Study of Nesvacumab (REGN910/ SAR307746)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: nesvacumab (REGN910/ SAR307746)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01271972

R910-ST-1010

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

53 participants in 7 patient groups

Cohort 1

Experimental group

Description:

Dose 1

Treatment:

Drug: nesvacumab (REGN910/ SAR307746)

Cohort 2

Experimental group

Description:

Dose 2

Treatment:

Drug: nesvacumab (REGN910/ SAR307746)

Cohort 3

Experimental group

Description:

Dose 3

Treatment:

Drug: nesvacumab (REGN910/ SAR307746)

Cohort 4

Experimental group

Description:

Dose 4

Treatment:

Drug: nesvacumab (REGN910/ SAR307746)

Cohort 5

Experimental group

Description:

Dose 5

Treatment:

Drug: nesvacumab (REGN910/ SAR307746)

Expansion Cohort 1

Experimental group

Description:

Dose 4

Treatment:

Drug: nesvacumab (REGN910/ SAR307746)

Expansion Cohort 2

Experimental group

Description:

Dose 5

Treatment:

Drug: nesvacumab (REGN910/ SAR307746)