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
Terminated/Withdrawn
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
40
Study type
Interventional
Age
18 Years - 101 Years
Date
Study Start Date: 02 Dec 2020
Primary Completion Date: 31 May 2024
Study Completion Date: 31 May 2024
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 May 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI9253 Single Dose Level 1 + Durvalumab 1500 mg Q4W Participants will receive intravenous (IV) infusion of a single dose of MEDI9253 dose level 1 on Day 1. After 14 days (+7 days) of MEDI9253 dose, participants will receive IV durvalumab at 1500 mg once every 4 weeks (Q4W) until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years. | Biological/Vaccine: MEDI9253 Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab Biological/Vaccine: Durvalumab Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253 |
| Experimental: MEDI9253 Single Dose Level 2 + Durvalumab 1500 mg Q4W Participants will receive IV infusion of a single dose of MEDI9253 dose level 2 on Day 1. After 14 days (+7 days) of MEDI9253 dose, participants will receive IV durvalumab at 1500 mg Q4W until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years. | Biological/Vaccine: MEDI9253 Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab Biological/Vaccine: Durvalumab Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253 |
| Experimental: MEDI9253 Multiple Dose Level 2 + Durvalumab 1500 mg Q4W Participants will receive IV infusion of 3 weekly doses (±2 days) of MEDI9253 dose level 2 over a maximum of 17 days, with a minimum of 5 days between each dose. After 14 days (+7 days) post the last dose of MEDI9253, participants will receive IV durvalumab at 1500 mg Q4W until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years. | Biological/Vaccine: MEDI9253 Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab Biological/Vaccine: Durvalumab Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253 |
| Experimental: MEDI9253 Multiple Dose Level 3 + Durvalumab 1500 mg Q4W Participants will receive IV infusion of 3 weekly doses (±2 days) of MEDI9253 dose level 3 over a maximum of 17 days, with a minimum of 5 days between each dose. After 14 days (+7 days) post the last dose of MEDI9253, participants will receive IV durvalumab at 1500 mg Q4W until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years. | Biological/Vaccine: MEDI9253 Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab Biological/Vaccine: Durvalumab Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253 |
| Experimental: MEDI9253 Multiple Dose Level 3+Durva 1500 mg Q4W Seq 3A-DESENS Participants will receive IV infusion of 3 weekly doses (±2 days) of MEDI9253 dose level 3 over a maximum of 17 days, with a minimum of 5 days between each dose (first dose was administered at dose level 2 while second and third doses were administered at dose level 3). After 14 days (+7 days) post the last dose of MEDI9253, participants will receive IV durvalumab at 1500 mg Q4W until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years. | Biological/Vaccine: MEDI9253 Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab Biological/Vaccine: Durvalumab Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253 |
| Experimental: MEDI9253 Multiple Dose Level 3+Durva 1500 mg Q4W Conc3B-DESENS Participants will receive IV infusion of 3 weekly doses (±2 days) of MEDI9253 dose level 3 over a maximum of 17 days, with a minimum of 5 days between each dose (first dose was administered at dose level 2 while second and third doses were administered at dose level 3) along with IV infusion of durvalumab 1500 mg Q4W starting from Day 8 (on the same day of second dose of MEDI9253) until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years. | Biological/Vaccine: MEDI9253 Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab Biological/Vaccine: Durvalumab Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253 |
