Study identifier:D8510C00001
ClinicalTrials.gov identifier:NCT03946800
EudraCT identifier:2020-005784-31
CTIS identifier:N/A
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
Solid Tumors
Phase 1
No
-
All
61
Interventional
18 Years - 101 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by MedImmune, LLC
MedImmune, LLC
-
To evaluate MEDI1191 administered intratumorally in sequential and concurrent combination with intravenous durvalumab in patients with solid tumors.
This is a multicenter, open-label study to evaluate MEDI1191 delivered by intratumoral injection in sequential and concurrent combination with intravenous durvalumab to subjects with solid tumors. The study has a dose escalation design using mTPI-2 to evaluate a range of doses.
Location
Location
Providence, RI, United States, 02903
Location
La Jolla, CA, United States, 92093
Location
Houston, TX, United States, 77030
Location
Bronx, NY, United States, 10461
Location
Los Angeles, CA, United States, 90025
Location
New York, NY, United States, 10029
Location
Los Angeles, CA, United States, 90089
Location
Barcelona, Spain, 08035
Arms | Assigned Interventions |
---|---|
Experimental: MEDI1191 escalation in combination with durvalumab MEDI1191 escalation in sequential and concurrent combination with durvalumab | Biological/Vaccine: MEDI1191 Subjects will receive MEDI1191 (at least twice) Biological/Vaccine: Durvalumab Subject will receive durvalumab every 4 weeks |
Experimental: MEDI1191 expansion in combination with durvalumab MEDI1191 expansion in concurrent combination with durvalumab | Biological/Vaccine: MEDI1191 Subjects will receive MEDI1191 (at least twice) Biological/Vaccine: Durvalumab Subject will receive durvalumab every 4 weeks |
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