A Phase 1b Study of Combined Angiogenesis Inhibition by Administering REGN910 and Aflibercept (Ziv-aflibercept) in Patients With Advanced Solid Malignancies

Inclusion Criteria:

Inclusion criteria include, but are not limited to, the following:

1. Confirmed diagnosis of solid tumor malignancy

2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

3. Adequate hepatic, renal and bone marrow function

4. Resolution of toxicity from prior therapy (except alopecia) to grade less than or
equal to 1

Exclusion Criteria:

Exclusion criteria include, but are not limited to, the following:

1. Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or
other evidence of central nervous system involvement

2. Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg

3. Patients with medical history of myocardial infarction, unstable angina pectoris,
coronary/ peripheral artery bypass graft, congestive heart failure or ventricular
arrhythmia

4. Patients with deep vein thrombosis or pulmonary embolism within last 3 months

5. Patients with serious non healing wound or acute ulcer

6. Patients with treatment resistant or bleeding peptic ulcer disease, erosive
esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious
or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic
event within last 3 months

7. Patients with history of abdominal or tracheal-esophageal fistula

8. Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors

9. Prior treatment with bevacizumab within last 6 weeks

10. Pregnant or breast-feeding women