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Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

ConditionsAcute Myeloid LeukemiaB-cell Acute Lymphoblastic LeukemiaHigh-risk Myelodysplastic Syndrome
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVincerx Pharma, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VIP943 (QW)

    Drug

    VIP943 will be administered by IV Infusion weekly

  • VIP943 (BIW)

    Drug

    VIP943 will be administered by IV Infusion bi-weekly

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Dose Escalation of VIP943 (QW)Experimental treatment 1 intervention
Group B: Dose Escalation of VIP943 (BIW)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of DLT (Dose limit toxicity) of VIP943

Time frame
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

Secondary outcomes

1

Response rate to VIP943 as assessed by investigators using disease-specific response criteria

Time frame
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)
2

Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943

Time frame
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
3

Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943

Time frame
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vincerx Pharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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