Study identifier:D6450C00001
ClinicalTrials.gov identifier:NCT03889275
EudraCT identifier:N/A
CTIS identifier:N/A
An Open-label Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI5395 in Combination with Durvalumab in Subjects with Select Advanced Solid Tumors.
Advanced Solid Tumors
Phase 1
No
-
All
39
Interventional
18 Years - 101 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2022 by MedImmune, LLC
MedImmune, LLC
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Sequential MEDI5395 and durvalumab administered sequentially | Biological/Vaccine: MEDI5395 Subjects will receive multiple doses of MEDI5395 over several days. Biological/Vaccine: Durvalumab Durvalumab will be administered periodically for a maximum of 2 years or until radiologically confirmed disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity Other Name: Imfinzi |
Experimental: Concurrent MEDI5395 and durvalumab administered concurrently | Biological/Vaccine: MEDI5395 Subjects will receive multiple doses of MEDI5395 over several days. Biological/Vaccine: Durvalumab Durvalumab will be administered periodically for a maximum of 2 years or until radiologically confirmed disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity Other Name: Imfinzi |