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MEDI1873

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Jan 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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02583165A Study in Adult Subjects With Select Advanced Solid TumorsPHASE1 COMPLETED 40 — — Nov 9, 2015Dec 19, 2018Jan 8, 201910 United States
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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 months after last dose of MEDI1873

The maximum tolerated dose (MTD)/highest protocol-defined dose level in the absence of establishing an MTD will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, DLTs, 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 4.5 years
Disease control rate (DCR)
Estimated to be from time of informed consent up to 4.5 years
Duration of response (DoR)
Estimated to be from time of informed consent up to 4.5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Monotherapy armEXPERIMENTALMEDI1873
Interventions
NameTypeDescription
MEDI1873BIOLOGICALSubjects will receive MEDI1873 by intravenous administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * All subjects must consent to provide archived tumor specimen * Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease. * At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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