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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection | Experimental |
| |
| TQB2930 injection + Oxaliplatin injection + Capecitabine tablets | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose | 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) | 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 | The proportion of patients achieving complete response and partial response among the total evaluable cases. | Baseline up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Half-life | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruihua Xu, Doctor | Contact | 020-87343468 | xurh@syscc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
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|
| TQB2930 injection + Oxaliplatin injection + Capecitabine tablets | Drug | 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. |
|
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 | The rate at which the drug is cleared from the body. | Baseline up to 24 months |
| Apparent terminal volume of distribution | Describe the drug distribution in the body. | Baseline up to 24 months |
| Trough plasma concentration | Minimum plasma drug concentration level at the end of the dosing interval (before the next dosing). | Baseline up to 24 months |
| Disease Control Rate | 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 | 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 | 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 | The time from the start of initial treatment to death from any cause. | Baseline up to 24 months |
| Anti-Drug Antibodies (ADA) incidence | Proportion of anti-drug antibody produced in the population of patients using the drug. | Baseline up to 24 months |
| Gansu Provincial Tumor Hospital | Lanzhou | Gansu | 730050 | China |
|
| Guangxi Zhuang Autonomous Region Cancer Hospital | Nanning | Guangxi | 530000 | China |
|
| The Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | 563000 | China |
|
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
|
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
|
| The first affiliated hospital of Zhengzhou university | Zhengzhou | Henan | 450000 | China |
|
| The Third People's Hospital of Zhengzhou | Zhengzhou | Henan | 450000 | China |
|
| Jingzhou First People's Hospital | Jingzhou | Hubei | 434099 | China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
|
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
|
| Jiangsu Provincial Cancer Hospital | Nanjing | Jiangsu | 210000 | China |
|
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210009 | China |
|
| Jilin Cancer Hospital | Changchun | Jilin | 130021 | China |
|
| The first hospital of Jilin University | Changchun | Jilin | 130021 | China |
|
| Liaoning Cancer Hospital & Institute | Shenyang | Liaoning | 110000 | China |
|
| The First Affiliated Hospital of Xi'an Jiaotong University Medical College | Xi'an | Shaanxi | 710000 | China |
|
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
|
| The First Affiliated Hospital of Air Force Medical University | Xi’an | Shanxi | 710000 | China |
|
| The Second Affiliated Hospital of Air Force Medical University | Xi’an | Shanxi | 710000 | China |
|
| Tianjin Union Medical Center | Tianjin | Tianjin Municipality | 300121 | China |
|
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300202 | China |
|
| Xinjiang Medical University Affiliated Tumor Hospital | Ürümqi | Xinjiang | 830054 | China |
|
| Lishui Municipal Central Hospital | Lishui | Zhejiang | 323000 | China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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