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AZD9150, Durvalumab

Phase 1

Advanced Solid Malignancies | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 24, 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 Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03394144Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid MalignanciesPHASE1 COMPLETED 11 — — Jan 30, 2018Apr 12, 2019Jun 24, 20192 Japan
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Study Endpoints
Primary Endpoints
Safety and tolerability in terms of adverse events
From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.

Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters

Secondary Endpoints
Maximum plasma concentration (Cmax)
From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.
Overall response rate
Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
Duration of Response
Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
C1:AZD9150, C2:AZD9150+DurvalumabEXPERIMENTALAfter confirmed safety with Cohort 1, Cohort 2 will open
Interventions
NameTypeDescription
AZD9150, DurvalumabDRUGAfter confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT
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Eligibility Criteria
Age Range20 Years — 120 Years
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: * Male and female patients must be at least 20 years of age. * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1. * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded...

Countries:Japan
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