Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Vincerx Pharma

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: VIP943 (BIW); Drug: VIP943 (QW)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06034275

VNC-943-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Dose Escalation of VIP943 (QW)

Experimental group

Description:

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).

Treatment:

Drug: VIP943 (QW)

Dose Escalation of VIP943 (BIW)

Experimental group

Description:

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 twice weekly (BIW).

Treatment:

Drug: VIP943 (BIW)