Study of Nesvacumab (REGN910/ SAR307746)

June 12, 2015 updated by: Regeneron Pharmaceuticals

A Phase 1 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
  • United States
    • California
      • San Francisco, California, United States
    • Texas
      • San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Dose 1
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Cohort 2
Dose 2
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Cohort 3
Dose 3
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Cohort 4
Dose 4
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Cohort 5
Dose 5
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Expansion Cohort 1
Dose 4
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Expansion Cohort 2
Dose 5
Drug: nesvacumab (REGN910/ SAR307746)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
PK/PD profile
Time Frame: 28 days
28 days
Immunogenicity
Time Frame: 28 days
28 days
Anti-tumor activity
Time Frame: 28 days
28 days
Correlative biomarkers
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 12, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • R910-ST-1010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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