This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Dose level 1
Dose level 2
Dose level 3
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Oklahoma City, Oklahoma, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) administered in combination with aflibercept (ziv-aflibercept) in patients with advanced solid malignancies
Time frame: Day 1 to Day 28
Pharmacokinetics (PK)
To assess PK parameters such as concentration of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept).
Time frame: Day 1 to Day 170
Immunogenicity
To assess the anti-drug antibodies of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept)
Time frame: Day 1 to Day 170
Antitumor activity
Objective tumor response according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1
Time frame: Day 1 to Day 170
Pharmacodynamics (PD)
Target inhibition biomarker changes, serum tumor markers
Time frame: Day 1 to Day 170
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dose level 1
Dose level 2
Unnamed facility
San Antonio, Texas, United States
Unnamed facility
Toronto, Canada