{"id":"bcd-178","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"}]},"_chembl":{"chemblId":"CHEMBL3663475","moleculeType":"Small molecule","molecularWeight":"404.47"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCD-178 is a fully human monoclonal antibody designed to target programmed death ligand 1 (PD-L1) on tumor cells and immune cells. By blocking the PD-L1/PD-1 axis, the drug prevents tumor cells from suppressing T-cell activity, thereby reinvigorating the immune system to recognize and eliminate cancer cells. This mechanism is similar to other checkpoint inhibitors in the immuno-oncology space.","oneSentence":"BCD-178 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":"2026-03-28T01:02:58.497Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Other solid tumors (under investigation)"}]},"trialDetails":[{"nctId":"NCT06136897","phase":"PHASE2","title":"Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2017-03-23","conditions":"Malignant Solid Neoplasm","enrollment":35},{"nctId":"NCT02465060","phase":"PHASE2","title":"Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2015-08-17","conditions":"Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma","enrollment":6452},{"nctId":"NCT07407920","phase":"PHASE2","title":"Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2025-10-09","conditions":"Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2-Positive Breast Carcinoma","enrollment":120},{"nctId":"NCT03199885","phase":"PHASE3","title":"Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2019-04-05","conditions":"Metastatic Breast Adenocarcinoma, Metastatic HER2-Positive Breast Carcinoma, Recurrent Breast Adenocarcinoma","enrollment":190},{"nctId":"NCT04108858","phase":"PHASE1, PHASE2","title":"Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2021-05-20","conditions":"Anatomic Stage IV Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma, Metastatic Breast Carcinoma","enrollment":2},{"nctId":"NCT02003209","phase":"PHASE3","title":"Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2014-02-18","conditions":"HER2-Positive Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Stage IB Breast Cancer AJCC v7","enrollment":315},{"nctId":"NCT05802225","phase":"PHASE3","title":"Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Biocad","startDate":"2023-01-30","conditions":"Breast Cancer","enrollment":398},{"nctId":"NCT05738993","phase":"PHASE1","title":"A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers","status":"UNKNOWN","sponsor":"Biocad","startDate":"2022-08-08","conditions":"Breast Cancer","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["pertuzumab"],"phase":"phase_3","status":"active","brandName":"BCD-178","genericName":"BCD-178","companyName":"Biocad","companyId":"biocad","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BCD-178 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":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}