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Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

NCT06034275 · Vincerx Pharma, Inc.
In plain English

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Official title
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
About this study
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 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.
Study design
Enrollment target: 36 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-09-13
Estimated completion: 2025-12-31
Last updated: 2024-11-15
Interventions
Drug: VIP943 (QW)Drug: VIP943 (BIW)
Primary outcomes
  • Incidence of DLT (Dose limit toxicity) of VIP943 (Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days)
Sponsor
Vincerx Pharma, Inc. · industry
Contacts & investigators
ContactVincerx Clinical Trials Contact · contact · clinicaltrials@vincerx.com · 16508006676
InvestigatorVincerx Study Director · study_director, Vincerx Pharma, Inc.
All locations (5)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
University of CincinnatiRecruiting
Cincinnati, Ohio, United States
TriStar Bone Marrow TransplantRecruiting
Nashville, Tennessee, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies · TrialPath