A Study of MEDI5083 Alone and in Combination with Durvalumab in Selected Advanced Solid Tumors
Study identifier:D6840C00001
ClinicalTrials.gov identifier:NCT03089645
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone and in Combination with Durvalumab in Selected Advanced Solid Tumors
Medical condition
Advanced Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
38
Study type
Interventional
Age
18 Years - 101 Years
Date
Study Start Date: 21 Mar 2017
Primary Completion Date: 23 Jun 2020
Study Completion Date: 23 Jun 2020
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2021 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part 1: MEDI5083 Dose 1 Q2W + Durvalumab Dose 1 Q4W Participants will receive MEDI5083 Dose 1 subcutaneously (SC) every 2 weeks (Q2W) for 4 doses, followed by monotherapy with durvalumab Dose 1 intravenously (IV) every 4 weeks (Q4W) until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. | Biological/Vaccine: MEDI5083 Participants will receive SC MEDI5083 doses Q2W according to the arms. Biological/Vaccine: Durvalumab Participants will receive durvalumab Dose 1 IV Q4W according to the arms. |
| Experimental: Part 1: MEDI5083 Dose 2 Q2W + Durvalumab Dose 1 Q4W Participants will receive MEDI5083 Dose 2 SC Q2W for 4 doses, followed by monotherapy with durvalumab Dose 1 IV Q4W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. | Biological/Vaccine: MEDI5083 Participants will receive SC MEDI5083 doses Q2W according to the arms. Biological/Vaccine: Durvalumab Participants will receive durvalumab Dose 1 IV Q4W according to the arms. |
| Experimental: Part 1: MEDI5083 Dose 3 Q2W + Durvalumab Dose 1 Q4W Participants will receive MEDI5083 Dose 3 SC Q2W for 4 doses, followed by monotherapy with durvalumab Dose 1 IV Q4W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. | Biological/Vaccine: MEDI5083 Participants will receive SC MEDI5083 doses Q2W according to the arms. Biological/Vaccine: Durvalumab Participants will receive durvalumab Dose 1 IV Q4W according to the arms. |
| Experimental: Part 1: MEDI5083 Dose 4 Q2W + Durvalumab Dose 1 Q4W Participants will receive MEDI5083 Dose 4 SC Q2W for 4 doses, followed by monotherapy with durvalumab Dose 1 IV Q4W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. | Biological/Vaccine: MEDI5083 Participants will receive SC MEDI5083 doses Q2W according to the arms. Biological/Vaccine: Durvalumab Participants will receive durvalumab Dose 1 IV Q4W according to the arms. |
| Experimental: Part 2: MEDI5083 Dose 1 Q2W + Durvalumab Dose 1 Q4W Participants will receive MEDI5083 Dose 1 SC Q2W for 4 doses with concurrent durvalumab Dose 1 IV Q4W, followed by monotherapy with durvalumab Dose 1 IV Q4W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. | Biological/Vaccine: MEDI5083 Participants will receive SC MEDI5083 doses Q2W according to the arms. Biological/Vaccine: Durvalumab Participants will receive durvalumab Dose 1 IV Q4W according to the arms. |
| Experimental: Part 2: MEDI5083 Dose 2 Q2W + Durvalumab Dose 1 Q4W Participants will receive MEDI5083 Dose 2 SC Q2W for 4 doses with concurrent durvalumab Dose 1 IV Q4W, followed by monotherapy with durvalumab Dose 1 IV Q4W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first. | Biological/Vaccine: MEDI5083 Participants will receive SC MEDI5083 doses Q2W according to the arms. Biological/Vaccine: Durvalumab Participants will receive durvalumab Dose 1 IV Q4W according to the arms. |
Contacts
Investigators
Principal Investigator
MedImmune LLC
Sponsor
