Testing VIP943 for advanced blood cancers
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
Run by Vincerx Pharma, Inc. · NCT06034275 · Data updated 2026-11-12
This study is testing a new drug called VIP943 to see if it can safely help people with advanced blood cancers like leukemia and myelodysplastic syndrome who have run out of other treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Vincerx Pharma, Inc. Industry-sponsored |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Status | Recruiting |
| Started | September 13, 2023 |
| Main results expected | May 30, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | November 15, 2024 |
| Trial ID | NCT06034275 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with relapsed or refractory AML, B-ALL, or MDS who are CD123 positive and have exhausted standard therapies.
✕Probably not a fit
Patients with known central nervous system metastases or significant cardiac disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and tolerability of VIP943 in patients with advanced CD123+ hematologic malignancies, including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), and high-risk myelodysplastic syndrome (MDS). It aims to determine the maximum tolerated dose (MTD) or the minimum optimal biologic dose (OBD) through a dose escalation approach. Participants must have exhausted all standard therapies or be ineligible for available treatments, and the study will assess drug activity based on the presence of specific blood or bone marrow blasts.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced blood cancers who have limited treatment choices.
How similar studies have gone: Other studies targeting CD123 in hematologic malignancies have shown promise, indicating potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting -
University of Cincinnati
Cincinnati, Ohio, United States Recruiting -
TriStar Bone Marrow Transplant
Nashville, Tennessee, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
Fred Hutchinson Cancer Center
Seattle, Washington, United States Recruiting
Study contacts
- Study coordinator: Vincerx Clinical Trials Contact
- Email: clinicaltrials@vincerx.com
- Phone: 16508006676
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.