This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.
IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
179
CD123-targeted ADC
To assess the rate of composite CR in BPDCN patients
CR+clinical CR \[CRc\]
Time frame: 21-day cycle
To assess the duration of CR (DOCR) for patients with CR or CRc
Time frame: Up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: Up to 24 months
To assess the rate of CR+CRc+CRh
Time frame: Up to 24 months
To assess the duration of CR+CRc+CRh
Time frame: Up to 24 months
To assess ORR: CR+CRc+CRh+CRi+PR
Time frame: Up to 24 months
To assess the duration of overall response
Time frame: Up to 24 months
To assess OS
Time frame: Up to 24 months
To assess the percent of BPDCN patients able to bridge to stem cell transplant in the frontline and relapsed/refractory populations separately
Time frame: Up to 24 months
To characterize the PK of IMGN632, total antibody, and FGN849 (the active catabolite)
Time frame: Up to 24 months
To evaluate the potential immunogenicity of IMGN632
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Banner Health MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
UCLA
Los Angeles, California, United States
Stanford
Stanford, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Novant Health Cancer Institute Hematology
Charlotte, North Carolina, United States
...and 18 more locations
Time frame: Up to 24 months
To assess transfusion independence
Conversion rate to independence of red blood cell (RBC) and platelet transfusion relative to baseline
Time frame: Up to 24 months