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XmAb14045

Phase 1

Acute Myelogenous Leukemia | Monoclonal antibody | Oncology |Xencor, Inc.|Last Updated: Mar 8, 2022

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02730312PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic MalignanciesPHASE1 COMPLETED 120Aug 1, 2016Sep 1, 2021Mar 8, 20229 United States
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Study Endpoints
Primary Endpoints
Safety as determined by the number of participants with treatment-related adverse events
Baseline Day 1 through Day 56

Treatment-related adverse events as assessed by CTCAE v4.03

Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing
Baseline Day 1 through Day 56
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XmAb14045EXPERIMENTALBiological/Vaccine: XmAb14045 Administered IV weekly up to 8 weeks
Interventions
NameTypeDescription
XmAb14045BIOLOGICALAdministered IV weekly up to 8 weeks, with or without step-up dosing
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Diagnosis of 1 of the following diseases: * Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but excluding acute promyelocytic leukemia) * B-cell ALL * BPDCN * CML in blast phase, resistant or intolerant to tyrosine kinase inhibitor thera...

Countries:United States
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