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MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors

2022年3月7日 更新者：Merck KGaA, Darmstadt, Germany

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications in Asia

The main purpose of this study is assess the safety and tolerability of MSB0011359C. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or a standard therapy has failed.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

114

阶段

  • 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

  • 台湾
      • Tainan、台湾
        • National Cheng Kung University Hospital
      • Taipei、台湾
        • Mackay Memorial Hospital
      • Taipei、台湾
        • National Taiwan University Hospital
      • Taoyuan、台湾
        • Chang Gung Memorial Hospital; Linkou
  • 大韩民国
      • Seoul、大韩民国
        • Seoul National University Hospital
      • Seoul、大韩民国
        • Asan Medical Center
      • Seoul、大韩民国
        • Severance Hospital
  • 日本
      • Fukuoka、日本
        • NHO Kyushu Cancer Center
      • Kashiwa、日本
        • National Cancer Center East, Department of Experimental Therapeutics
      • Kashiwa、日本
        • National Cancer Center East, Department of hepatobiliary and pancreatic oncology
      • Kitaadachi-gun、日本
        • Saitama Cancer Center
      • Matsuyama、日本
        • NHO Shikoku Cancer Center
      • Nagoya、日本
        • Aichi Cancer Center Hospital
      • Osakasayama、日本
        • Kinki University Hospital
      • Tokyo、日本
        • National Cancer Center, Department of Experimental Therapeutics
      • Tokyo、日本
        • National Cancer Center, Department of hepatobiliary and pancreatic oncology
      • Yokohama、日本
        • Kanagawa Cancer Center, Department of Gastroenterology
      • Yokohama、日本
        • Kanagawa Cancer Center, Department of Gastrointestinal Surgery

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

20年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Able and willing to give written informed consent and has signed the appropriate written informed consent form (ICF), prior to performance of any trial activities
  • Eligible male and female subjects aged greater than or equal to (>=)20 years
  • Histologically or cytologically proven metastatic or locally advanced solid tumors, for which no effective standard therapy exists or standard therapy has failed
  • Eastern Cooperative Oncology Group performance status (ECOG) performance status of 0 to 1 at trial entry
  • Life expectancy >=12 weeks as judged by the Investigator.
  • Adequate hematological function defined by white blood cell (WBC) count >=3*10^9/Liter with absolute neutrophil count (ANC) >=1.5*10^9/Liter, lymphocyte count >=0.5* 10^9/Liter, platelet count >=75*10^9/Liter, and Hemoglobin (Hgb) >= 9 grams per deciliter (g/dL) (in absence of blood transfusion).
  • Adequate hepatic function defined by a total bilirubin level <=1.5 × Upper limit of normal (ULN), an AST level <= 2.5 × ULN, and an ALT level <= 2.5 × ULN.
  • Adequate renal function defined by an estimated creatinine clearance >50 milliliter per minute (mL/min) according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24 hour urine collection.

Other protocol-defined exclusion criteria could apply.

Exclusion Criteria:

  • Concurrent treatment with non-permitted drugs and other interventions
  • Anticancer treatment within 28 days before the start of trial treatment, for example cyto reductive therapy, radiotherapy (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy
  • Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy)
  • Systemic therapy with immunosuppressive agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment
  • Previous malignant disease other than the target malignancy to be investigated in this trial with the exception of cervical carcinoma in situ and superficial or non invasive bladder cancer (treated with curative intent) within the last 5 years or basal cell or squamous cell carcinoma in situ within the last 3 years
  • Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures
  • Active or history of central nervous system metastases, except as in the melanoma-specific Central nervous system (CNS) criteria listed above
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (eg, corneal transplant, hair transplant)

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：MSB0011359C (M7824)
药品：MSB0011359C
Subjects with metastatic or locally advanced solid tumors will receive intravenous infusion of MSB0011359C over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
其他名称：
  • M7824

