This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Number of participants with dose limiting toxicities
Time frame: Up to 2 years
Number of participants with adverse events
Time frame: Up to 2 years
Area under the plasma concentration versus time curve
Determine the amount of IMGN289 in participants blood (pharmacokinetics)
Time frame: Up to 2 years
Peak plasma concentration (Cmax) of IMGN289
Determine the amount of IMGN289 in participants blood (pharmacokinetics)
Time frame: Up to 2 years
Presence of Human Anti Human Antibody and Human Anti Drug Antibody
Assess whether participants develop an immune response to IMGN289
Time frame: Up to 2 years
Tumor measurements per RECIST 1:1
Assess preliminary anti-tumor activity
Time frame: Up to 2 years
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