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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
Description
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 malignanciesRelapsed 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.
Trial Eligibility
Inclusion Criteria: * Histologically confirmed AML, B-ALL or MDS. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies. * Evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow or blood myeloblasts (MDS) to allow for assessment of drug activity. * Evidence of CD123 expression from a local laboratory. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: * Known central nervous system (CNS) metastases and/or carcinomatous meningitis. * Clinically significant cardiac disease including congestive heart failure \> New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.
Study Info
Organization
Vincerx Pharma, Inc.
Primary Outcome
Incidence of DLT (Dose limit toxicity) of VIP943
Interventions
Locations Recruiting
University of Alabama at Birmingham
United States, Alabama, Birmingham
University of Cincinnati
United States, Ohio, Cincinnati
TriStar Bone Marrow Transplant
United States, Tennessee, Nashville
MD Anderson Cancer Center
United States, Texas, Houston
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