Enfortumab Vedotin (ASG-22ME, formerly AGS-22M6E) Clinical Trials

TrialTitleStudy Record DetailPhaseSponsor/Colaborator
A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4NCT01409135Phase IAstellas 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-4NCT02091999Phase IAstellas 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.