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| ID | Type | Description | Link |
|---|---|---|---|
| CP12-0401 | Other Identifier | ImClone Systems | |
| I4T-IE-JVBM | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-1121B | Experimental | All patients will receive intravenous infusions of IMC-1121B with the dose depending on which cohort they are enrolled into. A minimum of three patients will be enrolled in each cohort. A completed patient will be either a patient who completes the 4-week treatment cycle and 2-week observation period (for a total of 6 weeks), or a patient who discontinues therapy for an IMC-1121B-related toxicity. Toxicity data for each cohort will be reviewed prior to dose escalation. When all patients complete a cohort, dose escalation to the next cohort will occur. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-1121B | Biological | Cohort 1 2 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | 6 weeks | |
| Maximum Tolerated Dose | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax), cohorts 1, 2, 3, 4, 5, 6. and 7 | 6 weeks | |
| Minimum concentration (Cmin), cohorts 1, 2, 3, 4, 5, 6. and 7 | 6 weeks | |
| Area under concentration (AUC), cohorts 1, 2, 3, 4, 5, 6. and 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Aurora | Colorado | 80045 | United States | ||
| ImClone Investigational Site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 1121B | Biological | Cohort 2 4 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period. |
|
| 1121B | Biological | Cohort 3 6 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period. |
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| 1121B | Biological | Cohort 4 8 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period. |
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| 1121B | Biological | Cohort 5 10 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period. |
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| 1121B | Biological | Cohort 6 13 mg/kg once a week for 4 weeks, followed by a 2-week observation period. |
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| 1121B | Biological | Cohort 7 16 mg/kg once a week for 4 weeks, followed by a 2-week observation period. |
|
| 6 weeks |
| Half-life (t 1/2), cohorts 1, 2, 3, 4, 5, 6. and 7 | 6 weeks |
| Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, 5, 6. and 7 | 6 weeks |
| Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, 5, 6. and 7 | 6 weeks |
| Serum Anti-IMC-1121B Antibody Assessment (immunogenicity) | 6 weeks |
| Change in tumor size from Baseline Measurement | 6 weeks |
| Philadelphia |
| Pennsylvania |
| 19111 |
| United States |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |