Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies
Relapsed or refractory AML, MDS, or B-ALL subjects who are CD123 positive. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
VIP943 will be administered by IV Infusion weekly
VIP943 will be administered by IV Infusion bi-weekly
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUniversity of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGTriStar Bone Marrow Transplant
Nashville, Tennessee, United States
Incidence of DLT (Dose limit toxicity) of VIP943
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Response rate to VIP943 as assessed by investigators using disease-specific response criteria
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
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MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGFred Hutchinson Cancer Center
Seattle, Washington, United States
RECRUITING