Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia; B-cell Acute Lymphoblastic Leukemia; High-risk Myelodysplastic Syndrome
• Interventions: Drug: VIP943 (QW); Drug: VIP943 (BIW)

• Registration Number: NCT06034275
• Lead Sponsor: Vincerx Pharma, Inc.

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.

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Study Start: 2023-09-13
• Study First Posted: 2023-09-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-05-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation of VIP943 (QW)	VIP943 (QW)	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).
Dose Escalation of VIP943 (BIW)	VIP943 (BIW)	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

TriStar Bone Marrow Transplant; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States