- Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy.
Dose Finding Cohorts: Tumor types will be limited to CRC, SCCHN, squamous NSCLC,
bladder, or ovarian carcinomas which have progressed on standard therapy, or for which
no standard therapy is available.
- Measurable disease by RECIST version 1.1.
- For Expansion Cohorts only: patients must have tumor accessible for biopsies (core
needle biopsy or excision preferred).
- Age 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone marrow, renal and liver function.
- Serum/urine pregnancy test (for females of childbearing potential) negative at
screening and before the patient will receive the study treatment.
- Male and female patients of childbearing potential and at risk for pregnancy must
agree to use two (2) highly effective methods of contraception throughout the study
and for 60 days after the last dose of assigned study treatment.
- Active central nervous system primary or secondary malignancies, active seizure
disorder, spinal cord compression, or carcinomatous meningitis.
- Therapeutic or experimental monoclonal antibodies in last 60 days prior registration.
- Systemic anticancer therapy or major surgery within 28 days prior to registration. In
absence of toxicity from prior systemic anticancer therapy, 5 half-lives since
completion of prior systemic anticancer therapy is allowed.
- Systemic steroids, any other form of immunosuppressive therapy or radiation therapy
within 14 days prior to registration.
- Live vaccine within 30 days prior to registration.
- Severe hypersensitivity reaction to treatment with another monoclonal antibody, known
or suspected hypersensitivity to study drugs or any component of their formulation.
- History of autoimmune disease or known inflammatory bowel disease.
- Uncontrolled hypertension (blood pressure >150/100 mmHg despite optimal medical
therapy) or any of the following within 12 months prior to registration: myocardial
infarction, congenital long QT syndrome, torsade de points, arrhythmias, right bundle
branch block and left anterior hemiblock uncontrolled angina, coronary/peripheral
artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or
transient ischemic attack, pulmonary embolism, ongoing NCICTCAE Grade 2 cardiac
dysrhythmias, atrial fibrillation or QTcF interval >470 msec.