Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome

Intervention / Treatment
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* Drug: VIP943


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation of VIP943<br>Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration weekly (QW). | Drug: VIP943<br>* VIP943 will be administered by IV Infusion weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADC, Hematologic Malignancies, Leukemia, CD123, B-ALL, AML, MDS, Relapsed/ Refractory, Hematologic Diseases, Bone Marrow Diseases