Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Description

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

Conditions

Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome

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Study Overview

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Study Details

Study overview

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

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

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Condition
Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Cincinnati

University of Cincinnati, Cincinnati, Ohio, United States, 45219

Nashville

TriStar Bone Marrow Transplant, Nashville, Tennessee, United States, 37203

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Seattle

Fred Hutchinson Cancer Center, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vincerx Pharma, Inc.,

Vincerx Study Director, STUDY_DIRECTOR, Vincerx Pharma, Inc.

Study Record Dates

2025-12-31