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MEDI9090

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Jan 14, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

MEDI9090 · 1 trial · 1 indication

Phase 1 1
NCT02900157Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED42 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of subjects reporting infusion related reactions
First dose of study medication through 30 days after the first dose of study medication
Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090
First dose of study medication through 6 months after the last dose of study medication

Secondary Endpoints

Individual MEDI9090 concentrations
First dose of study medication through 3 months after the last dose of study medication
Number of subjects reporting adverse events
Screening through 3 months after last dose of study medication
Number of subjects reporting serious adverse events
Screening through 3 months after the last dose of study medication
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEDI9090EXPERIMENTAL -

Interventions

NameTypeDescription
MEDI9090BIOLOGICALMEDI9090 will be administered by IV infusion
DurvalumabBIOLOGICALDurvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Male and female subjects * 18 years and older * Must have histologic documentation of advanced solid tumors * Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option Exclusion Criteria: * Concurren...

Countries:United StatesJapan
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about MEDI9090

What is MEDI9090 used for?

MEDI9090 is an investigational monoclonal antibody being developed for the treatment of advanced solid tumors. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with advanced solid tumors to evaluate its safety and pharmacokinetics.

Who makes MEDI9090?

MEDI9090 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and pharmacokinetics of MEDI9090 in patients with advanced solid tumors.

What phase is MEDI9090 in?

MEDI9090 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial is designed to evaluate the safety and pharmacokinetics of MEDI9090 in patients with advanced solid tumors.

What clinical trials is MEDI9090 in?

MEDI9090 has one completed clinical trial, registered under the identifier NCT02900157. The trial was a Phase 1 study titled 'Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors.' It enrolled 42 participants in the United States and Japan, with a minimum age of 18 years.

Is MEDI9090 FDA approved?

MEDI9090 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on evaluating safety and pharmacokinetics, and the drug has not yet progressed to later-stage trials or received regulatory approval.