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Study of VIP943 for Advanced CD123+ Blood Cancers

This study is testing a drug called VIP943 in people with advanced acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), or high-risk myelodysplastic syndrome (MDS). These are types of blood cancers where your body makes abnormal blood cells. You may be able to join if your cancer has a specific marker called CD123, and if standard treatments haven't worked or aren't an option for you. The main goal is to find the safest dose of VIP943 and see how well people tolerate it. The study plans to enroll 36 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to determine the maximum tolerated dose or optimal biologic dose of VIP943.
What's involved
VIP943 will be given weekly or bi-weekly through an IV infusion. The study will assess safety from the start of treatment through the beginning of the second cycle, with each cycle lasting up to 28 days.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured from Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days.

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NCT06034275

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Vincerx Pharma, Inc.
~36 participants
Updated 2024-11-15 on ClinicalTrials.gov
What's tested:VIP943 (QW)VIP943 (BIW)

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of DLT (Dose limit toxicity) of VIP943
Measured over Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

Conditions

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

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Where it's being run

5 sites across 5 states
Alabama1
Ohio1
Tennessee1
Texas1
Washington1

Study leadership

  • Vincerx Study Director · STUDY_DIRECTOR · Vincerx Pharma, Inc.

Who to contact

Vincerx Clinical Trials Contact
[email protected]
16508006676
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence of DLT (Dose limit toxicity) of VIP943Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days