MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.
Completed · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult subjects with advanced solid tumors.
Key facts
- Study ID
- NCT03089645
- Run by
- MedImmune LLC
- People needed
- 39
- Starts
- 2017-03-21
- Expected to finish
- 2020-06-23
- Last updated by the study team
- 2020-07-27
Who can join
Age: 18 and older, up to 101. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Hackensack, New Jersey, United States
- Research Site — Providence, Rhode Island, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Salt Lake City, Utah, United States
- Research Site — Clayton, Australia
- Research Site — Melbourne, Australia
- Research Site — Melbourne, Australia
- Research Site — Randwick, Australia
Full record on ClinicalTrials.gov
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