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Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

RECRUITINGPhase 1Sponsored by Vincerx Pharma, Inc.
Actively Recruiting
PhasePhase 1
SponsorVincerx Pharma, Inc.
Started2023-09-13
Est. completion2025-05-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations5 sites
View on ClinicalTrials.gov →

NCT06034275

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+ hematologic malignancies

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

Acute Myeloid LeukemiaB-cell Acute Lymphoblastic LeukemiaCancerHigh-risk Myelodysplastic Syndrome

Locations5 sites

Alabama

1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Research Site

Ohio

1 site
University of Cincinnati
Cincinnati, Ohio, 45219
Research Site

Tennessee

1 site
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
Research Site

Texas

1 site
MD Anderson Cancer Center
Houston, Texas, 77030
Research Site

Washington

1 site
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Research Site

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