Phase 1 Dose Escalation Study for VIP943 Subjects With Advanced CD123+ Hematologic Malignancies

Sponsor

Vincerx Pharma, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06034275

Collaborator

(none)

Enrollment

Arm

27.8

Anticipated Duration (Months)

Study Details

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

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

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Sequential AssignmentSequential 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

Anticipated Study Start Date :

Sep 8, 2023

Anticipated Primary Completion Date :

May 30, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation of VIP943 Investigating VIP943 in dose escalation cohorts in subjects with AML, MDS, and B-ALL with CD123 expression	Drug: VIP943 VIP943 will be administered by IV Infusion weekly

Arm

Intervention/Treatment

Experimental: Dose Escalation of VIP943

Investigating VIP943 in dose escalation cohorts in subjects with AML, MDS, and B-ALL with CD123 expression

Drug: VIP943

VIP943 will be administered by IV Infusion weekly

Outcome Measures

Primary Outcome Measures

Incidence of DLT (Dose limit toxicity) of VIP943 [Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days]

Secondary Outcome Measures

Response rate to VIP943 as assessed by investigators using disease-specific response criteria [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 [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 [Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.