An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP943 Monotherapy in Subjects With Advanced CD123+ Hematologic Malignancies
Summary
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
Detailed description
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.
Arms & interventions
- DrugVIP943 (QW)
VIP943 will be administered by IV Infusion weekly
- DrugVIP943 (BIW)
VIP943 will be administered by IV Infusion bi-weekly
Outcome measures
Primary
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
Secondary
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
Eligibility criteria
Study locations (5)
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Cincinnati
Cincinnati, Ohio, 45219
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
MD Anderson Cancer Center
Houston, Texas, 77030
Fred Hutchinson Cancer Center
Seattle, Washington, 98109