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MEDI1191

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

MEDI1191 · 1 trial · 2 indications

Phase 1 1
NCT03946800A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid TumorsSolid Tumors
COMPLETED61 Analytics
PHASE1COMPLETED
A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors
Solid Tumors
NCT0394680061
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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 to 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 (matched to "Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about MEDI1191

What is MEDI1191 used for in solid tumors?

MEDI1191 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors and cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy.

What does MEDI1191 target?

MEDI1191 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. As an investigational therapy, its mechanism of action is not publicly detailed, and further research is needed to understand how it interacts with the immune system or tumor cells.

Who makes MEDI1191?

MEDI1191 is being developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research to evaluate the drug's potential in treating solid tumors.

What phase is MEDI1191 in?

MEDI1191 is currently in Phase 1 clinical development. This early-stage trial focuses on assessing the drug's safety, tolerability, and dosing in patients with advanced solid tumors. It is not yet approved by the FDA or other regulatory bodies, and further studies are required before it can be considered for market authorization.

What clinical trials is MEDI1191 in?

MEDI1191 has been studied in one completed Phase 1 clinical trial with the identifier NCT03946800. The trial, titled 'A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors,' enrolled 61 participants across the United States and Spain. The study was controlled but not randomized or double-blinded.

Is MEDI1191 the same as durvalumab?

No, MEDI1191 is not the same as durvalumab. Durvalumab is a separate immunotherapy drug also developed by AstraZeneca, and it was used in combination with MEDI1191 in the clinical trial NCT03946800. The two drugs have distinct mechanisms and are being evaluated together to assess potential synergistic effects in treating solid tumors.