{"id":"kn046","safety":{"commonSideEffects":[{"rate":null,"effect":"Immune-related adverse events (irAEs)"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Elevated liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL4650483","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"KN046 functions as a PD-L1/4-1BB bispecific antibody that bridges tumor cells expressing PD-L1 with T cells expressing 4-1BB. By blocking the PD-L1/PD-1 inhibitory axis while providing costimulatory 4-1BB signaling, it aims to overcome immune checkpoint suppression and amplify T cell activation and proliferation. This dual mechanism is designed to generate stronger anti-tumor immunity compared to single-agent checkpoint inhibitors.","oneSentence":"KN046 is a bispecific antibody that simultaneously engages PD-L1 on tumor cells and 4-1BB on T cells to enhance anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:17:58.291Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic non-small cell lung cancer"},{"name":"Other solid tumors (in clinical development)"}]},"trialDetails":[{"nctId":"NCT05827796","phase":"PHASE1, PHASE2","title":"IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer","status":"RECRUITING","sponsor":"InxMed (Shanghai) Co., Ltd.","startDate":"2022-12-08","conditions":"Pancreatic Cancer","enrollment":70},{"nctId":"NCT06834399","phase":"PHASE2","title":"TATE and KN046 in MCRC","status":"TERMINATED","sponsor":"Zhejiang Raygene Pharmaceuticals Co., 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Hospital & Institute","startDate":"2023-10-25","conditions":"Digestive System Cancers","enrollment":39},{"nctId":"NCT05985109","phase":"PHASE2","title":"KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"Peking University Cancer Hospital & Institute","startDate":"2023-10-26","conditions":"Colorectal Cancer","enrollment":98},{"nctId":"NCT04521179","phase":"PHASE2","title":"Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors","status":"COMPLETED","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","startDate":"2020-12-07","conditions":"HER2-positive Solid Tumors","enrollment":102},{"nctId":"NCT04165993","phase":"PHASE2","title":"Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer","status":"UNKNOWN","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","startDate":"2019-12-31","conditions":"Metastatic Breast 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Locally Advanced or Metastatic Triple-negative Breast Cancer","status":"COMPLETED","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","startDate":"2019-05-30","conditions":"Triple-negative Breast Cancer","enrollment":52},{"nctId":"NCT05001724","phase":"PHASE2, PHASE3","title":"KN046 Plus Lenvatinib in Subject With Advanced Non-Small Cell Lung Cancer in the Failure of Anti-PD-(L)1 Agent","status":"TERMINATED","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","startDate":"2021-10-28","conditions":"Advanced Non-small Cell Lung Cancer","enrollment":16},{"nctId":"NCT03838848","phase":"PHASE2","title":"KN046 in Patients With Advanced Non-small Cell Lung Cancer","status":"TERMINATED","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","startDate":"2019-05-05","conditions":"Stage IV Non-small Cell Lung Cancer","enrollment":120},{"nctId":"NCT04612712","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors","status":"UNKNOWN","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","startDate":"2021-01-19","conditions":"Advanced Gastrointestinal Tumors","enrollment":42},{"nctId":"NCT04601610","phase":"PHASE1, PHASE2","title":"KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma","status":"TERMINATED","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","startDate":"2021-06-07","conditions":"Advanced HCC","enrollment":6},{"nctId":"NCT03925870","phase":"PHASE2","title":"KN046 in Subjects With Late Stage Esophageal Squamous Cell Carcinoma","status":"COMPLETED","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","startDate":"2019-06-21","conditions":"Esophageal Squamous Cell Carcinoma","enrollment":45},{"nctId":"NCT05425602","phase":"PHASE1, PHASE2","title":"A Study of MAX-40279combined With KN046 in Patients With Advanced / Metastatic Solid Tumors","status":"UNKNOWN","sponsor":"Maxinovel Pty., Ltd.","startDate":"2022-07-31","conditions":"Advanced / Metastatic Solid Tumors","enrollment":108},{"nctId":"NCT04474119","phase":"PHASE3","title":"KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer","status":"UNKNOWN","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","startDate":"2020-09-14","conditions":"Squamous Non-small-cell Lung Cancer","enrollment":482},{"nctId":"NCT04054531","phase":"PHASE2","title":"Study of KN046 With Chemotherapy in First Line Advanced NSCLC","status":"UNKNOWN","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","startDate":"2019-09-04","conditions":"Non-small Cell Lung Cancer","enrollment":50},{"nctId":"NCT03927495","phase":"PHASE2","title":"KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma","status":"UNKNOWN","sponsor":"Shanghai Chest Hospital","startDate":"2019-05-22","conditions":"Esophageal Squamous Cell Carcinoma","enrollment":100},{"nctId":"NCT03529526","phase":"PHASE1","title":"Study of the Safety, Tolerability, Pharmacokinetics, 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Used for Advanced or metastatic non-small cell lung cancer, Other solid tumors (in clinical development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":13,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}