Study identifier:D7880C00001
ClinicalTrials.gov identifier:NCT04613492
EudraCT identifier:2020-002294-96
CTIS identifier:N/A
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
Solid Tumors
Phase 1
No
-
All
40
Interventional
18 Years - 101 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2024 by AstraZeneca
AstraZeneca
-
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 |