Clinical trial NCT06034275: 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
Overall status: RECRUITING
Phase: PHASE1
Conditions: 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
Lead sponsor: Vincerx Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of DLT (Dose limit toxicity) of VIP943
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Secondary outcomes:
measure: Response rate to VIP943 as assessed by investigators using disease-specific response criteria
timeFrame: 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)
measure: Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
measure: Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Nashville
country: United States
facility: TriStar Bone Marrow Transplant
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
Study officials:
affiliation: Vincerx Pharma, Inc.
name: Vincerx Study Director
role: STUDY_DIRECTOR
References: