Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06034275
• Other study ID #: VNC-943-101
• Status: Recruiting
• Phase: Phase 1
• Start date: September 13, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Vincerx Pharma, Inc.
• Contact: Vincerx Clinical Trials Contact
• Phone: 16508006676
• Email: clinicaltrials[@]vincerx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• B-cell Acute Lymphoblastic Leukemia
• Hematologic Neoplasms
• High-risk Myelodysplastic Syndrome
• Leukemia
• Myelodysplastic Syndromes
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• VIP943
VIP943 will be administered by IV Infusion weekly

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Cincinnati	Cincinnati	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	TriStar Bone Marrow Transplant	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vincerx Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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