A Phase 1, Open-label, Dose-escalation and Expansion Study of MEDI1191 Administered Intratumorally as Monotherapy and in Combination with Durvalumab in Subjects with Advanced Solid Tumors. Sub-study title: CD8+ Imaging Sub-study Protocol - D8510C00001 / ICON # 0597/0115

MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC0 sites14 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC

•Please note that due to removing inclusion/ exclusion criteria not relevant for
•the protocol conducted in The Netherlands, the numbers deviate from those in
•the Main Protocol.
•Subjects must meet all of the following criteria:
•1\. Subjects \>\= 18 years of age.
•2\. Have given written informed consent prior to any study prior to performing
•any protocol related procedures, including screening evaluations.
•3\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\.
•4\. Have at least 1 measurable lesion, other than the planned injected
•lesion(s), using standard techniques by RECIST v1\.1\. Injected tumor lesion(s)

•Please note that due to removing inclusion/ exclusion criteria not relevant for
•the protocol conducted in The Netherlands, the numbers deviate from those in
•the Main Protocol.
•Any of the following would exclude the subject from participation in the study:
•1\. Prior IL\-12 either alone or as part of a treatment regimen.
•2\. Concurrent enrollment in another clinical study within 30 days prior to
•treatment administration, unless it is an observational (non interventional)
•clinical study or the follow\-up period of an interventional study.
•3\. Receipt of live attenuated vaccines within 30 days prior to the first dose
•of study treatment. Subjects who receive study treatment should not receive