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MEDI6383

Phase 1

Recurrent or Metastatic Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Mar 13, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

MEDI6383 · 1 trial · 1 indication

Phase 1 1
NCT02221960A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid TumorsRecurrent or Metastatic Solid Tumors
COMPLETED39 Analytics
PHASE1COMPLETED
A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
Recurrent or Metastatic Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety
From time of informed consent through 12 weeks after last dose of investigational product

Primary endpoint will be the number (%) of subjects with adverse events and serious adverse events.

Secondary Endpoints

Preliminary Antitumor Activity
Duration of Study
Pharmacokinetics of MEDI6383 or MEDI6383/MEDI4736
From time of informed consent through 12 weeks after last dose of investigational product
Biomarker Activity
From time of informed consent through 12 weeks after last dose of investigational product
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Monotherapy ArmEXPERIMENTALMEDI6383
Combination ArmEXPERIMENTALMEDI6383 and MEDI4736

Interventions

NameTypeDescription
MEDI6383BIOLOGICALSubjects will receive MEDI6383 until disease progression or adverse event.
MEDI6383 and MEDI4736BIOLOGICALSubjects will recieve MEDI6383 and MEDI4736 until disease progression or adverse event.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Male and female subjects; age ≥ 18 2. Written informed consent must be obtained 3. Subjects must meet the following criteria: 1. Have recurrent or metastatic solid tumors 2. Must have received and have progressed, are refractory, or are intolerant to standard therapy a...

Countries:United StatesAustralia
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Recurrent or Metastatic Solid Tumors")

Frequently asked questions about MEDI6383

What is MEDI6383 used for?

MEDI6383 is an investigational monoclonal antibody being studied for the treatment of recurrent or metastatic solid tumors. It is intended for adult patients with select advanced solid tumors, as evaluated in a Phase 1 clinical trial.

Who makes MEDI6383?

MEDI6383 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy.

What phase is MEDI6383 in?

MEDI6383 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and potential efficacy in patients with advanced solid tumors.

What clinical trials is MEDI6383 in?

MEDI6383 has been studied in a Phase 1 clinical trial with the identifier NCT02221960. This trial evaluated MEDI6383 alone and in combination with MEDI4736 in adult subjects with select advanced solid tumors. The trial was completed and enrolled 39 participants.

Is MEDI6383 the same as MEDI4736?

No, MEDI6383 is not the same as MEDI4736. MEDI6383 is a separate investigational monoclonal antibody. In clinical trial NCT02221960, MEDI6383 was studied both alone and in combination with MEDI4736, which is another investigational agent developed by AstraZeneca.