Status:
RECRUITING
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
Lead Sponsor:
Vincerx Pharma, Inc.
Conditions:
Acute Myeloid Leukemia
B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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+ h...
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
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06034275
Start Date
September 13 2023
End Date
December 31 2025
Last Update
November 15 2024
Active Locations (5)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Cincinnati
Cincinnati, Ohio, United States, 45219
3
TriStar Bone Marrow Transplant
Nashville, Tennessee, United States, 37203
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030