Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Recruiting now · Phase 1

Conditions studied: Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome

In brief

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

Key facts

Study ID

NCT06034275

Run by

Vincerx Pharma, Inc.

People needed

36

Starts

2023-09-13

Expected to finish

2025-12-31

Last updated by the study team

2024-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• TriStar Bone Marrow Transplant — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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