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MEDI9090

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Jan 14, 2021

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
UNCONTROLLED
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02900157Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid TumorsPHASE1 COMPLETED 42Aug 9, 2016Jan 23, 2020Jan 14, 20218 United States, Japan
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Study Endpoints
Primary Endpoints
Number of subjects reporting infusion related reactions
First dose of study medication through 30 days after the first dose of study medication
Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090
First dose of study medication through 6 months after the last dose of study medication
Secondary Endpoints
Individual MEDI9090 concentrations
First dose of study medication through 3 months after the last dose of study medication
Number of subjects reporting adverse events
Screening through 3 months after last dose of study medication
Number of subjects reporting serious adverse events
Screening through 3 months after the last dose of study medication
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MEDI9090EXPERIMENTAL -
Interventions
NameTypeDescription
MEDI9090BIOLOGICALMEDI9090 will be administered by IV infusion
DurvalumabBIOLOGICALDurvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Male and female subjects * 18 years and older * Must have histologic documentation of advanced solid tumors * Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option Exclusion Criteria: * Concurren...

Countries:United StatesJapan
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