Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome
Conditions
Keywords
ADC, Hematologic Malignancies, Leukemia, CD123, B-ALL, AML, MDS, Relapsed/ Refractory, Hematologic Diseases, Bone Marrow Diseases
Brief summary
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
Detailed description
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.
Interventions
DRUGVIP943 (QW)
VIP943 will be administered by IV Infusion weekly
DRUGVIP943 (BIW)
VIP943 will be administered by IV Infusion bi-weekly
Sponsors
Vincerx Pharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sequential Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactVincerx Clinical Trials Contact
Outcome results
None listed