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MEDI9447

Phase 1

Advanced Solid Malignancies | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 8, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03736473A Phase I Study of MEDI9447 (Oleclumab) in Japanese PatientsPHASE1 COMPLETED 6Nov 7, 2018Jun 19, 2019Jul 8, 20191 Japan
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Study Endpoints
Primary Endpoints
Adverse event
From the informed consent to 90 days after the last dose

To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for MEDI9447

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
MEDI9447 monotherapyOTHERDose escalation of MEDI9447 monotherapy for patients with advanced solid malignancies
Interventions
NameTypeDescription
MEDI9447 (oleclumab)DRUGMEDI9447 administered intravenously
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Major Inclusion Criteria: * Adult subjects; age ≥ 20 years * Has a histologically confirmed solid malignancy that is refractory to standard therapy or for which no standard of care regimen currently exists * Subjects must have at least 1 lesion that is measureable using RECIST v1.1 * All subjects m...

Countries:Japan
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