The purpose of this study is to determine if IMC-A12 is safe for patients, and also to determine the best dose of IMC-A12 to give to patients.
The purpose of this study is to establish the safety profile and maximum tolerated dose (MTD) of the anti-IGF-IR monoclonal antibody IMC-A12 administered every other week in patients with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
16
ImClone Investigational Site
Nashville, Tennessee, United States
Number of participants with Adverse Events (AEs)
Time frame: 8 weeks
Maximum Tolerated Dose
Time frame: 8 weeks
Maximum concentration (Cmax), cohorts 1, 2, 3, 4, and 5
Time frame: 8 weeks
Minimum concentration (Cmin), cohorts 1, 2, 3, 4, and 5
Time frame: 8 weeks
Area under concentration (AUC), cohorts 1, 2, 3, 4, and 5
Time frame: 8 weeks
Half-life (t 1/2), cohorts 1, 2, 3, 4, and 5
Time frame: 8 weeks
Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, and 5
Time frame: 8 weeks
Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, and 5
Time frame: 8 weeks
Serum Anti-IMC-A12 Antibody Assessment (immunogenicity)
Time frame: 8 weeks
Change in tumor size from Baseline Measurement
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cohort 4 21 mg/kg I.V., once every other week for 4 weeks
Cohort 5 27 mg/kg I.V., once every other week for 4 weeks