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About
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.
Full description
IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days.
Enrollment
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Inclusion criteria
Disease Characteristics:
a. Confirmation of CD123 positivity by flow cytometry or IHC. Participants who received prior CD123-targeting agents will be allowed as long as the blasts still have detectable CD123 expression.
Expansion inclusion:
Note: Participants in Cohort 6 may have received local therapy (radiotherapy, surgical excision, photodynamic therapy). Eligible participants must have a recurrence or progression in the field of local therapy OR disease outside the field of local therapy.
Exclusion criteria
Note: the exception that participants who have received a checkpoint inhibitor must not have received that therapy within 28 days prior to drug administration on this study.
Primary purpose
Allocation
Interventional model
Masking
179 participants in 1 patient group
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Central trial contact
ImmunoGen Clinical Trials
Data sourced from clinicaltrials.gov
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