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Trial record 1 of 1 for:    VIP943
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Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT06034275
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : January 12, 2024
Sponsor:
Information provided by (Responsible Party):
Vincerx Pharma, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia B-cell Acute Lymphoblastic Leukemia High-risk Myelodysplastic Syndrome Drug: VIP943 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 13, 2023
Estimated Primary Completion Date : May 30, 2025
Estimated Study Completion Date : December 31, 2025

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Response rate to VIP943 as assessed by investigators using disease-specific response criteria [ Time Frame: 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) ]
  2. Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days ]
  3. Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06034275


Contacts
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Contact: Vincerx Clinical Trials Contact 16508006676 clinicaltrials@vincerx.com

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Research Site         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Research Site         
United States, Tennessee
TriStar Bone Marrow Transplant Recruiting
Nashville, Tennessee, United States, 37203
Contact: Research Site         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Research Site         
Sponsors and Collaborators
Vincerx Pharma, Inc.
Investigators
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Study Director: Vincerx Study Director Vincerx Pharma, Inc.
More Information
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Responsible Party: Vincerx Pharma, Inc.
ClinicalTrials.gov Identifier: NCT06034275    
Other Study ID Numbers: VNC-943-101
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: January 12, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincerx Pharma, Inc.:
ADC
Hematologic Malignancies
Leukemia
CD123
B-ALL
 AML
MDS
Relapsed/ Refractory
Hematologic Diseases
Bone Marrow Diseases
Additional relevant MeSH terms:
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Leukemia
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Neoplasms
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Hematologic Diseases
 Bone Marrow Diseases
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site