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VIP943

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Vincerx Pharma, Inc.|Trials Updated: Nov 15, 2024

VIP943 target and mechanism

ModalitySmall molecule

Also known as VIP943 (QW)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

VIP943 clinical trials

VIP943 · 1 trial · 3 indications

Phase 1 1
NCT06034275Study of VIP943 in Subjects With Advanced CD123+ Hematologic MalignanciesAcute Myeloid Leukemia
RECRUITING36 Analytics
PHASE1RECRUITING
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of DLT (Dose limit toxicity) of VIP943
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

Secondary Endpoints

Response rate to VIP943 as assessed by investigators using disease-specific response criteria
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
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
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation of VIP943 (QW)EXPERIMENTALSubjects 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).
Dose Escalation of VIP943 (BIW)EXPERIMENTALSubjects 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 twice weekly (BIW).

Interventions

NameTypeDescription
VIP943 (QW)DRUGVIP943 will be administered by IV Infusion weekly
VIP943 (BIW)DRUGVIP943 will be administered by IV Infusion bi-weekly
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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 ...

Countries:United States
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Frequently asked questions about VIP943

What is VIP943 used for?

VIP943 is an investigational small molecule being studied for the treatment of acute myeloid leukemia, a cancer of the blood and bone marrow. It is also being evaluated in B-cell acute lymphoblastic leukemia and high-risk myelodysplastic syndrome. It is not approved for any indication and remains in clinical development.

Who is developing VIP943?

VIP943 is being developed by Vincerx Pharma, Inc., a clinical-stage biopharmaceutical company that trades under the ticker symbol VINC. Vincerx is the sponsor of the ongoing clinical program evaluating VIP943 in patients with advanced hematologic malignancies.

What phase is VIP943 in?

VIP943 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 program is designed to evaluate the drug in patients with advanced CD123-positive hematologic malignancies.

What clinical trials is VIP943 in?

VIP943 is being studied in one active clinical trial, NCT06034275, titled Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies. The trial is currently recruiting and plans to enroll approximately 36 participants aged 18 years and older in the United States.

What types of cancer is the VIP943 trial enrolling?

The NCT06034275 trial is enrolling patients with acute myeloid leukemia, B-cell acute lymphoblastic leukemia, and high-risk myelodysplastic syndrome. Enrollment targets approximately 36 adult participants across sites in the United States, and the study is currently recruiting.

Is VIP943 the same as VIP943 (QW)?

Yes, VIP943 (QW) is an alternative name for VIP943, the investigational small molecule developed by Vincerx Pharma. Both names refer to the same compound being studied in the Phase 1 trial NCT06034275 for advanced CD123-positive hematologic malignancies.