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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

Study Summary

This trial is testing a new drug to treat advanced blood cancers. It will determine the best safe dose for the drug.

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.Check my eligibility

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.See study design

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 below

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My cancer cells show CD123 presence.

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I can take care of myself and am up and about more than half of my waking hours.

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My leukemia or myelodysplastic syndrome has not responded to standard treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of DLT (Dose limit toxicity) of VIP943

Secondary outcome measures

Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943

Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943

Response rate to VIP943 as assessed by investigators using disease-specific response criteria

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).

0 / 3Eligibility criteria met

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a heightened risk associated with the stepped-up administration of VIP943?

"Due to the preliminary nature of Phase 1 trials, VIP943 was rated a 1 for safety by our team at Power as there is limited supporting evidence regarding its efficacy and security."

Answered by AI

Is there currently an enrollment process for this investigation?

"Data obtained from clinicaltrials.gov reveals that this trial, initially posted on September 13th 2023, is actively enlisting people to participate. The listing was most recently modified two days ago (September 15th)."

Answered by AI

What is the current sample size of this experiment?

"That is correct. Clinicaltrials.gov reports that, as of September 15th 2023, this clinical study has been actively recruiting patients since its posting on the 13th of September. 36 participants need to be registered from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

2023. "Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034275.