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OpenTrials
Completed

NCT Number: NCT01271972

Study of Nesvacumab (REGN910/ SAR307746)

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

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

nesvacumab (REGN910/ SAR307746)

Drug

Primary outcomes

  1. Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies

    Time frame: 28 days

Secondary outcomes

  1. PK/PD profile

    Time frame: 28 days

  2. Immunogenicity

    Time frame: 28 days

  3. Anti-tumor activity

    Time frame: 28 days

  4. Correlative biomarkers

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jan 7, 2011
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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