{"id":"cmab009-plus-irinotecan","safety":{"commonSideEffects":[{"rate":"30-50%","effect":"Diarrhea"},{"rate":"20-40%","effect":"Fatigue"},{"rate":"20-40%","effect":"Nausea"},{"rate":"10-30%","effect":"Vomiting"},{"rate":"10-30%","effect":"Neutropenia"},{"rate":"5-20%","effect":"Leukopenia"},{"rate":"5-20%","effect":"Anemia"},{"rate":"5-20%","effect":"Thrombocytopenia"}]},"_chembl":{"chemblId":"CHEMBL3989514","moleculeType":"Small molecule","molecularWeight":"677.19"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"CMAB009 works by binding to PD-1 and blocking its interaction with PD-L1, thereby enhancing T-cell activation and anti-tumor response. Irinotecan works by inhibiting topoisomerase I, an enzyme involved in DNA replication, leading to DNA damage and apoptosis in rapidly dividing cancer cells.","oneSentence":"CMAB009 is a PD-1 inhibitor, and Irinotecan is a topoisomerase I inhibitor.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T02:31:24.964Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic colorectal cancer"}]},"trialDetails":[{"nctId":"NCT05863195","phase":"PHASE3","title":"Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial","status":"RECRUITING","sponsor":"ECOG-ACRIN Cancer Research Group","startDate":"2023-10-19","conditions":"Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Stage IV Colorectal Cancer AJCC v8","enrollment":408},{"nctId":"NCT03290937","phase":"PHASE1","title":"Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2017-12-27","conditions":"Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8","enrollment":34},{"nctId":"NCT01787500","phase":"PHASE1","title":"Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2013-02-15","conditions":"BRAF NP_004324.2:p.V600X, KRAS wt Allele, Metastatic Malignant Solid Neoplasm","enrollment":33},{"nctId":"NCT03206151","phase":"PHASE3","title":"CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer","status":"COMPLETED","sponsor":"Taizhou Mabtech Pharmaceutical Co.,Ltd","startDate":"2017-12-12","conditions":"Metastatic Colorectal Cancer","enrollment":520},{"nctId":"NCT04117945","phase":"PHASE2","title":"Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Academic and Community Cancer Research United","startDate":"2020-03-03","conditions":"BRAF V600E Negative, KRAS Gene Mutation Negative, Locally Advanced Unresectable Colorectal Adenocarcinoma","enrollment":22},{"nctId":"NCT02292758","phase":"PHASE2","title":"Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery","status":"COMPLETED","sponsor":"Academic and Community Cancer Research United","startDate":"2014-12-12","conditions":"Colorectal Adenocarcinoma, RAS Wild Type, Stage IV Colorectal Cancer AJCC v7","enrollment":36},{"nctId":"NCT01550055","phase":"PHASE2, PHASE3","title":"Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer","status":"COMPLETED","sponsor":"Shanghai Zhangjiang Biotechnology Limited Company","startDate":"2009-05-31","conditions":"Metastatic Colorectal Cancer","enrollment":512}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["YiMaiLin for irinotecan"],"phase":"phase_2","status":"active","brandName":"CMAB009 plus Irinotecan","genericName":"CMAB009 plus Irinotecan","companyName":"Shanghai Zhangjiang Biotechnology Limited Company","companyId":"shanghai-zhangjiang-biotechnology-limited-company","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CMAB009 is a small molecule inhibitor of DNA topoisomerase 1. It is being studied in combination with Irinotecan, a DNA topoisomerase 1 inhibitor, for the treatment of metastatic colorectal cancer, specifically in patients with KRAS wild-type tumors.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}