Study identifier:AMP-514-01
ClinicalTrials.gov identifier:NCT02013804
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0680 (AMP-514) in Subjects with Advanced Malignancies
Advanced Malignancies
Phase 1
No
MEDI0680 (AMP-514)
All
58
Interventional
18 Years - 99 Years
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2019 by MedImmune, LLC
MedImmune, LLC
Amplimmune
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: MEDI0680 0.1 mg/kg Q3W Participants will receive intravenous (IV) infusion of MEDI0680 0.1 milligram / kilogram once in every three weeks (Q3W) on Day 1 of each 21-day treatment cycle for 12 months or confirmed progressive disease. | Drug: MEDI0680 (AMP-514) Participants will receive IV infusion of MEDI0680. |
Experimental: MEDI0680 0.5 mg/kg Q3W Participants will receive IV infusion of MEDI0680 0.5 mg/kg Q3W on Day 1 of each 21-day treatment cycle for 12 months or confirmed progressive disease. | Drug: MEDI0680 (AMP-514) Participants will receive IV infusion of MEDI0680. |
Experimental: MEDI0680 2.5 mg/kg Q3W Participants will receive IV infusion of MEDI0680 2.5 mg/kg Q3W on Day 1 of each 21-day treatment cycle for 12 months or confirmed progressive. | Drug: MEDI0680 (AMP-514) Participants will receive IV infusion of MEDI0680. |
Experimental: MEDI0680 10 mg/kg Q3W Participants will receive IV infusion of MEDI0680 10 mg/kg Q3W on Day 1 of each 21-day treatment cycle for 12 months or confirmed progressive disease. | Drug: MEDI0680 (AMP-514) Participants will receive IV infusion of MEDI0680. |
Experimental: MEDI0680 20 mg/kg Q3W Participants will receive IV infusion of MEDI0680 20 mg/kg Q3W on Day 1 of each 21-day treatment cycle for 12 months or confirmed progressive disease. | Drug: MEDI0680 (AMP-514) Participants will receive IV infusion of MEDI0680. |
Experimental: MEDI0680 10 mg/kg Q2W Participants will receive IV infusion of MEDI0680 10 mg/kg once every two weeks (Q2W) on Days 1 and 15 of each 28- day treatment cycle for 12 months or confirmed progressive disease. | Drug: MEDI0680 (AMP-514) Participants will receive IV infusion of MEDI0680. |
Experimental: MEDI0680 20 mg/kg Q2W Participants will receive IV infusion of MEDI0680 20 mg/kg Q2W on Days 1 and 15 of each 28- day treatment cycle for 12 months or confirmed progressive disease. | Drug: MEDI0680 (AMP-514) Participants will receive IV infusion of MEDI0680. |
Experimental: MEDI0680 20 mg/kg QWx2 Participants will receive weekly 2 doses of IV infusion of MEDI0680 20 mg/kg QWx2 (Days 1 and 8) in Cycle 1 and followed by Q2W dosing from Day 15 for a 28-day treatment cycle for 12 months or confirmed progressive disease. | Drug: MEDI0680 (AMP-514) Participants will receive IV infusion of MEDI0680. |
Experimental: MEDI0680 20 mg/kg QWx4 Participants will receive weekly 4 doses of IV infusion of MEDI0680 20 mg/kg QWx4 (Days 1, 8, 15, and 22) in Cycle 1 and followed by Q2W dosing from Day 29 for a 28-day treatment cycle for 12 months or confirmed progressive disease. | Drug: MEDI0680 (AMP-514) Participants will receive IV infusion of MEDI0680. |