{"id":"ak104-iv","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"}]},"_chembl":{"chemblId":"CHEMBL3121562","moleculeType":"Small molecule","molecularWeight":"784.98"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"AK104 functions as a PD-1/TIM-3 bispecific antibody that blocks two inhibitory checkpoints on T cells, thereby relieving immune suppression in the tumor microenvironment. By targeting both PD-1 and TIM-3, the drug aims to overcome resistance to single-checkpoint inhibition and restore robust anti-tumor immunity. 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Duct Adenocarcinoma","enrollment":48},{"nctId":"NCT06074484","phase":"PHASE2","title":"A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer","status":"UNKNOWN","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","startDate":"2023-09-10","conditions":"Muscle Invasive Bladder Carcinoma","enrollment":36},{"nctId":"NCT05990127","phase":"PHASE3","title":"A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Akeso","startDate":"2023-11-14","conditions":"Locally Advanced or Metastatic NSCLC","enrollment":642},{"nctId":"NCT05948449","phase":"PHASE2","title":"To Evaluate the Efficacy and Safety of Cadonilimab With SOX as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.","status":"UNKNOWN","sponsor":"Sichuan University","startDate":"2023-07","conditions":"Gastric 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Combination With Chemotherapy in the First-line Treatment of ESCC","status":"UNKNOWN","sponsor":"Chinese Academy of Medical Sciences","startDate":"2022-10-01","conditions":"Unresectable Esophageal Squamous Cell Carcinoma, Locally Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma","enrollment":80},{"nctId":"NCT05235542","phase":"PHASE1, PHASE2","title":"A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors","status":"UNKNOWN","sponsor":"Akeso","startDate":"2022-07-12","conditions":"Advanced Malignant Tumors","enrollment":130}],"_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":[],"phase":"phase_3","status":"active","brandName":"AK104(IV)","genericName":"AK104(IV)","companyName":"Akeso","companyId":"akeso","modality":"Small molecule","firstApprovalDate":"","aiSummary":"AK104 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TIM-3 on T cells to enhance anti-tumor immune responses. Used for Advanced or metastatic non-small cell lung cancer, Advanced hepatocellular carcinoma, Other advanced solid tumors (in development).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}