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VIP943

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as VIP943 (QW)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

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. It is also being evaluated in patients with B-cell Acute Lymphoblastic Leukemia and High-risk Myelodysplastic Syndrome. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes VIP943?

VIP943 is being developed by Vincerx Pharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VINC. The company is conducting a Phase 1 clinical trial of VIP943 in patients with advanced CD123+ hematologic malignancies.

What phase is VIP943 in?

VIP943 is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is actively recruiting participants in the United States to evaluate the safety and efficacy of VIP943 in patients with certain hematologic malignancies.

What clinical trials is VIP943 in?

VIP943 is being studied in a Phase 1 clinical trial with the identifier NCT06034275. The trial is titled 'Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies' and is currently recruiting participants. The study is enrolling up to 36 patients with Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, or High-risk Myelodysplastic Syndrome.

Is VIP943 the same as VIP943 (QW)?

Yes, VIP943 is also known as VIP943 (QW). The designation 'QW' likely refers to a once-weekly dosing schedule being evaluated in the clinical trial. Both names refer to the same investigational drug being developed by Vincerx Pharma for the treatment of hematologic malignancies.