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This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in combination with erlotinib or cetuximab administered to patients with certain types of cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab |
|
| Cohort 2 | Experimental | Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab |
|
| Cohort 3 | Experimental | Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1400 | Drug |
| ||
| Erlotinib |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab | Safety will be assessed through analysis of laboratory data, physical examination findings and vital signs according to the schedule of assessments, in addition to the spontaneous reporting of adverse events according to CTCAE version 4. | Day 1 - Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) | Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab | Day 1 to Day 28 |
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Inclusion Criteria include, but are not limited to, the following:
Exclusion Criteria include, but are not limited to, the following:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Monica | California | United States | ||||
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| Drug |
|
| Cetuximab | Drug |
|
| Atlanta |
| Georgia |
| United States |
| Detroit | Michigan | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| San Antonio | Texas | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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