Recruiting
Phase 1

VIP943

Sponsor:

Vincerx Pharma, Inc.

Code:

NCT06034275

Conditions

Acute Myeloid Leukemia

B-cell Acute Lymphoblastic Leukemia

High-risk Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VIP943 (QW)

VIP943 (BIW)

Study Details

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

Study ID

NCT06034275

Start date

Sep 13, 2023

Status verified date

Nov, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

May 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation of 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).

experimental: Dose Escalation of 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).

Interventions

VIP943 (QW)

VIP943 will be administered by IV Infusion weekly

VIP943 (BIW)

VIP943 will be administered by IV Infusion bi-weekly

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Vincerx Clinical Trials Contact

16508006676clinicaltrials@vincerx.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

TriStar Bone Marrow Transplant

Recruiting

Nashville, Tennessee, United States, 37203

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

Vincerx Pharma, Inc.

Last update posted

Nov 15, 2024

Last verified

Nov, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vincerx Pharma, Inc. on 2024-11-15.