RECRUITING

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

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Conditions

Acute Myeloid LeukemiaB-cell Acute Lymphoblastic LeukemiaHigh-risk Myelodysplastic SyndromeADCHematologic MalignanciesLeukemiaCD123B-ALLAMLMDSRelapsed/ RefractoryHematologic DiseasesBone Marrow Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official 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

Quick Facts

Study Start:2023-09-13
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06034275

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed AML, B-ALL or MDS. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
  2. * 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.
  3. * Evidence of CD123 expression from a local laboratory.
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  1. * Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  2. * 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.

Contacts and Locations

Study Contact

Vincerx Clinical Trials Contact
CONTACT
16508006676
clinicaltrials@vincerx.com

Principal Investigator

Vincerx Study Director
STUDY_DIRECTOR
Vincerx Pharma, Inc.

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Vincerx Pharma, Inc.

  • Vincerx Study Director, STUDY_DIRECTOR, Vincerx Pharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-13
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-09-13
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • ADC
  • Hematologic Malignancies
  • Leukemia
  • CD123
  • B-ALL
  • AML
  • MDS
  • Relapsed/ Refractory
  • Hematologic Diseases
  • Bone Marrow Diseases

Additional Relevant MeSH Terms

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