A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Advanced Solid Tumors
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation (3+3) study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI0639.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Adult Subjects With Advanced Solid Tumors|
- Determination of the MTD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Anti-Tumor [ Time Frame: 24 months ] [ Designated as safety issue: No ]Assessments of antitumor activity will be based on the objective response rate, disease control rate, duration of response, progression-free survival, and overall survival.
- Immunogenicity [ Time Frame: 24 months ] [ Designated as safety issue: No ]Immunogenicity The immunogenic potential of MEDI0639 will be assessed by summarizing the number and percentage of subjects who develop detectable antidrug antibody (ADA).
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6
MEDI0639 is an immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. MEDI0639 selectively binds to DLL4 and blocks its ability to bind to and activate signaling through the Notch receptors.
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation (3+3) study to evaluate the safety, tolerability, antitumor activity, PK, and immunogenicity of MEDI0639 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exist. Up to 63 subjects will be enrolled at approximately 3 to 5 study centers in North America.
|United States, Connecticut|
|New Haven, Connecticut, United States, 06519|
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|New York, New York, United States, 10016|
|United States, Texas|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||David Smith, MD||University of Michigan|