Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-06 @ 10:25 PM
Study NCT ID:
NCT04613492
Status:
TERMINATED
Last Update Posted:
2025-06-24
First Post:
2020-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors
Sponsor:
AstraZeneca
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early due to lack of efficacy and absence of biomarker evidence of MEDI9253's impact on the tumors.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-002294-96 | EUDRACT_NUMBER | None | View |