{"id":"ak111","safety":{"commonSideEffects":[{"rate":null,"effect":"Cytokine release syndrome"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"T-cell activation-related toxicity"}]},"_chembl":{"chemblId":"CHEMBL5095302","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"AK111 functions as a T-cell engager by binding CD3 on cytotoxic T lymphocytes while also binding EGFR on cancer cells, bringing these cells into close proximity and activating T-cell killing of EGFR+ tumor cells. This bispecific approach leverages the patient's own immune system to target malignant cells expressing elevated EGFR levels, a common feature in many solid tumors.","oneSentence":"AK111 is a bispecific antibody that simultaneously engages CD3 on T cells and EGFR on tumor cells to redirect immune attack against EGFR-expressing cancers.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:42:29.091Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"EGFR-expressing solid tumors (in clinical development)"}]},"trialDetails":[{"nctId":"NCT06378697","phase":"PHASE3","title":"A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis","status":"COMPLETED","sponsor":"Akeso","startDate":"2023-11-22","conditions":"Ankylosing Spondylitis","enrollment":510},{"nctId":"NCT06947109","phase":"PHASE1","title":"A Clinical Study of AK139 in Healthy Subjects","status":"NOT_YET_RECRUITING","sponsor":"Akeso","startDate":"2025-05-06","conditions":"Healthy Subjects","enrollment":48},{"nctId":"NCT05504317","phase":"PHASE1","title":"A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis","status":"COMPLETED","sponsor":"Akeso","startDate":"2020-05-28","conditions":"Psoriasis","enrollment":48},{"nctId":"NCT05096364","phase":"PHASE2","title":"A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis","status":"COMPLETED","sponsor":"Akeso","startDate":"2021-04-28","conditions":"Psoriasis","enrollment":251},{"nctId":"NCT03622021","phase":"PHASE1","title":"A Study of AK111 in Healthy Subjects","status":"COMPLETED","sponsor":"Akesobio Australia Pty Ltd","startDate":"2018-08-14","conditions":"Psoriasis","enrollment":68},{"nctId":"NCT06066125","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis","status":"COMPLETED","sponsor":"Akeso","startDate":"2023-03-31","conditions":"Psoriasis, Skin Diseases","enrollment":351},{"nctId":"NCT06061471","phase":"PHASE2","title":"To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis","status":"COMPLETED","sponsor":"Akeso","startDate":"2023-09-22","conditions":"Psoriasis, Skin Diseases","enrollment":454},{"nctId":"NCT05467995","phase":"PHASE2","title":"A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis","status":"COMPLETED","sponsor":"Akeso","startDate":"2021-06-02","conditions":"Ankylosing Spondylitis","enrollment":125}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"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":"AK111","genericName":"AK111","companyName":"Akeso","companyId":"akeso","modality":"Biologic","firstApprovalDate":"","aiSummary":"AK111 is a bispecific antibody that simultaneously engages CD3 on T cells and EGFR on tumor cells to redirect immune attack against EGFR-expressing cancers. Used for EGFR-expressing solid tumors (in clinical development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}