A Study of MEDI9253 in combination with durvalumab in select solid tumors
Study identifier:D7880C00001
ClinicalTrials.gov identifier:NCT04613492
EudraCT identifier:2020-002294-96
CTIS identifier:N/A
Recruitment Complete
Official Title
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
Medical condition
Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
37
Study type
Interventional
Age
18 Years - 101 Years
Date
Study Start Date: 02 Dec 2020
Estimated Primary Completion Date: 26 Nov 2024
Estimated Study Completion Date: 26 Nov 2024
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single dose MEDI9253, sequential Durvalumab Various dose level cohorts for single dose MEDI9253 with sequential Durvalumab dosing | Biological/Vaccine: MEDI9253 Participants will receive either Single dose MEDI9253 or Multiple Dose MEDI9253; sequentially or concurrent with Durvalumab Biological/Vaccine: Durvalumab Durvalumab treatment will be started sequentially or concurrently with MEDI9253 |
| Experimental: Multiple dose MEDI9253, sequential Durvalumab Various dose level cohorts for multiple dose MEDI9253 with sequential Durvalumab dosing; | Biological/Vaccine: MEDI9253 Participants will receive either Single dose MEDI9253 or Multiple Dose MEDI9253; sequentially or concurrent with Durvalumab Biological/Vaccine: Durvalumab Durvalumab treatment will be started sequentially or concurrently with MEDI9253 |
| Experimental: Multiple dose MEDI9253, concurrent Durvalumab Various dose level cohorts for multiple dose MEDI9253 with concurrent Durvalumab dosing. | Biological/Vaccine: MEDI9253 Participants will receive either Single dose MEDI9253 or Multiple Dose MEDI9253; sequentially or concurrent with Durvalumab Biological/Vaccine: Durvalumab Durvalumab treatment will be started sequentially or concurrently with MEDI9253 |
