whether or not each patient progressed or not (i.e. were censored), and the months-to-progression times for each patient.
|
For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
|
OS - Response-Evaluable Population
大体时间：For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
Months-to-death is defined as the number of months from enrollment until death from any cause.
Subjects who did not die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
OS is a survival analysis involving both the binary endpoint of whether or not each patient died or not, and the months-to-death times for each patient.
|
For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
|
ORR - Response-Evaluable Population
大体时间：The duration of time during which tumor assessments were performed for each patient, until they experience disease progression. The latest timepoint an assessment was performed was at Cycle 21 Day 15 (14.5 mo after informed consent).
|
A patient is considered to be an objective responder if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR) or partial response (PR) per RECIST v1.1.
ORR is defined as the proportion of patients who were classified as objective responders.
|
The duration of time during which tumor assessments were performed for each patient, until they experience disease progression. The latest timepoint an assessment was performed was at Cycle 21 Day 15 (14.5 mo after informed consent).
|
|
DCR - Response-Evaluable Population
大体时间：The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
A patient is classified as 'Disease Controlled' if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.
DCR is defined as the proportion of patients who were classified as 'Disease Controlled'.
|
The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Wells Messersmith, MD、University of Colorado, Denver
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)
2022年7月28日
初级完成 (实际的)
2024年10月30日
研究完成 (实际的)
2024年10月30日
研究注册日期
首次提交
2021年9月27日
首先提交符合 QC 标准的
2021年12月9日
首次发布 (实际的)
2021年12月22日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年8月12日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 22-0110.cc
- AGICC-ALX148 21CRC01 (其他标识符：AGICC)
- NCI-2022-02019 (其他赠款/资助编号：CTRP)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
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