The purpose of this study is to determine if IMC-11F8 is safe for patients, and also to determine the best dose of IMC-11F8 to give to patients.
The purpose of this study is to establish the safety profile and the maximum tolerated dose (MTD) of the fully human anti-EGFR monoclonal antibody IMC-11F8 in patients with solid tumors who have filed standard therapy or for whom no standard therapy is available.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
60
ImClone Investigational Site
Amsterdam, Netherlands
ImClone Investigational Site
Utrecht, Netherlands
Number of Participants with Adverse Events
Time frame: Approximately 24 Months
Maximum Tolerated Dose of IMC-11F8
Time frame: Approximately 24 Months
Area under the Time Concentration Curve (AUC)
Time frame: Approximately 24 Months
Maximum concentration (Cmax)
Time frame: Approximately 24 Months
Half-life (t 1/2)
Time frame: Approximately 24 Months
Serum Anti-IMC-11F8 Antibody Assessment
Time frame: Approximately 24 Months
Change from baseline in Antitumor Activity
Time frame: Approximately 24 Months
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Cohort 4 600 mg I.V.
Cohort 5 800 mg I.V.
Cohort 6 1000 mg I.V.
Cohort 1 100 mg I.V.
Cohort 2 200 mg I.V.
Cohort 3 400 mg I.V.
Cohort 4 600 mg I.V.
Cohort 5 800 mg I.V.
Cohort 6 1000 mg I.V.