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 the Dose Escalation Phase, patients will be assigned to one of three schedules. The MTD for all schedules will be determined from the assessment of Dose Limiting Toxicities (DLTs). The Dose Expansion Phase will consist of one cohort based on patients response to prior therapy according to the MTD selected.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Comprehensive Cancer Center (UAB CCC)
Birmingham, Alabama, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Maximum Tolerated Dose (MTD) of IMGN779
Time frame: 28 days
Treatment emergent adverse events
Time frame: Up to 12 months
Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR])
Time frame: Up to 12 months
PK parameters: maximum plasma concentration (Cmax) of IMGN779
Time frame: up to 12 months
PK parameters: area under the time-concentration curve (AUC) of IMGN779
Time frame: Up to 12 months
PK parameters: terminal half-life (t½) of IMGN779
Time frame: Up to 12 months
Immunogenicity: Presence of Antibody-Drug Antibody (ADA)
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Knight Cancer Institute - OSHU
Portland, Oregon, United States
Baylor Scott & White University Medical Center
Dallas, Texas, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States