MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.
NCT03089645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2020-07-27
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
MEDI5083 monotherapy
Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab
- BIOLOGICAL
-
MEID5083 with Durvalumab or Tremelimumab
Sequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab
- BIOLOGICAL
-
Medi5083 with Durvalumab and Docetaxel
Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel
Sponsors & Collaborators
-
MedImmune LLC
lead INDUSTRY
Principal Investigators
-
MedImmune LLC · Sponsor GmbH
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 101 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-21
- Primary Completion
- 2020-06-23
- Completion
- 2020-06-23
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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