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 VIP943

What's the purpose of this trial?

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

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Phase 1

Enrollment: 36 patients (estimated)

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Trial Locations

All Trial Locations

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Alabama

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

Birmingham, AL

Open and Accepting

Ohio

University of Cincinnati College of Medicine George L. Strike Bone Marrow Transplant Program

Cincinnati, OH

Open and Accepting

Tennessee

Sarah Cannon Research Institute at Tennessee Oncology TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
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