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Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Primary Purpose

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

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VIP943
Sponsored by
Vincerx Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring ADC, Hematologic Malignancies, Leukemia, CD123, B-ALL, AML, MDS, Relapsed/ Refractory, Hematologic Diseases, Bone Marrow Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • TriStar Bone Marrow TransplantRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation of VIP943

Arm Description

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).

Outcomes

Primary Outcome Measures

Incidence of DLT (Dose limit toxicity) of VIP943

Secondary Outcome Measures

Response rate to VIP943 as assessed by investigators using disease-specific response criteria
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943

Full Information

First Posted
September 5, 2023
Last Updated
September 15, 2023
Sponsor
Vincerx Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06034275
Brief Title
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vincerx Pharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation of VIP943
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
VIP943
Intervention Description
VIP943 will be administered by IV Infusion weekly
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincerx Clinical Trials Contact
Phone
16508006676
Email
clinicaltrials@vincerx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincerx Study Director
Organizational Affiliation
Vincerx Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
TriStar Bone Marrow Transplant
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Site

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

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