- Diagnosis - Dose Escalation Phase: Histologically or cytologically confirmed diagnosis
of advanced solid tumor that is resistant to standard therapy or for which no standard
therapy is available.
- Diagnosis - Dose Expansion Phase: Histologically or cytologically confirmed advanced
RCC with a component of clear cell subtype
- Dose Expansion Phase: at least one measureable lesion as defined by RECIST [Response
Evaluation Criterion in Solid Tumors] version 1.1.
- ECOG [Eastern Cooperative Oncology Group] Performance Status 0 or 1.
- Major surgery
- History of or known active seizure disorder, brain metastases, spinal cord
compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal
disease.
- Dose Expansion Phase only: diagnosis of any other malignancy within 2 years prior to
registration.