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Monoclonal Antibodies
VIP943 for Blood Cancers
Phase 1
Recruiting
Research Sponsored by Vincerx Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of CD123 expression from a local laboratory.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Must not have
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.
Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing VIP943, a new drug, to find the safest and most effective dose for patients with advanced blood cancers who have no other treatment options. The drug works by targeting a protein on cancer cells to help kill them or stop their growth.
Who is the study for?
This trial is for people with advanced blood cancers like leukemia, who have a specific marker called CD123. They should be fairly active and able to care for themselves (ECOG 0-2) and must have tried all standard treatments or can't receive them. People with brain cancer spread or serious heart problems cannot join.
What is being tested?
The study is testing VIP943's safety and finding the highest dose patients can take without severe side effects in those with CD123+ hematologic malignancies. It starts with small doses that increase until they find the right balance between effectiveness and safety.
What are the potential side effects?
Specific side effects of VIP943 are not listed, but generally, such drugs may cause fatigue, nausea, fever, bleeding risks, allergic reactions during infusion into the vein, liver issues, or impact on bone marrow function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cells show CD123 presence.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My leukemia or myelodysplastic syndrome has not responded to standard treatments.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have serious heart problems like recent heart attacks or severe chest pain.
Select...
My cancer has spread to my brain or its coverings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation of VIP943Experimental Treatment1 Intervention
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).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Lymphoblastic Leukemia (ALL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by using cytotoxic drugs to kill rapidly dividing leukemia cells, aiming to reduce the leukemia cell population to undetectable levels.
Targeted therapies, such as tyrosine kinase inhibitors (e.g., imatinib, dasatinib), specifically inhibit proteins involved in the growth and survival of leukemia cells, such as the BCR-ABL protein in Philadelphia chromosome-positive ALL. Immunotherapies, including monoclonal antibodies and CAR-T cell therapy, harness the patient's immune system to recognize and destroy leukemia cells.
Treatments like VIP943, which target CD123, a marker on leukemia cells, represent a form of immunotherapy that aims to selectively eliminate malignant cells while sparing normal cells. These mechanisms are crucial for ALL patients as they offer more precise and effective ways to eradicate leukemia cells, reduce relapse rates, and improve overall survival outcomes.
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Who is running the clinical trial?
Vincerx Pharma, Inc.Lead Sponsor
3 Previous Clinical Trials
140 Total Patients Enrolled
Vincerx Study DirectorStudy DirectorVincerx Pharma, Inc.
3 Previous Clinical Trials
140 Total Patients Enrolled
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