Study of Nesvacumab (REGN910/ SAR307746)

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: nesvacumab (REGN910/ SAR307746)

• Registration Number: NCT01271972
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2014-09
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-12
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 4	nesvacumab (REGN910/ SAR307746)	Dose 4
Cohort 5	nesvacumab (REGN910/ SAR307746)	Dose 5
Cohort 2	nesvacumab (REGN910/ SAR307746)	Dose 2
Cohort 3	nesvacumab (REGN910/ SAR307746)	Dose 3
Expansion Cohort 2	nesvacumab (REGN910/ SAR307746)	Dose 5
Cohort 1	nesvacumab (REGN910/ SAR307746)	Dose 1
Expansion Cohort 1	nesvacumab (REGN910/ SAR307746)	Dose 4

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies	28 days

Secondary Outcome Measures

Name	Time	Method
PK/PD profile	28 days
Immunogenicity	28 days
Correlative biomarkers	28 days
Anti-tumor activity	28 days