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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


Outcome Timeframe Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

NCTID NCT06034275

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2023-09-13

Completion Date 2025-05-30

Enrollment Target 36

Interventions

DRUG VIP943

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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