{"id":"lbl-007","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hemorrhage"},{"rate":null,"effect":"Atrial fibrillation"}]},"_chembl":{"chemblId":"CHEMBL5974311","moleculeType":null,"molecularWeight":"379.49"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BTK is a critical signaling molecule in B-cell receptor and toll-like receptor pathways. By inhibiting BTK, LBL-007 reduces proliferation and survival of malignant B cells and suppresses the tumor microenvironment. This mechanism has demonstrated efficacy in chronic lymphocytic leukemia and other B-cell lymphomas.","oneSentence":"LBL-007 is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK signaling to suppress B-cell and myeloid cell activation in hematologic malignancies.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:27.202Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic lymphocytic leukemia (CLL)"},{"name":"Small lymphocytic lymphoma (SLL)"}]},"trialDetails":[{"nctId":"NCT04164199","phase":"PHASE3","title":"Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies","status":"ACTIVE_NOT_RECRUITING","sponsor":"BeOne Medicines","startDate":"2019-12-19","conditions":"Advanced Malignancies","enrollment":404},{"nctId":"NCT05635708","phase":"PHASE2","title":"A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"BeiGene","startDate":"2023-03-07","conditions":"Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer","enrollment":400},{"nctId":"NCT05577702","phase":"PHASE2","title":"Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"BeiGene","startDate":"2023-03-08","conditions":"Non Small Cell Lung Cancer","enrollment":121},{"nctId":"NCT07099430","phase":"PHASE1, PHASE2","title":"A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma","status":"RECRUITING","sponsor":"Nanjing Leads Biolabs Co.,Ltd","startDate":"2025-09-05","conditions":"Advanced Melanoma","enrollment":200},{"nctId":"NCT05516914","phase":"PHASE1, PHASE2","title":"A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors","status":"RECRUITING","sponsor":"Nanjing Leads Biolabs Co.,Ltd","startDate":"2022-09-01","conditions":"Malignant Tumors","enrollment":490},{"nctId":"NCT06010303","phase":"PHASE2","title":"A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"BeiGene","startDate":"2023-11-08","conditions":"Esophageal Cancer, Esophageal Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma by AJCC V8 Stage","enrollment":118},{"nctId":"NCT05909904","phase":"PHASE2","title":"A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"BeiGene","startDate":"2023-07-21","conditions":"Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer","enrollment":160},{"nctId":"NCT05609370","phase":"PHASE1, PHASE2","title":"A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"BeiGene","startDate":"2023-01-29","conditions":"Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer","enrollment":113},{"nctId":"NCT03744468","phase":"PHASE1, PHASE2","title":"Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors","status":"COMPLETED","sponsor":"BeiGene","startDate":"2018-11-13","conditions":"Locally Advanced or Metastatic Solid Tumors for Phase 1,Dose Escalation and Phase 2 Safety Lead-in, HNSCC, NSCLC and RCC Participants for Phase 2","enrollment":114},{"nctId":"NCT04640545","phase":"PHASE1","title":"A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma","status":"COMPLETED","sponsor":"Nanjing Leads Biolabs Co.,Ltd","startDate":"2020-05-12","conditions":"Advanced Melanoma","enrollment":79},{"nctId":"NCT05102006","phase":"PHASE1, PHASE2","title":"A Phase Ib/II Clinical Study of LBL-007 in Combination With Toripalimab in Treatment of Advanced Malignant Tumors","status":"COMPLETED","sponsor":"Nanjing Leads Biolabs Co.,Ltd","startDate":"2021-11-30","conditions":"Advanced Malignant Tumors","enrollment":80}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"MYELOSUPPRESSION"}],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Alcestobart","LBL-007"],"phase":"phase_3","status":"active","brandName":"LBL-007","genericName":"LBL-007","companyName":"BeiGene","companyId":"beigene","modality":"Small molecule","firstApprovalDate":"","aiSummary":"LBL-007 is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK signaling to suppress B-cell and myeloid cell activation in hematologic malignancies. Used for Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}