{"id":"fap-il2v","safety":{"commonSideEffects":[{"rate":null,"effect":"Cytokine-related toxicity (fever, chills, fatigue)"},{"rate":null,"effect":"Immune-related adverse events"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This drug combines a FAP-targeting moiety with IL-2 to selectively deliver immune activation to the tumor microenvironment. By engaging FAP+ cancer-associated fibroblasts and simultaneously providing IL-2 signaling, it aims to reprogram the immunosuppressive tumor stroma and enhance T-cell infiltration and activation. This dual mechanism targets both the cellular and immunological components of the tumor microenvironment.","oneSentence":"FAP IL2V is a bispecific immunotherapy that targets fibroblast activation protein (FAP) on cancer-associated fibroblasts while delivering interleukin-2 (IL-2) to activate anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:16.136Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Solid tumors (in clinical development)"},{"name":"Cancer-associated fibroblast-rich tumors"}]},"trialDetails":[{"nctId":"NCT03768063","phase":"PHASE3","title":"A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2019-02-28","conditions":"Cancer","enrollment":1000},{"nctId":"NCT03875079","phase":"PHASE1","title":"A Study to Evaluate Safety and Therapeutic Activity of RO6874281 in Combination with Pembrolizumab, in Participants with Advanced or Metastatic Melanoma","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2019-06-24","conditions":"Metastatic Melanoma","enrollment":83},{"nctId":"NCT03386721","phase":"PHASE2","title":"Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors","status":"TERMINATED","sponsor":"Hoffmann-La Roche","startDate":"2018-02-19","conditions":"Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers","enrollment":256},{"nctId":"NCT02627274","phase":"PHASE1","title":"A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2015-12-07","conditions":"Solid Tumor, Breast Cancer, Cancer of Head and Neck","enrollment":134}],"_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":["simlukafusp alfa"],"phase":"phase_3","status":"active","brandName":"FAP IL2V","genericName":"FAP IL2V","companyName":"Hoffmann-La Roche","companyId":"hoffmann-la-roche","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FAP IL2V is a bispecific immunotherapy that targets fibroblast activation protein (FAP) on cancer-associated fibroblasts while delivering interleukin-2 (IL-2) to activate anti-tumor immune responses. Used for Solid tumors (in clinical development), Cancer-associated fibroblast-rich tumors.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}