Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Last updated: November 13, 2024
Sponsor: Vincerx Pharma, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Hematologic Neoplasms

Neoplasms

Myelodysplastic Syndromes (Mds)

Treatment

VIP943

VIP943 (QW)

VIP943 (BIW)

Clinical Study ID

NCT06034275
VNC-943-101
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed AML, B-ALL or MDS. Subjects must have exhausted allavailable standard therapies or be deemed ineligible for potential availabletherapies.

  • Evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow orblood 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

Exclusion Criteria:

  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis.

  • Clinically significant cardiac disease including congestive heart failure > New YorkHeart Association (NYHA) Class II), evidence for coronary artery disease (eg,unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6months or myocardial infarction within the past 6 months before first dose.

Study Design

Total Participants: 36
Treatment Group(s): 3
Primary Treatment: VIP943
Phase: 1
Study Start date:
September 13, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • TriStar Bone Marrow Transplant

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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