{"id":"cs1001-monoclonal-antibody","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CS1001 binds to programmed death ligand 1 (PD-L1) on tumor cells and immune cells, blocking the inhibitory PD-L1/PD-1 axis that tumors exploit to evade immune surveillance. By disrupting this checkpoint interaction, the antibody restores T-cell activation and proliferation, enabling the immune system to recognize and eliminate cancer cells. This mechanism is characteristic of immune checkpoint inhibitors used across multiple solid and hematologic malignancies.","oneSentence":"CS1001 is a monoclonal antibody that blocks PD-L1, preventing its interaction with PD-1 and PD-L2 receptors to enhance anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:45:31.007Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Gastric cancer"},{"name":"Esophageal cancer"}]},"trialDetails":[{"nctId":"NCT03789604","phase":"PHASE3","title":"A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"CStone Pharmaceuticals","startDate":"2018-12-13","conditions":"Non Small Cell Lung Cancer","enrollment":479},{"nctId":"NCT03744403","phase":"PHASE1","title":"A Study of CS1001 in Subjects with Advanced Solid Tumors","status":"COMPLETED","sponsor":"CStone Pharmaceuticals","startDate":"2018-12-04","conditions":"Advanced Solid Tumors","enrollment":24},{"nctId":"NCT03595657","phase":"PHASE2","title":"A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)","status":"COMPLETED","sponsor":"CStone Pharmaceuticals","startDate":"2018-06-12","conditions":"Extranodal Natural Killer/T-Cell Lymphoma","enrollment":80},{"nctId":"NCT04421352","phase":"PHASE1","title":"Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients","status":"COMPLETED","sponsor":"CStone Pharmaceuticals","startDate":"2021-01-12","conditions":"Relapsed Small Cell Lung Cancer","enrollment":11},{"nctId":"NCT03802591","phase":"PHASE3","title":"A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma","status":"COMPLETED","sponsor":"CStone Pharmaceuticals","startDate":"2019-03-28","conditions":"Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma","enrollment":479},{"nctId":"NCT03728556","phase":"PHASE3","title":"A Study of CS1001 in Subjects With Stage III Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"CStone Pharmaceuticals","startDate":"2018-10-26","conditions":"Non-Small Cell Lung Cancer Stage III","enrollment":381},{"nctId":"NCT03505996","phase":"PHASE2","title":"A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma","status":"COMPLETED","sponsor":"CStone Pharmaceuticals","startDate":"2018-05-22","conditions":"Hodgkin Lymphoma","enrollment":82},{"nctId":"NCT03312842","phase":"PHASE1","title":"A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors","status":"COMPLETED","sponsor":"CStone Pharmaceuticals","startDate":"2017-10-19","conditions":"Advanced Cancer","enrollment":259}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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":"CS1001 monoclonal antibody","genericName":"CS1001 monoclonal antibody","companyName":"CStone Pharmaceuticals","companyId":"cstone-pharmaceuticals","modality":"Biologic","firstApprovalDate":"","aiSummary":"CS1001 is a monoclonal antibody that blocks PD-L1, preventing its interaction with PD-1 and PD-L2 receptors to enhance anti-tumor immune responses. Used for Non-small cell lung cancer, Gastric cancer, Esophageal cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}