Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
NCT ID: NCT06034275
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2023-09-13
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation of VIP943 (QW)
Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration weekly (QW).
VIP943 (QW)
VIP943 will be administered by IV Infusion weekly
Dose Escalation of VIP943 (BIW)
Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration twice weekly (BIW).
VIP943 (BIW)
VIP943 will be administered by IV Infusion bi-weekly
Interventions
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VIP943 (QW)
VIP943 will be administered by IV Infusion weekly
VIP943 (BIW)
VIP943 will be administered by IV Infusion bi-weekly
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Vincerx Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Vincerx Study Director
Role: STUDY_DIRECTOR
Vincerx Pharma, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Cincinnati
Cincinnati, Ohio, United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Research Site
Role: primary
Other Identifiers
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VNC-943-101
Identifier Type: -
Identifier Source: org_study_id
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