Clinical trial NCT02482441 (phase 1, status: completed)
Conditions: advanced relapsed tumors, refractory solid tumors
ICD codes: D46.4, D46.1, D46.A, D46.0, D46.20, D46.21, D46.22
Drugs: omp-131r10, folfiri
SMILES: FC1=CNC(=O)NC1=O
Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all of the following criteria to be eligible for the study:

          1. Phase 1a portion: Histologically confirmed advanced relapsed or refractory solid
             tumors that have exhausted standard of care therapy or either refuse or are not
             considered to be candidates for any remaining standard therapy.

          2. Age ≥18 years

          3. ECOG performance status 0 or 1 (see Appendix B)

          4. Must have evaluable disease per RECIST 1.1. (see Appendix C)

          5. Subjects must have Formalin-Fixed, Paraffin-Embedded (FFPE) tissue available either
             archived or fresh core or punch needle biopsied at study entry (two fresh
             cores/punches preferred whenever possible).

          6. Must have received their last anti-cancer therapy, including radiotherapy,
             chemotherapy, biologic therapy, or herbal therapy at least 3 weeks or 5 half-lives
             (for systemic agents), whichever is shorter, from initiation of study treatment.

          7. Platelets >100,000/mL without transfusions in the past 7 days

          8. Total bilirubin within 1.5x institutional upper limit of normal (ULN)

               -  AST (SGOT) and ALT (SGPT) <3 X institutional ULN

               -  Patients with documented liver metastases: AST (SGOT) and/or ALT (SGPT) ≤ 5 × ULN

               -  Albumin ≥ 3.0 g/dL

               -  Creatinine <1.5 X institutional ULN OR

               -  Creatinine clearance >50 mL/min/1.73 m2 for subjects with creatinine levels above
                  institutional normal

        Exclusion Criteria:

        Subjects who meet any of the following criteria will not be eligible for participation in
        the study:

          1. Currently receiving any therapeutic treatment for their malignancy including other
             investigational agents

          2. Uncontrolled seizure disorder, active neurologic disease, or active CNS involvement
             except for individuals who have previously treated CNS metastases, are asymptomatic,
             and have no requirement for a corticosteroid dose (indicated to reduce brain edema)
             that is equivalent to a prednisone dose of >10mg orally per day or anti-seizure
             medication for at least 4 weeks prior to first dose of study drug.

          3. History of a Grade 3 or 4 allergic reaction attributed to humanized or human
             monoclonal antibody therapy

          4. Significant intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          5. Pregnant women or nursing women

          6. Subjects with congestive heart failure with New York Heart Association Classification
             III, or IV (see Appendix D)

          7. Known clinically significant gastrointestinal disease including, but not limited to,
             inflammatory bowel disease