{"id":"abituzumab","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT02745145","NCT00848510","NCT03688230","NCT01360840","NCT00958477","NCT01008475"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2010","type":"neutral","milestone":"Phase 1 Initiated","description":"A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Dos — Prostate Cancer"},{"date":"2013","type":"neutral","milestone":"Phase 2 Initiated","description":"EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostat — Prostate Cancer Metastatic"}],"aiSummary":"Abituzumab is an agent being studied in various cancers. Clinical trials are evaluating its use in colorectal, ovarian, and prostate cancers with liver metastases. It is being investigated in combination with other therapies like cetuximab and FOLFIRI.","brandName":"ABITUZUMAB","companyId":"unknown","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Monoclonal antibody","drugClass":"","explanation":"Abituzumab is being evaluated for its potential to treat cancers that have spread to the liver. Clinical trials are underway to determine how well it works in different types of cancer. Researchers are also looking at combining it with existing treatments to see if it can improve outcomes.","oneSentence":"Abituzumab is being studied as a treatment for different cancers, including those that have spread to the liver.","technicalDetail":"Abituzumab is being studied in colorectal and ovarian cancer patients with liver metastases (n=41). It is also being studied in combination with cetuximab and FOLFIRI in metastatic colorectal cancer (n=0), and in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (n=180)."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"ABITUZUMAB","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02745145","phase":"Phase 2","title":"A Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitia","status":"TERMINATED","sponsor":"EMD Serono Research & Development Institute, Inc.","isPivotal":false,"enrollment":24,"indication":"Systemic Sclerosis-associated Interstitial Lung Disease","completionDate":"2018-05-30"},{"nctId":"NCT00848510","phase":"Phase 1","title":"A Phase I, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, PD and PK of EMD 525797 Using DCE-MRI as a PK Measure of Response in Colorectal and Ovarian Cancer Patients With L","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","isPivotal":false,"enrollment":41,"indication":"Colorectal and Ovarian Cancer Patients With Liver Metastases","completionDate":"2013-11"},{"nctId":"NCT03688230","phase":"Phase 2","title":"AMELION: A Randomized, Double Blinded, Phase 2, Efficacy and Safety Study of Abituzumab (EMD 525797) in Combination With Cetuximab and FOLFIRI Versus Placebo in Combination With Cetuximab and FOLFIRI ","status":"WITHDRAWN","sponsor":"SFJ Pharmaceuticals X, LTD.","isPivotal":false,"enrollment":0,"indication":"Metastatic Colorectal Cancer","completionDate":"2021-08"},{"nctId":"NCT01360840","phase":"Phase 2","title":"A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prost","status":"COMPLETED","sponsor":"EMD Serono","isPivotal":false,"enrollment":180,"indication":"Prostate Cancer Metastatic","completionDate":"2014-07"},{"nctId":"NCT00958477","phase":"Phase 1","title":"Phase I, Open-label Study to Investigate Safety, Tolerability, PK, and PD of EMD 525797 After Single and Repeated Dosing at Different Dose Levels in Subjects With Hormone-resistant Prostate Cancer Wit","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","isPivotal":false,"enrollment":26,"indication":"Prostate Cancer, Bone Metastases","completionDate":"2011-03"},{"nctId":"NCT01008475","phase":"Phase 1","title":"An Open-label, Randomized, Controlled, Multicenter, Phase I/II Trial Investigating 2 EMD 525797 Doses in Combination With Cetuximab and Irinotecan Versus Cetuximab and Irinotecan Alone, as Second-line","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","isPivotal":false,"enrollment":232,"indication":"Metastatic Colorectal Cancer","completionDate":"2015-04"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Monoclonal antibody","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}