Trials / Terminated
TerminatedNCT04613492
A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors
An Open-label, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI9253, a Recombinant Newcastle Disease Virus Encoding Interleukin-12, in Combination With Durvalumab in Participants With Select Advanced/Metastatic Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 101 Years
- Healthy volunteers
- Not accepted
Summary
Study D7880C00001 is a first-in-human (FIH), Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of MEDI9253 in combination with durvalumab in adult participants with select advanced/metastatic solid tumors.
Detailed description
Up to approximately 192 participants may be assigned to study intervention in the study across approximately 30 sites globally.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MEDI9253 | Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab |
| BIOLOGICAL | Durvalumab | Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253 |
Timeline
- Start date
- 2020-12-02
- Primary completion
- 2024-05-31
- Completion
- 2024-05-31
- First posted
- 2020-11-03
- Last updated
- 2025-06-24
Locations
8 sites across 2 countries: United States, France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04613492. Inclusion in this directory is not an endorsement.