- Diagnosis of solid tumor that is advanced/metastatic and resistant to standard
therapy or for whom no standard therapy is available.
- Performance Status of 0 or 1. - Adequate bone marrow, kidney, and liver function.
- Part 2 includes ovarian cancer, target expressing triple negative breast cancer and
non small cell lung cancer patients.
- OVCA pts must have progressed while receiving or within 6mos after completion of at
least 4 cycles of platinum-containing regimen. Prior line of therapy up to 3
- OVCA pts excluded with any of the following: non-epithelial, inlcuding malignant
mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only
disease, unresolved bowel obstruction, including sub-occlusive disease, related to
underlying disdease and history of abdominal fistula, GI perforation or
- Brain metastases requiring steroids
- Drug-drug interaction includes advanced metastatic breast cancer, ovarian cancer, or
non small cell lung cancer patients
- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
study treatment start
- Active and clinically significant bacterial, fungal, or viral infection