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Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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
What is being tested
- VIP943 (QW) (drug)
- VIP943 (BIW) (drug)
Sponsor: Vincerx Pharma, Inc. · Participants: 36 · Started: Sep 13, 2023
Contact the study team
- Vincerx Clinical Trials Contact · Phone: 16508006676
Official record on ClinicalTrials.gov — NCT06034275
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.