一项研究CEA-PRIT 2.0在转移性结直肠癌（mCRC）患者中的临床试验
一项评估CEA预靶向212Pb疗法在转移性结直肠癌参与者中的剂量测定、安全性、耐受性、药代动力学、药效学及临床活性的I期、开放标签、剂量递增和扩展研究
This study will evaluate the dosimetry, safety, efficacy, pharmacokinetics (PK), pharmacodynamics and immunogenicity of CEA-PRIT 2.0 in participants with metastatic microsatellite-stable (MSS) mCRC who are intolerant to or have progressed after having received available standard-of-care (SOC) therapies.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究联系人备份
- 姓名：Reference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below.
- 电话号码：888-662-6728 (U.S. and Canada)
- 邮箱：global-roche-genentech-trials@gene.com
学习地点
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Illinois
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Chicago、Illinois、美国、60637-1426
- 招聘中
- The University of Chicago Medical Center
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Missouri
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St Louis、Missouri、美国、63110-1010
- 招聘中
- Washington University School of Medicine in St. Louis
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Nebraska
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Omaha、Nebraska、美国、68130
- 招聘中
- Nebraska Cancer Specialists
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Texas
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Houston、Texas、美国、77030
- 招聘中
- MD Anderson Cancer Center
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Wisconsin
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Madison、Wisconsin、美国、53792
- 招聘中
- Univ of Wisconsin-Madison
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically confirmed adenocarcinoma originating from the colon or rectum
- Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7)
- Confirmed MSS and/or proficient mismatch repair (MMR) status
- Experienced disease progression during or within 3 months following the last administration of systemic anti-cancer therapies for metastatic disease
- Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Life expectancy estimated by the Investigator to be >=12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
- Adequate cardiovascular, hematological and renal function and laboratory parameters
Exclusion Criteria:
- Pregnant or breastfeeding or intending to become pregnant
- Participants with active central nervous system (CNS) metastases
- History of malignancy other than the one under investigation
- Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted therapy or surgical procedure
- Major surgery or significant traumatic injury <4 weeks prior to the first CEA-PRIT 2.0 administration (excluding biopsies) or anticipation of the need for major surgery during study treatment
- Participants have a known confirmed positive test for HIV
- Positive hepatitis B surface antigen (HBsAg) test, and/or positive total hepatitis B core Ab (HBcAb) test at screening.
- Positive hepatitis C (HCV) Ab test result at screening
- Any anticancer treatment or any investigational agent within 4 weeks (or 5 times the half-life, whichever is shorter) prior to C1D1
- Prior treatment with a CEA-targeted agent or systemic radio therapy
学习计划
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：Part 1 (Dosimetry)
Participants will receive SeParated v-domains LInkage Technology Antibodies (SPLIT Abs) administered intravenously (IV). During Cycle 1, following an initial dosing interval, participants will receive 203Pb-DOTAM for imaging-based dosimetry assessment, followed by administration of 212Pb-DOTAM. In other cycles, participants will receive SPLIT Abs in combination with 212Pb-DOTAM only. Treatment will be administered every 4 weeks (Q4W) for up to 6 cycles. Each cycle is 28 days. |
Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
其他名称：
Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
其他名称：
Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
其他名称：
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实验性的：Part 2 (212Pb-DOTAM Administered Activity Escalation)
Participants will receive SPLIT Abs at the dose and dosing interval selected in Part 1 in combination with 212Pb-DOTAM. The administered activity of 212Pb-DOTAM will be increased stepwise in each cohort to identify the maximum tolerated administered 212 activity (MTA) or a recommended Phase 2 administered activity (RP2A). |
Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
其他名称：
Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
其他名称：
Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
其他名称：
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实验性的：Part 3 (Expansion)
Participants will receive SPLIT Abs in combination with 212Pb-DOTAM at the RP2A identified based on results from Parts 1 and 2. |
Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
其他名称：
Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
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 |
大体时间 |
|---|---|
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第1部分：SPLIT抗体的血清浓度
大体时间：最长约48周
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最长约48周
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第一部分：203Pb-DOTAM的血液、血浆和尿液放射性时间进程
大体时间：最长约 48 周
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最长约 48 周
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第1至2部分：根据203Pb-DOTAM推算的212Pb-DOTAM吸收辐射剂量
大体时间：最长约48周
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最长约48周
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第1至3部分：出现不良事件（AE）的参与者百分比
大体时间：最长约5年
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最长约5年
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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第1部分（共2部分）：肿瘤与正常组织中203Pb-DOTAM的摄取
大体时间：最多约48周
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最多约48周
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第1部分至第2部分：203Pb-DOTAM的血液、血浆和尿液放射性的时间过程
大体时间：最长约48周
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最长约48周
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第1至3部分：CEA-PRIT 2.0的血清浓度
大体时间：最长约48周
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最长约48周
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第 1 至 3 部分：212Pb-DOTAM 血液和血浆放射性随时间变化过程
大体时间：最多约48周
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最多约48周
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第1至3部分：针对SPLIT抗体产生抗药抗体（ADAs）的参与者百分比
大体时间：基线，最长约48周
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基线，最长约48周
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第1至3部分：客观缓解率 (ORR)
大体时间：最长约48周
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最长约48周
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第 1 至 3 部分：疾病控制率 (DCR)
大体时间：最长约48周
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最长约48周
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第 1 至 3 部分：反应持续时间 (DOR)
大体时间：最长约 48 周
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最长约 48 周
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第1至3部分：无进展生存期（PFS）
大体时间：约48周内
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约48周内
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第 1 至 3 部分：总生存期 (OS)
大体时间：最长约48周
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最长约48周
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第1至3部分：癌胚抗原（CEA）肿瘤表达与临床活性的相关性
大体时间：最长约48周
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最长约48周
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合作者和调查者
调查人员
- 研究主任：Clinical Trials、Hoffmann-La Roche
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.