The purpose of this study is to determine if IMC-1121B is safe for patients, and to determine the best dose of IMC-1121B to give to patients.
The purpose of this study is to establish the safety profile and the maximum tolerated dose (MTD) of the anti-VEGFR-2 monoclonal antibody IMC-1121B administered weekly in patients with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
37
Cohort 1 2 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period.
Cohort 2 4 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period.
Cohort 3 6 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period.
ImClone Investigational Site
Aurora, Colorado, United States
ImClone Investigational Site
Philadelphia, Pennsylvania, United States
Number of participants with Adverse Events (AEs)
Time frame: 6 weeks
Maximum Tolerated Dose
Time frame: 6 weeks
Maximum concentration (Cmax), cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Minimum concentration (Cmin), cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Area under concentration (AUC), cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Half-life (t 1/2), cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Serum Anti-IMC-1121B Antibody Assessment (immunogenicity)
Time frame: 6 weeks
Change in tumor size from Baseline Measurement
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cohort 4 8 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period.
Cohort 5 10 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period.
Cohort 6 13 mg/kg once a week for 4 weeks, followed by a 2-week observation period.
Cohort 7 16 mg/kg once a week for 4 weeks, followed by a 2-week observation period.