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TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in locally advanced or metastatic non-small cell lung cancer with HER2 gene abnormality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2102 for injection | Experimental | Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle. |
|
| TQB2102 for injection+Benmelstobart injection | Experimental | TQB2102 for injection, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle; Benmelstobart injection, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2102 for injection | Drug | HER2 dual-antibody-drug Conjugate (ADC). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR defined as percentage of participants achieving complete response (CR) and partial response (PR). | Baseline up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration Of Remission (DOR) | DOR defined as the time when the participants first achieved complete or partial remission to disease progression. | Baseline up to 8 months |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, Doctor | Contact | 020-87343458 | Zhangli6@mail.sysu.edu.cn | |
| Qiming Wang, Doctor | Contact | 13783590691 | qimingwang1006@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
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| TQB2102 for injection combined with Benmelstobart injection |
| Drug |
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC); Benmelstobart injection is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1). |
|
PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.
| Baseline up to 8 months |
| Overall Survival (OS) | OS defined as the time from the first injection to death from any cause. | Baseline up to 18 months |
| Frequency of adverse event (AE) | The occurrence of all adverse medical events after the first injection. | From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first. |
| Severity of adverse event (AE) | The severity of all adverse medical events after the first injection. | From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first. |
| Anti-drug antibody (ADA) | Incidence of anti-drug antibody (ADA) | Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days), 90 days after the end of the last infusion (each cycle is 21 days). |
| Foshan First People's Hospital | Not yet recruiting | Foshan | Guangdong | 528000 | China |
|
| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
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| Jiangmen Central Hospital | Not yet recruiting | Jiangmen | Guangdong | 529000 | China |
|
| The Second People's Hospital of Shenzhen | Not yet recruiting | Shenzhen | Guangdong | 518035 | China |
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| Guangxi Medical University Cancer Hospital | Not yet recruiting | Nanning | Guangxi | 53000 | China |
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| The Second Affiliated Hospital of Zunyi Medical University | Not yet recruiting | Zunyi | Guizhou | 563006 | China |
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| Harbin Medical University cancer hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| Hunan Provincial Tumor Hospital | Not yet recruiting | Changsha | Hunan | 410031 | China |
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| Jiangsu Provincial People's Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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| First Affiliated Hospital of Gannan Medical University | Not yet recruiting | Ganzhou | Jiangxi | 341099 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| Jilin Cancer Hospital | Not yet recruiting | Changchun | Jilin | 130012 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710000 | China |
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| Affiliated Cancer Hospital of Shandong First Medical University | Not yet recruiting | Jinan | Shandong | 250117 | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| Sichuan Cancer Hospital | Not yet recruiting | Chengdu | Sichuan | 610040 | China |
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| Leshan People's Hospital | Not yet recruiting | Leshan | Sichuan | 614099 | China |
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| Xinjiang Uygur Autonomous Region Cancer Hospital | Not yet recruiting | Ürümqi | Xinjiang | 830001 | China |
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| The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU | Not yet recruiting | Wenzhou | Zhejiang | 325015 | China |
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| Beijing Cancer Hospital | Not yet recruiting | Beijing | 100142 | China |
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| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | 200032 | China |
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| Tianjin Medical University Cancer Institute&Hpspital | Not yet recruiting | Tianjin | 300181 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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