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Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Study 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

NCT06034275•Vincerx Pharma, Inc.

View on ClinicalTrials.gov

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

Detailed Description

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (5)

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

Key Dates

Start Date

September 13, 2023

Primary Completion Date

May 30, 2025

Completion Date

December 31, 2025

Last Updated

November 15, 2024

Enrollment

ESTIMATED participants

Conditions

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

Interventions

VIP943 (QW)

DRUG

VIP943 (BIW)

DRUG

Contacts

Vincerx Clinical Trials Contact

CONTACT

16508006676 clinicaltrials@vincerx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Inclusion Criteria

Exclusion Criteria

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