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RecruitingInterventionalPhase 1

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

NCT ID: NCT06034275Sponsor: Vincerx Pharma, Inc.Last updated: 2024-11-15

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.

Arms & interventions

  • DrugVIP943 (QW)

    VIP943 will be administered by IV Infusion weekly

  • DrugVIP943 (BIW)

    VIP943 will be administered by IV Infusion bi-weekly

Outcome measures

Primary

  • 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

  • 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)

  • 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

  • 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

Sex: AllAge: 18 Years and olderHealthy 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 locations (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

Recruiting
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University of Cincinnati

Cincinnati, Ohio, 45219

Recruiting
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TriStar Bone Marrow Transplant

Nashville, Tennessee, 37203

Recruiting
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MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
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Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting
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Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies | Cancerify