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

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

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

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

5. Patients with deep vein thrombosis or pulmonary embolism within last 6 months

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Clinical Trial Management

Investigator Role:

Study Director

Investigator Affiliation:

Regeneron Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

February 2014

Related Keywords:

  • Solid Tumors



Fountain Valley, California  92708
Austin, Texas  78705