Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

NCT06034275 | Recruiting Phase 1 FDA Drug

• 1 other identifier: VNC-943-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

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

Conditions

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

Keywords

ADC; Hematologic Malignancies; Leukemia; CD123; B-ALL; AML; MDS; Relapsed/ Refractory; Hematologic Diseases; Bone Marrow Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Dose Escalation of VIP943 (QW)

EXPERIMENTAL

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 (QW)

Dose Escalation of VIP943 (BIW)

EXPERIMENTAL

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).

Drug: VIP943 (BIW)

Interventions

VIP943 (QW) DRUG

VIP943 will be administered by IV Infusion weekly

Dose Escalation of VIP943 (QW)

VIP943 (BIW) DRUG

VIP943 will be administered by IV Infusion bi-weekly

Dose Escalation of VIP943 (BIW)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vincerx Pharma, Inc.: lead

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

TriStar Bone Marrow Transplant

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Burkitt Lymphoma; Hematologic Neoplasms; Leukemia; Hematologic Diseases; Bone Marrow Diseases

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

Study Officials

• Vincerx Study Director

  Vincerx Pharma, Inc.

  STUDY DIRECTOR

Central Study Contacts

Vincerx Clinical Trials Contact

CONTACT

16508006676; clinicaltrials@vincerx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: September 13, 2023
• Primary Completion: May 30, 2025
• Study Completion: December 31, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)