{"id":"fda018-adc","safety":{"commonSideEffects":[{"rate":null,"effect":"Peripheral neuropathy"},{"rate":null,"effect":"Cytopenias"},{"rate":null,"effect":"Nausea/vomiting"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As an ADC (antibody-drug conjugate), FDA018-ADC combines a monoclonal antibody with a potent cytotoxic drug linker. The antibody component binds to a tumor-associated antigen on cancer cells, enabling selective delivery of the toxic payload to malignant cells while sparing healthy tissue. This targeted approach aims to improve efficacy and reduce systemic toxicity compared to conventional chemotherapy.","oneSentence":"FDA018-ADC is an antibody-drug conjugate that delivers cytotoxic payload to target cells expressing specific tumor antigens.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:12:20.130Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Solid tumors (specific indication under investigation in Phase 3)"}]},"trialDetails":[{"nctId":"NCT05174637","phase":"PHASE1","title":"A Study of FDA018-ADC in Patients With Advanced Solid Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.","startDate":"2021-10-22","conditions":"Advanced/ Metastatic Solid Tumors","enrollment":78},{"nctId":"NCT06519370","phase":"PHASE3","title":"FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.","startDate":"2024-08-09","conditions":"Triple Negative Breast Cancer","enrollment":350}],"_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":["FDA018-Antibody-drug Conjugate","F0024"],"phase":"phase_3","status":"active","brandName":"FDA018-ADC","genericName":"FDA018-ADC","companyName":"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.","companyId":"shanghai-fudan-zhangjiang-bio-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FDA018-ADC is an antibody-drug conjugate that delivers cytotoxic payload to target cells expressing specific tumor antigens. Used for Solid tumors (specific indication under investigation in Phase 3).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}