Study of Nesvacumab (REGN910/ SAR307746)
A Phase 1 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies
1 other identifier
interventional
53
2 countries
3
Brief Summary
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2011
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 5, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 16, 2015
June 1, 2015
3.7 years
January 5, 2011
June 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies
28 days
Secondary Outcomes (4)
PK/PD profile
28 days
Immunogenicity
28 days
Anti-tumor activity
28 days
Correlative biomarkers
28 days
Study Arms (7)
Cohort 1
EXPERIMENTALDose 1
Cohort 2
EXPERIMENTALDose 2
Cohort 3
EXPERIMENTALDose 3
Cohort 4
EXPERIMENTALDose 4
Cohort 5
EXPERIMENTALDose 5
Expansion Cohort 1
EXPERIMENTALDose 4
Expansion Cohort 2
EXPERIMENTALDose 5
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of advanced solid malignancy.
- ECOG performance status 0 - 1
- Adequate hepatic, renal and bone marrow function
- At least 3 weeks since last dose of chemotherapy, hormonal therapy or radiotherapy
- At least 6 weeks since last dose of bevacizumab
- At least 4 weeks since last surgery
- At least 4 weeks since last dose of investigational treatment
You may not qualify if:
- Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
- Patients with serious non healing wound or acute ulcer
- Either systolic blood pressure \>150 mm Hg or diastolic blood pressure \>95 mm Hg
- Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
- Patients with deep vein thrombosis or pulmonary embolism within last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (3)
Unknown Facility
San Francisco, California, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Toronto, Ontario, Canada
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2011
First Posted
January 7, 2011
Study Start
January 1, 2011
Primary Completion
September 1, 2014
Study Completion
May 1, 2015
Last Updated
June 16, 2015
Record last verified: 2015-06