{"id":"bcd-100","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Immune-related pneumonitis"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Rash"},{"rate":null,"effect":"Immune-related hepatitis"}]},"_chembl":{"chemblId":"CHEMBL320633","moleculeType":"Small molecule","molecularWeight":"484.51"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCD-100 targets programmed death ligand 1 (PD-L1) expressed on tumor cells and immune cells, preventing the suppression of T-cell mediated immunity. By blocking the PD-L1/PD-1 axis, the drug releases the brakes on the immune system, allowing T cells to recognize and attack cancer cells more effectively. This mechanism is similar to other checkpoint inhibitors in the immuno-oncology space.","oneSentence":"BCD-100 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:40.837Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Other solid tumors (under investigation)"}]},"trialDetails":[{"nctId":"NCT05732805","phase":"PHASE3","title":"A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Biocad","startDate":"2022-08-02","conditions":"Melanoma, Melanoma (Skin), Melanoma Stage III","enrollment":270},{"nctId":"NCT03913923","phase":"PHASE2","title":"Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma","status":"UNKNOWN","sponsor":"Biocad","startDate":"2019-07-01","conditions":"Melanoma, Melanoma Metastatic","enrollment":117},{"nctId":"NCT03288870","phase":"PHASE2, PHASE3","title":"Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)","status":"UNKNOWN","sponsor":"Biocad","startDate":"2017-09-19","conditions":"Non Small Cell Lung Cancer Stage IIIB, Non-Small Cell Carcinoma of Lung, TNM Stage 4","enrollment":218},{"nctId":"NCT03269565","phase":"PHASE2","title":"International Trial of the Efficacy and Safety of BCD-100 in Patients With Melanoma","status":"UNKNOWN","sponsor":"Biocad","startDate":"2017-08-31","conditions":"Melanoma","enrollment":126},{"nctId":"NCT03912415","phase":"PHASE3","title":"Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer (FERMATA)","status":"UNKNOWN","sponsor":"Biocad","startDate":"2019-10-01","conditions":"Cervical Cancer","enrollment":316},{"nctId":"NCT03912389","phase":"PHASE3","title":"Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy as First Line Treatment in Patients With Advanced Non-Squamous NSCLC","status":"UNKNOWN","sponsor":"Biocad","startDate":"2019-06-01","conditions":"Non-Squamous Non-Small Cell Neoplasm of Lung","enrollment":292},{"nctId":"NCT03912402","phase":"PHASE2","title":"Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy and Bevacizumab in Patients With Recurrent, Persistent or Metastatic Cervical Cancer (CAESURA)","status":"UNKNOWN","sponsor":"Biocad","startDate":"2018-12-25","conditions":"Cervical Cancer, Cervical Cancer Metastatic, Cervical Cancer Recurrent","enrollment":49},{"nctId":"NCT03050047","phase":"PHASE1","title":"A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of BCD-100 in Patients With Advanced Solid Tumors","status":"UNKNOWN","sponsor":"Biocad","startDate":"2016-08-30","conditions":"Melanoma, Lung Cancer, Renal Cell Carcinoma","enrollment":15}],"_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":["prolgolimab","Forteca"],"phase":"phase_3","status":"active","brandName":"BCD-100","genericName":"BCD-100","companyName":"Biocad","companyId":"biocad","modality":"Biologic","firstApprovalDate":"","aiSummary":"BCD-100 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses. Used for Non-small cell lung cancer, Other solid tumors (under investigation).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}