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| ID | Type | Description | Link |
|---|---|---|---|
| CMAB009 | Registry Identifier | 2007L02499 |
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| Name | Class |
|---|---|
| Shanghai Biomabs Pharmaceutical Co., Ltd. | INDUSTRY |
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The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients
CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is expressed by Chinese hamster ovary cells. It has the same amino acid sequence as cetuximab (C225, Erbitux®) , but it has slightly different abilities for glycosylation and other post-translational modifications, and it is developed by Shanghai Zhangjiang Biotechnology Limited Company and produced by Biomabs. Phase I study results suggest that CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter, open-label study was to determine whether adding CMAB009 to irinotecan increased the response rate and prolongs survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMAB009 plus Irinotecan | Experimental |
| |
| Irinotecan-only and sequential-CMAB009 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMAB009 plus Irinotecan | Drug | Combined with irinotecan 180 mg/m2 every 2 weeks, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Tumor response was evaluated every 6 weeks and confirmed at least 4 weeks later | Time to progression, assessed up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | The study was designed to evaluate the PFS as second end point, progression-free survival is defined as the period from date of randomization to date of disease progression | Time to progression, assessed up to two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Study Chair |
| B C Mei | Peking Union Medical College Hospital | Principal Investigator |
| B Li | Chinese PLA Affiliated Central Hospital | Principal Investigator |
| X J Ming | Affiliated Hospital of Chinese PLA Military Academy of Medical Science | Principal Investigator |
| B Yi | TianJin Medical University Affiliated Cancer Hospital | Principal Investigator |
| Y Qiang | NanKai University Affiliated Hospital | Principal Investigator |
| L Wei | HeBei Medical University Fouth Hospital | Principal Investigator |
| L Y Peng | Chinese Medical University First Affiliated Hospital | Principal Investigator |
| W B Cheng | Jinan Military Central Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31126331 | Derived | Shi Y, Li J, Xu J, Sun Y, Wang L, Cheng Y, Liu W, Sun G, Chen Y, Bai L, Zhang Y, He X, Luo Y, Wang Z, Liu Y, Yao Q, Li Y, Qin S, Hu X, Bi F, Zheng R, Ouyang X. CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients: promising findings from a prospective, open-label, randomized, phase III trial. Cancer Commun (Lond). 2019 May 24;39(1):28. doi: 10.1186/s40880-019-0374-8. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 8, 2021 | |
| Reset | Nov 4, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 8, 2021 | Nov 4, 2021 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C559688 | CMAB009 |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Irinotecan-only and sequential-CMAB009 | Drug | First, irinotecan 180 mg/m2 every 2 weeks till PD occured, discontinue it; then, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression. |
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| W Z Hai | Shandong Provincal Cancer Hospital | Principal Investigator |
| Y S Ying | Tongji Medical College of Huazhong University of Science and Technology | Principal Investigator |
| L Yi | Hunan Provincal Cancer Hospital | Principal Investigator |
| C Y Gui | Fujian Provincal Cancer Hospital | Principal Investigator |
| W L Wei | Shanghai Jiaotong University Affiliated First People's Hospital | Principal Investigator |
| Z Jun | Shanghai Jiaotong University Affiliated Ruijin Hospital | Principal Investigator |
| H C Hong | Central South University | Principal Investigator |
| OY Xuenong | Fuzhou Central Hospital of Nanjing Military Command | Principal Investigator |
| L Jin | Fudan University Affiliated Cancer Hospital | Principal Investigator |
| Z Y Ping | Zhejiang Provincal Cancer Hospital | Principal Investigator |
| H X Hua | Guangxi Medical University Affiliated Cancer Hospital | Principal Investigator |
| L R Cheng | Nanfang Medical University Affiliated Nanfang Hospital | Principal Investigator |
| L Y Hong | Zhongshan University Affliated Cancer Hospital | Principal Investigator |
| T Min | Suzhou University Affiliated First Hospital | Principal Investigator |
| Z Z Xiang | Suzhou University Affiliated Second Hospital | Principal Investigator |
| C Ying | Jilin Provincal Cancer Hospital | Principal Investigator |
| F J Feng | Jiangsu Provincal Cancer Hospital | Principal Investigator |
| Q S Qui | Chinese PLA Affiliated 81 Hospital | Principal Investigator |
| J Bin | Shanghai Jiaotong University Affiliated Third People's Hospital | Principal Investigator |
| Z R Sheng | The First Affiliated Hospital of Bengbu Medical University | Principal Investigator |
| M G Xin | Nantong Medical College Affiliated Hospital | Principal Investigator |
| S G Ping | Anhui Medical University Affiliated First Hospital | Principal Investigator |
| D W Chao | The Fourth Military University Affiliated First Hospital | Principal Investigator |
| L H Jie | The Third Military University Affiliated First Hospital | Principal Investigator |
| X Ying | Chongqing University Cancer Hospital | Principal Investigator |
| F Min | Chongqing First People's Hospital | Principal Investigator |
| B Feng | Sichuan University Huaxi Hospital | Principal Investigator |
| W D Lin | Sichuan Provincal People's Hospital | Principal Investigator |
| Z W Hua | Gansu Provincal Cancer Hospital | Principal Investigator |
| C Hong | Kunming Central Hospital of Chengdu Military Command | Principal Investigator |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |