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MEDI1191

Phase 1

Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Oct 2, 2024

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 Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03946800A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid TumorsPHASE1 COMPLETED 61 — — May 8, 2019Aug 24, 2023Oct 2, 202411 United States, Spain
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Study Endpoints
Primary Endpoints
Number of subjects with adverse events (AEs) serious adverse events (SAEs) and dose limiting toxicities (DLTs).
From time of informed consent until 90 days after the last dose of investigational product (MEDI1191 or durvalumab).

The occurrence of DLTs will be used to establish the maximum tolerated dose (MTD) of MEDI1191.

Objective response rate (ORR) in patients within expansion arms.
Estimated to be from time of informed consent up to 3.5 years.

The ORR is defined as the proportion of subjects with confirmed response (CR) or confirmed partial response (PR).

Secondary Endpoints
Number of advanced solid tumor subjects with adverse events (AEs) serious adverse events (SAEs) and dose limiting toxicities (DLTs).
From time of informed consent until 90 days after the last dose of investigational product (MEDI1191 or durvalumab).
Objective response rate (ORR) in advanced solid tumor subjects.
Estimated to be from time of informed consent up to 3.5 years.
Disease Control Rate (DCR).
Estimated to be from time of informed consent up to 3.5 years.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MEDI1191 escalation in combination with durvalumabEXPERIMENTALMEDI1191 escalation in sequential and concurrent combination with durvalumab
MEDI1191 expansion in combination with durvalumabEXPERIMENTALMEDI1191 expansion in concurrent combination with durvalumab
Interventions
NameTypeDescription
MEDI1191BIOLOGICALSubjects will receive MEDI1191 (at least twice)
DurvalumabBIOLOGICALSubject will receive durvalumab every 4 weeks
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Eligibility Criteria
Age Range18 Years — 101 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * ECOG 0 to 1. * Adequate organ function within 2 weeks of starting study treatment. * Prior to the first dose of MEDI1191, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic. * Cessation of systemic corticosteroids at doses exc...

Countries:United StatesSpain
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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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