Solid Tumors
Conditions
Brief summary
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.
Interventions
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Confirmed diagnosis of advanced solid malignancy. 2. ECOG performance status 0 - 1 3. Adequate hepatic, renal and bone marrow function 4. At least 3 weeks since last dose of chemotherapy, hormonal therapy or radiotherapy 5. At least 6 weeks since last dose of bevacizumab 6. At least 4 weeks since last surgery 7. At least 4 weeks since last dose of investigational treatment
Exclusion criteria
1. Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement 2. Patients with serious non healing wound or acute ulcer 3. Either systolic blood pressure \>150 mm Hg or diastolic blood pressure \>95 mm Hg 4. Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia 5. Patients with deep vein thrombosis or pulmonary embolism within last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| PK/PD profile | 28 days |
| Immunogenicity | 28 days |
| Anti-tumor activity | 28 days |
| Correlative biomarkers | 28 days |
Countries
Canada, United States
Outcome results
None listed