Solid Tumors
Conditions
Brief summary
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept (ziv-aflibercept in the U.S.)
Interventions
Dose level 1
DRUGaflibercept (ziv-aflibercept)
Dose level 1
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria include, but are not limited to, the following: 1. Confirmed diagnosis of solid tumor malignancy 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 3. Adequate hepatic, renal and bone marrow function 4. Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) | Day 1 to Day 28 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) | Day 1 to Day 170 | To assess PK parameters such as concentration of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept). |
| Immunogenicity | Day 1 to Day 170 | To assess the anti-drug antibodies of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept) |
| Antitumor activity | Day 1 to Day 170 | Objective tumor response according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 |
| Pharmacodynamics (PD) | Day 1 to Day 170 | Target inhibition biomarker changes, serum tumor markers |
Countries
Canada, United States
Outcome results
None listed