Trials / Completed
CompletedNCT03089645
MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.
A Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone or in Combination With Durvalumab, Tremelimumab, and/or Docetaxel in Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years – 101 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a global Phase 1, first-time-in-human, multicenter, dose-escalation and dose-expansion study of MEDI5083 alone or in combination with Durvalumab, Tremelimumab, and/or Docetaxel.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-03-21
- Primary completion
- 2020-06-23
- Completion
- 2020-06-23
- First posted
- 2017-03-24
- Last updated
- 2020-07-27
Locations
8 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03089645. Inclusion in this directory is not an endorsement.