Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Intervention Model Description
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation of VIP943 		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
    VIP943 will be administered by IV Infusion weekly

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Research Site

More Details

Status
Recruiting
Sponsor
Vincerx Pharma, Inc.

Study Contact

Vincerx Clinical Trials Contact
16508006676
clinicaltrials@vincerx.com

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.