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)
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