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MEDI0562

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Jan 29, 2018

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 Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02318394A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid TumorsPHASE1 COMPLETED 56Mar 2, 2015Jan 9, 2018Jan 29, 201812 United States, South Korea
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Study Endpoints
Primary Endpoints
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
From time of informed consent through 12 weeks after last dose of MEDI0562

The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.

Secondary Endpoints
Objective response rate (ORR)
Estimated to be from time of informed consent up to 5 years
Maximum observed concentration (Cmax), area under the curve (AUC), clearance (CL) and terminal half-life of MEDI0562
From first dose of MEDI0562 through to 30 days after last dose of investigational product
Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
From first dose of MEDI0562 through to 30 days after last dose of investigational product
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Monotherapy ArmEXPERIMENTALMEDI0562 monotherapy
Interventions
NameTypeDescription
MEDI0562BIOLOGICALSubjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both stan...

Countries:United StatesSouth Korea
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