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MEDI6383

Phase 1

Recurrent or Metastatic Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Mar 13, 2019

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 Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02221960A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid TumorsPHASE1 COMPLETED 39Sep 15, 2014Jul 3, 2017Mar 13, 20198 United States, Australia
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Study Endpoints
Primary Endpoints
Safety
From time of informed consent through 12 weeks after last dose of investigational product

Primary endpoint will be the number (%) of subjects with adverse events and serious adverse events.

Secondary Endpoints
Preliminary Antitumor Activity
Duration of Study
Pharmacokinetics of MEDI6383 or MEDI6383/MEDI4736
From time of informed consent through 12 weeks after last dose of investigational product
Biomarker Activity
From time of informed consent through 12 weeks after last dose of investigational product
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Monotherapy ArmEXPERIMENTALMEDI6383
Combination ArmEXPERIMENTALMEDI6383 and MEDI4736
Interventions
NameTypeDescription
MEDI6383BIOLOGICALSubjects will receive MEDI6383 until disease progression or adverse event.
MEDI6383 and MEDI4736BIOLOGICALSubjects will recieve MEDI6383 and MEDI4736 until disease progression or adverse event.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Male and female subjects; age ≥ 18 2. Written informed consent must be obtained 3. Subjects must meet the following criteria: 1. Have recurrent or metastatic solid tumors 2. Must have received and have progressed, are refractory, or are intolerant to standard therapy a...

Countries:United StatesAustralia
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