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A Clinical Study of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in the Treatment of Advanced Colorectal Cancer

2026年6月12日 更新者：Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Colorectal Cancer

To assess the safety and preliminary efficacy of TQB2930 and chemotherapy with or without bevacizumab in subjects with HER2-positive unresectable locally advanced or metastatic colorectal cancer (CRC).

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

71

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。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100034
        • Peking University First Hospital
        • 接触：
    • Gansu
      • Lanzhou、Gansu、中国、730050
        • Gansu Provincial Tumor Hospital
        • 接触：
    • Guangxi
      • Nanning、Guangxi、中国、530000
        • Guangxi Zhuang Autonomous Region Cancer Hospital
        • 接触：
    • Guizhou
      • Zunyi、Guizhou、中国、563000
        • The Affiliated Hospital of Zunyi Medical University
        • 接触：
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150000
        • Harbin Medical University Cancer Hospital
        • 接触：
        • 接触：
    • Henan
      • Zhengzhou、Henan、中国、450000
        • The First Affiliated Hospital of Zhengzhou University
        • 接触：
      • Zhengzhou、Henan、中国、450000
        • Henan Cancer Hospital
        • 接触：
      • Zhengzhou、Henan、中国、450000
        • The Third People's Hospital of Zhengzhou
        • 接触：
    • Hubei
      • Jingzhou、Hubei、中国、434099
        • Jingzhou First People's Hospital
        • 接触：
      • Wuhan、Hubei、中国、430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 接触：
    • Hunan
      • Changsha、Hunan、中国、410013
        • Hunan Cancer Hospital
        • 接触：
    • Jiangsu
      • Nanjing、Jiangsu、中国、210009
        • Zhongda Hospital Southeast University
        • 接触：
      • Nanjing、Jiangsu、中国、210000
        • Jiangsu Provincial Cancer Hospital
        • 接触：
    • Jilin
      • Changchun、Jilin、中国、130021
        • The First Hospital of Jilin University
        • 接触：
      • Changchun、Jilin、中国、130021
        • Jilin cancer hospital
        • 接触：
    • Liaoning
      • Shenyang、Liaoning、中国、110000
        • Liaoning Cancer Hospital & Institute
        • 接触：
    • Shaanxi
      • Xi'an、Shaanxi、中国、710000
        • The First Affiliated Hospital of Xi'an Jiaotong University Medical College
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200127
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • 接触：
    • Shanxi
      • Xi’an、Shanxi、中国、710000
        • The Second Affiliated Hospital of Air Force Medical University
        • 接触：
      • Xi’an、Shanxi、中国、710000
        • The First Affiliated Hospital of Air Force Medical University
        • 接触：
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300121
        • Tianjin Union Medical Center
        • 接触：
          • Mingqing Zhang, Doctor
          • 电话号码：15122875158
          • 邮箱：zmq1003@163.com
      • Tianjin、Tianjin Municipality、中国、300202
        • Tianjin Medical University Cancer Institute & Hospital
        • 接触：
    • Xinjiang
      • Ürümqi、Xinjiang、中国、830054
        • Xinjiang Medical University Affiliated Tumor Hospital
        • 接触：
    • Zhejiang
      • Lishui、Zhejiang、中国、323000
        • Lishui Municipal Central Hospital
        • 接触：

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance
  • Age: 18-75 years (including the boundary when signing the informed consent form)
  • Eastern Cooperative Oncology Group (ECOG) score: 0-1
  • Expected survival of more than 3 months
  • Unresectable locally advanced or metastatic colorectal cancer diagnosed by histopathology/cytology
  • HER2 positive tested
  • Presence of at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Subjects should agree to use contraception during the study and for 6 months after the end

Exclusion Criteria:

