Cancer
Conditions
Brief summary
This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in combination with erlotinib or cetuximab administered to patients with certain types of cancer.
Interventions
DRUGREGN1400
DRUGErlotinib
DRUGCetuximab
Sponsors
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
include, but are not limited to, the following: 1. Confirmed diagnosis of certain unresectable or metastatic cancers 2. Adequate Eastern Cooperative Oncology Group (ECOG) performance status 3. Adequate hepatic, renal and bone marrow function 4. Resolution of toxicity from prior therapy to grade less than/ = to 1
Exclusion criteria
include, but are not limited to, the following: 1. Active brain metastases 2. Thromboembolic events \< 6 months prior to study 3. Patients with a recent history (within 5 years) of another malignancy. 4. Investigational or any antitumor treatment with a maximum of 4 half-lives or administered 30 days prior to the initial administration of REGN1400 5. Patients who are pregnant or nursing 6. Prior treatment with ErbB3 inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab | Day 1 - Day 28 | Safety will be assessed through analysis of laboratory data, physical examination findings and vital signs according to the schedule of assessments, in addition to the spontaneous reporting of adverse events according to CTCAE version 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) | Day 1 to Day 28 | Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab |
Countries
United States
Outcome results
None listed