NCT06034275 Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
| NCT ID | NCT06034275 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vincerx Pharma, Inc. |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-09-13 |
| Primary Completion | 2025-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2023-09-13 with a primary completion date of 2025-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Vincerx Study Director
STUDY DIRECTOR
Vincerx Pharma, Inc.
Frequently Asked Questions
Who can join the NCT06034275 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06034275 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06034275 currently recruiting?
Yes, NCT06034275 is actively recruiting participants. Contact the research team at clinicaltrials@vincerx.com for enrollment information.
Where is the NCT06034275 trial being conducted?
This trial is being conducted at Birmingham, United States, Cincinnati, United States, Nashville, United States, Houston, United States and 1 additional location.
Who is sponsoring the NCT06034275 clinical trial?
NCT06034275 is sponsored by Vincerx Pharma, Inc.. The principal investigator is Vincerx Study Director at Vincerx Pharma, Inc.. The trial plans to enroll 36 participants.
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