{"id":"l19il2-l19tnf","safety":{"commonSideEffects":[{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hypotension"},{"rate":null,"effect":"Elevated liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL2109608","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"L19 is a human recombinant antibody that selectively binds to the extra domain B (EDB) of fibronectin, which is highly expressed in tumor vasculature but absent in normal adult tissues. IL2 (interleukin-2) and TNF (tumor necrosis factor) are fused to this antibody, allowing targeted delivery of these immunostimulatory cytokines directly to tumors. This approach combines vascular targeting with localized immune activation to enhance anti-tumor immunity while minimizing systemic toxicity.","oneSentence":"L19IL2 + L19TNF is a bispecific antibody-cytokine fusion combination that targets tumor vasculature via the L19 antibody while delivering IL-2 and TNF directly to the tumor microenvironment.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:02.709Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic melanoma"},{"name":"Metastatic renal cell carcinoma"}]},"trialDetails":[{"nctId":"NCT07227350","phase":"PHASE2","title":"L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)","status":"NOT_YET_RECRUITING","sponsor":"Philogen S.p.A.","startDate":"2026-02","conditions":"Locally Advanced Basal Cell Carcinoma","enrollment":180},{"nctId":"NCT07228442","phase":"PHASE2","title":"L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"Philogen S.p.A.","startDate":"2026-02","conditions":"Locally Advanced Cutaneous Squamous Cell Carcinoma","enrollment":92},{"nctId":"NCT07227870","phase":"PHASE2","title":"L19IL2/TNF in Patients With Basal Cell Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"Philogen S.p.A.","startDate":"2026-02","conditions":"Locally Advanced Basal Cell Carcinoma","enrollment":92},{"nctId":"NCT03567889","phase":"PHASE3","title":"Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients","status":"RECRUITING","sponsor":"Philogen S.p.A.","startDate":"2018-09-20","conditions":"Melanoma Stage IIIB, Melanoma Stage IIIC, Melanoma Stage IIID","enrollment":186},{"nctId":"NCT07046728","phase":"","title":"Efficay and Safety of DAROMUN on Patient Treated by Intralesionnal Injection: DAROMEL","status":"NOT_YET_RECRUITING","sponsor":"Centre Hospitalier Universitaire de Nice","startDate":"2025-07-01","conditions":"Injections Intralesional","enrollment":70},{"nctId":"NCT06284590","phase":"PHASE2","title":"Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients","status":"RECRUITING","sponsor":"Philogen S.p.A.","startDate":"2024-07-12","conditions":"Melanoma Stage III, Melanoma Stage IV","enrollment":162},{"nctId":"NCT02938299","phase":"PHASE3","title":"Neoadjuvant L19IL2/L19TNF- Pivotal Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Philogen S.p.A.","startDate":"2016-07-01","conditions":"Malignant Melanoma","enrollment":214},{"nctId":"NCT04362722","phase":"PHASE2","title":"Intratumoral Administration of Daromun in Non-melanoma Skin Cancer Patients","status":"UNKNOWN","sponsor":"Philogen S.p.A.","startDate":"2020-09-02","conditions":"Carcinoma, Basal Cell, Carcinoma, Cutaneous Squamous Cell","enrollment":40},{"nctId":"NCT05329792","phase":"PHASE2","title":"L19IL2/L19TNF in Skin Cancer Patients","status":"UNKNOWN","sponsor":"Philogen S.p.A.","startDate":"2023-03-09","conditions":"BCC - Basal Cell Carcinoma, SCC - Squamous Cell Carcinoma, Merkel Cell Carcinoma","enrollment":70},{"nctId":"NCT02076633","phase":"PHASE2","title":"Intratumoral Administration of L19IL2/L19TNF","status":"COMPLETED","sponsor":"Philogen S.p.A.","startDate":"2012-12","conditions":"Malignant Melanoma, Skin","enrollment":21}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"L19IL2 + L19TNF","genericName":"L19IL2 + L19TNF","companyName":"Philogen S.p.A.","companyId":"philogen-s-p-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"L19IL2 + L19TNF is a bispecific antibody-cytokine fusion combination that targets tumor vasculature via the L19 antibody while delivering IL-2 and TNF directly to the tumor microenvironment. Used for Metastatic melanoma, Metastatic renal cell carcinoma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}