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XmAb18087

Phase 1

Neuroendocrine Tumor | Monoclonal antibody | Oncology |Xencor, Inc.|Last Updated: May 10, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment62
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03411915A Study of XmAb®18087 in Subjects With NET and GISTPHASE1 COMPLETED 62Jan 22, 2018Oct 26, 2021May 10, 202216 United States
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Study Endpoints
Primary Endpoints
Determine the safety and tolerability profile of XmAb18087
84 Days

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

Identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087
84 Days

Establishing a safe and tolerable dose of XmAb18087 administered by intravenous (IV) dosing in NET and GIST patients

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XmAb18087EXPERIMENTALXmAb18087 administered on days 1, 8, 15, and 22 of each 28-day cycle for a total of 3 cycles
Interventions
NameTypeDescription
XmAb18087BIOLOGICALmonoclonal bispecific antibody
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Histologically or cytologically confirmed well differentiated low or intermediate grade (World Health Organization \[WHO\] Grade 1 or 2) NET of pancreatic, gastrointestinal, lung, or undetermined origin that is locally advanced or metastatic and has progressed within the past ...

Countries:United States
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