Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

• ClinicalTrials.gov Identifier: NCT06034275
• Recruitment Status: Recruiting
• First Posted: September 13, 2023
• Last Update Posted: January 12, 2024
• Sponsor: Vincerx Pharma, Inc.
• Information provided by (Responsible Party): Vincerx Pharma, Inc.

Tracking Information

• First Submitted Date: September 5, 2023
• First Posted Date: September 13, 2023
• Last Update Posted Date: January 12, 2024
• Actual Study Start Date: September 13, 2023
• Estimated Primary Completion Date: May 30, 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 5, 2023): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 5, 2023)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:

Sequential Assignment

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

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

Intervention

Drug: VIP943

VIP943 will be administered by IV Infusion weekly

Study Arms

Experimental: Dose Escalation of VIP943

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: Drug: VIP943

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 5, 2023): 36
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: May 30, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Vincerx Clinical Trials Contact; 16508006676; clinicaltrials@vincerx.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06034275
• Other Study ID Numbers: VNC-943-101
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Vincerx Pharma, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Vincerx Pharma, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Vincerx Study Director; Vincerx Pharma, Inc.

• PRS Account: Vincerx Pharma, Inc.
• Verification Date: January 2024