Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This is a global Phase 1, first-time-in-human, multicenter, open-label, dose-escalation and dose-expansion study of MEDI5083 alone and in combination with durvalumab.
Conditions
This trial is treating people with advanced solid cancers
Eligibility
Inclusion
- Age ≥ 18 years at the time of screening or age of consent according to local law
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically or cytologically confirmed metastatic or recurrent tumor types
- Subjects who have received prior immunotherapy may be eligible
- Subjects must have at least one measurable lesion
- Consent to provide archival tumor tissue and pre/on-treatment biopsies
- Adequate organ and marrow function
- Consent to use one highly effective method of contraception
Exclusion
- Receipt of any systemic anticancer therapy within 28 days prior to the first dose of MEDI5083
- Concurrent enrollment in another clinical study
- Active/prior autoimmune of inflammatory disorders
- History of immunodeficiency, solid organ transplant, or tuberculosis
- Known allergy/hypersensitivity to drug or components
- Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
MedImmune, LLC
Scientific Title
A Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone and in Combination With Durvalumab in Selected Advanced Solid Tumors
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