Acute Myeloid Leukemia Clinical Trial
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
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
Status | Recruiting |
Enrollment | 36 |
Est. completion date | December 31, 2025 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | TriStar Bone Marrow Transplant | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vincerx Pharma, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of DLT (Dose limit toxicity) of VIP943 | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days | ||
Secondary | Response rate to VIP943 as assessed by investigators using disease-specific response criteria | 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) | ||
Secondary | Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943 | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days | ||
Secondary | Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943 | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days |
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