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
Number of subjects with DLT (Dose limiting Toxicity): dose escalation part
大体时间：Baseline up to Week 3
A DLT is defined as any grade greater than or equal to (>=) 3 adverse event suspected to be related to investigational medicinal product (IMP) by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment.
Baseline up to Week 3
Number of Subjects with treatment-emergent adverse events (TEAEs)
大体时间：First trial drug administration up to 30 days after the last drug administration assessed up to 2 years
An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AEs (SAEs and non-SAEs) will be considered TEAEs when emerging on treatment period defined as the time from the first trial drug administration up to 30 days after the last drug administration date or the earliest date of subsequent anticancer drug therapy minus 1 day, whichever occurs first, unless otherwise stated.
First trial drug administration up to 30 days after the last drug administration assessed up to 2 years
Number of subjects with treatment-related Adverse Events (AE)
大体时间：First trial drug administration up to 30 days after the last drug administration assessed up to 2 years
Treatment related AEs are any untoward medical occurrence in a subject who received study drug with causal relationship with the investigational product as assessed by the investigator.
First trial drug administration up to 30 days after the last drug administration assessed up to 2 years

次要结果测量

结果测量
措施说明
大体时间
Maximum serum concentration (Cmax) of MSB0011359C
大体时间：Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Minimum serum concentration (Cmin) of MSB0011359C
大体时间：Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Area under the concentration time curve from zero to last sampling time (AUC0-t) of MSB0011359C
大体时间：Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Area under the concentration time curve from time zero to infinity (AUC0-inf) of MSB0011359C
大体时间：Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Terminal half life (t1/2) of MSB0011359C
大体时间：Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Serum titers of anti-MSB0011359C antibodies
大体时间：Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years
Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years
Best Overall Response (BOR) as assessed by investigator: Dose escalation part
大体时间：Date of randomization up to 2 years
BOR will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. BOR is defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.
Date of randomization up to 2 years
Best Overall Response (BOR) as assessed by investigator: Expansion part
大体时间：Date of randomization up to 2 years
BOR will be assessed by investigator according to RECIST Version 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Date of randomization up to 2 years
Best Overall Response (BOR) as assessed by Independent Endpoint Review Committee (IRC): Expansion part
大体时间：Date of randomization up to 2 years
The BOR per Independent Endpoint Review Committee (IRC) adjudication will be determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Date of randomization up to 2 years
Duration of response
大体时间：Date of randomization up to 2 years
Time from first assessment of CR to disease progression or death, for TLs, CR was defined as the disappearance of all TLs
Date of randomization up to 2 years
Disease control rate
大体时间：Date of randomization up to 2 years
The disease control rate is defined as the percentage of subjects with BOR. The BOR per IRC adjudication will be determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Date of randomization up to 2 years
Progression Free survival (PFS) time
大体时间：Date of randomization until death or progressive disease assessed up to 2 years
PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS will be assessed as RECIST v1.1 as adjudicated by IRC. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Date of randomization until death or progressive disease assessed up to 2 years
Overall Survival (OS) time
大体时间：Date of randomization until death assessed up to 2 years
OS is defined as the time from randomization to death due to any cause.
Date of randomization until death assessed up to 2 years

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。

赞助

Merck KGaA, Darmstadt, Germany

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。

一般刊物

有用的网址

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)

2016年3月11日

初级完成 (实际的)

2022年2月21日

研究完成 (实际的)

2022年2月21日

研究注册日期

首次提交

2016年3月1日

首先提交符合 QC 标准的

2016年3月3日

首次发布 (估计)

2016年3月4日

研究记录更新

最后更新发布 (实际的)

2022年3月21日

上次提交的符合 QC 标准的更新

2022年3月7日

最后验证

2022年3月1日

更多信息

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

  • 200647-0008

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.

实体瘤的临床试验

MSB0011359C的临床试验

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条件

罕见疾病

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膳食补充剂

赞助者/合作者

地点

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