A Phase 1, Multi-Center, Open-Label Study of IMGN779 Administered Intravenously in Adult Patients with Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia
Description: 
This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 positive disease. In addition, the safety, tolerability, PK, immunogenicity and anti-tumor activity of IMGN779 will be evaluated. This Phase 1 study is comprised of a dose escalation stage and a dose expansion stage to further characterize the IMGN779 safety profile and determine the RP2D. The dose escalation stage will follow a 3+3 cohort design, with each cohort enrolling three or four to six patients. Two dosing schedules will be evaluated in the dose escalation stage of the study:
Study Number: 

PH 280115

Phase: 
Early Phase
Principal Investigator: 
ClinicalTrials.Gov ID: 
NCT02674763

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.