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VIP943

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06034275Study of VIP943 in Subjects With Advanced CD123+ Hematologic MalignanciesPHASE1 RECRUITING 36Sep 13, 2023Dec 31, 2025Nov 15, 20245 United States
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06034275primaryCompletionDate: changed
LOWMay 24, 2026NCT06034275studyFirstPostDate: changed