|Trial||Title||Study Record Detail||Phase||Sponsor/Colaborator|
|A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4||NCT01409135||Phase I||Astellas Pharma Inc, Agensys, Inc./Seattle Genetics, Inc.|
|A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4||NCT02091999||Phase I||Astellas Pharma Inc, Agensys, Inc./Seattle Genetics, Inc.|
ASG-22ME (formerly AGS-22M6E); ASG-22CE, AGS-22CE, AGS-22M, AGS-22ME, ASG-22ME, unconjugated : AGS-22C3 or AGSM6)
ASG-22ME (formerly AGS-22M6E) and ASG-22CE are fully human monoclonal antibody conjugated to a cytotoxic agent monomethyl auristatin E (MMAE) targeting nectin-4 (Agensys code name AGS-22). The main difference between ASG-22ME and ASG-22CE is the change in cell line for antibody production. ASG-22ME and ASG-22CE are both administered at mg/kg doses based on the subjects weight at baseline and doses will not change unless the subjects weight changes by ≥ 10% from their baseline weight or the investigational product Dosage Assessment criteria is met.
Last Editorial Review: July 29, 2016
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