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
-
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.
Up to approximately 192 participants may be assigned to study intervention in the study across approximately 30 sites globally.
Location
Location
Saint Louis, MO, United States, 63110
Location
New York, NY, United States, 10032
Location
Pittsburgh, PA, United States, 15232
Location
New York, NY, United States, 10065
Location
Buffalo, NY, United States, 14263
Location
Bordeaux, France, 33076
Location
Villejuif, France, 94800
Location
Toulouse, France, 31100
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 |
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