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NCT06034275PHASE1Recruiting

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Vincerx Pharma, Inc.

Start Date

9/13/2023

Completion Date

12/31/2025

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

VIP943 (QW)

DRUG

VIP943 (BIW)

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Conditions

Acute Myeloid LeukemiaB-cell Acute Lymphoblastic LeukemiaHigh-risk Myelodysplastic Syndrome

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

TriStar Bone Marrow Transplant

Nashville, Tennessee 37203

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States