Testing VIP943 for advanced blood cancers
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
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 |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vincerx Pharma, Inc. Industry-sponsored |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Trial ID | NCT06034275 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with relapsed or refractory AML, B-ALL, or MDS who are CD123 positive and have exhausted standard therapies.
Not a fit: Patients with known central nervous system metastases or significant cardiac disease may not benefit from this study.
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 performed: Other studies targeting CD123 in hematologic malignancies have shown promise, indicating potential for success with this approach.
Eligibility criteria
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 this trial is running
Birmingham, Alabama and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.