  • Patients with previously confirmed Microsatellite Instability Microsatellite Instability-High Deficient Mismatch Repair (MSI-H/dMMR)
  • Presence of conditions affecting intravenous, venous blood sampling, or multiple factors affecting oral medications
  • Active inflammatory bowel disease within 28 days prior to first dose
  • Other malignancies within 5 years prior to the first dose or currently suffering from other malignancies
  • Unresolved toxicity greater than CTCAE Grade 1 due to any prior therapy
  • Major surgical treatment, significant traumatic injury within 28 days prior to the first dose or anticipation of major surgery during study treatment
  • Had wounds or fractures that had not been healed for a long time
  • Cerebrovascular accident, deep venous thrombosis and pulmonary embolism within 6 months prior to the first dose
  • Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders
  • Subjects with any severe and/or uncontrolled disease
  • Known tumor-related carcinomatous meningitis with symptoms of brain metastases or symptom control for less than 4 weeks
  • Patients with imaging suggestive of tumor invasion of major blood vessels or fatal massive hemorrhage due to tumor rupture or invasion of major blood vessels judged by the investigator to be very likely to occur during the study
  • Failure to control serous effusions requiring repeated drainage
  • Local radiotherapy or 4. Bone marrow irradiation > 30% for bone metastasis before the first medication
  • Known tumor-related spinal cord compression, weight-bearing bone pathological fracture, extensive bone metastasis, or uncontrollable tumor bone metastasis-related pain
  • Patients who have received chemotherapy, targeted therapy, immunotherapy or other systemic anti-tumor drug therapy before the first medication;
  • Received Chinese patent medicine treatment with anti-tumor indications in the package insert of National Medical Products Administration (NMPA) approved drugs before study treatment
  • History of live attenuated vaccination before the first dose or planned live attenuated vaccination during the study;
  • Previous history of severe allergy of unknown origin
  • According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or the subject is considered unsuitable for other reasons

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：并行分配
  • 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：TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection
药品：TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection
TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting ECD2 and ECD4, two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. Bevacizumab blocks Vascular Endothelial Growth Factor (VEGF) binding to receptors and inhibits tumor angiogenesis.
有源比较器：TQB2930 injection + Oxaliplatin injection + Capecitabine tablets
药品：TQB2930 injection + Oxaliplatin injection + Capecitabine tablets
TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting Extracellular Domain 2 (ECD2) and Extracellular Domain 4 (ECD4), two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis.

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
Recommended Phase 2 Dose
大体时间：Baseline up to 21 days
It refers to the safe and effective dose range that can be used for phase II study determined through phase I clinical trial.
Baseline up to 21 days
Adverse event (AE)
大体时间：From the subject's signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first)
Incidence and severity of adverse events.
From the subject's signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first)
Objective Response Rate
大体时间：Baseline up to 24 months
The proportion of patients achieving complete response and partial response among the total evaluable cases.
Baseline up to 24 months

次要结果测量

结果测量
措施说明
大体时间
Half-life
大体时间：Baseline up to 24 months
The time it takes for the concentration of a drug in the body (usually the plasma concentration) to decrease to half of its initial value.
Baseline up to 24 months
Plasma concentration-time profiles
大体时间：Baseline up to 24 months
Total area covered under the curve plotted with time as X-axis and plasma concentration as Y-axis.
Baseline up to 24 months
Apparent clearance
大体时间：Baseline up to 24 months
The rate at which the drug is cleared from the body.
Baseline up to 24 months
Apparent terminal volume of distribution
大体时间：Baseline up to 24 months
Describe the drug distribution in the body.
Baseline up to 24 months
Trough plasma concentration
大体时间：Baseline up to 24 months
Minimum plasma drug concentration level at the end of the dosing interval (before the next dosing).
Baseline up to 24 months
Disease Control Rate
大体时间：Baseline up to 24 months
The percentage of subjects with a complete response, partial response, or stable disease as determined by RECIST 1.1.
Baseline up to 24 months
Duration Of Response
大体时间：Baseline up to 24 months
The time from the first assessment of the tumor as a complete response or partial response to the first occurrence of disease progression or death from any cause.
Baseline up to 24 months
Progression Free Survival
大体时间：Baseline up to 24 months
Progression Free Survival (PFS) is defined as the length of time from the start of treatment until the disease progresses or the patient dies from any cause.
Baseline up to 24 months
Overall Survival
大体时间：Baseline up to 24 months
The time from the start of initial treatment to death from any cause.
Baseline up to 24 months
Anti-Drug Antibodies (ADA) incidence
大体时间：Baseline up to 24 months
Proportion of anti-drug antibody produced in the population of patients using the drug.
Baseline up to 24 months

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

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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 (估计的)

2026年7月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年6月12日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年5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

  • TQB2930-Ib/II-02

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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