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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
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| Cohort 3a | Experimental |
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| Cohort 3b | Experimental |
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| Cohort 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nesvacumab (REGN910/ SAR307746) | Drug | Dose level 1 |
| |
| nesvacumab (REGN910/ SAR307746) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) | Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) administered in combination with aflibercept (ziv-aflibercept) in patients with advanced solid malignancies | Day 1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) | To assess PK parameters such as concentration of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept). | Day 1 to Day 170 |
| Immunogenicity | To assess the anti-drug antibodies of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept) |
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Inclusion Criteria:
Inclusion criteria include, but are not limited to, the following:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Indianapolis | Indiana | United States | ||||
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| Drug |
Dose level 2 |
|
| nesvacumab (REGN910/ SAR307746) | Drug | Dose level 3 |
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| aflibercept (ziv-aflibercept) | Drug | Dose level 1 |
|
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| aflibercept (ziv-aflibercept) | Drug | Dose level 2 |
|
|
| Day 1 to Day 170 |
| Antitumor activity | Objective tumor response according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 | Day 1 to Day 170 |
| Pharmacodynamics (PD) | Target inhibition biomarker changes, serum tumor markers | Day 1 to Day 170 |
| New York |
| New York |
| United States |
| Oklahoma City | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| San Antonio | Texas | United States |
| Toronto | Canada |
| ID | Term |
|---|---|
| C533178 | aflibercept |
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