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NCT Number: NCT06034275

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

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

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Key information

Conditions

Acute Myeloid Leukemia B-cell Acute Lymphoblastic Leukemia Bone Marrow Diseases Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Herpesviridae Infections High-risk Myelodysplastic Syndrome Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Tumor Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VIP943 (QW)

Drug

VIP943 will be administered by IV Infusion weekly

VIP943 (BIW)

Drug

VIP943 will be administered by IV Infusion bi-weekly

Primary outcomes

  1. Incidence of DLT (Dose limit toxicity) of VIP943

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

Secondary outcomes

  1. Response rate to VIP943 as assessed by investigators using disease-specific response criteria

    Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)

  2. Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

  3. Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Vincerx Clinical Trials Contact

CONTACT

[email protected]

16508006676

Sponsors and collaborators

Lead sponsor

Vincerx Pharma, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2023
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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