A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors

Inclusion Criteria

• •1. Pathologically confirmed: Non-small cell lung cancer (NSCLC, adenocarcinoma or squamous-cell carcinoma), Breast Cancer (HER2 positive or triple negative), Pancreatic Cancer (adenocarcinoma)
• •2. Relapsed or refractory disease (Stage III or IV): NSCLC or pancreatic cancer must have failed at least 1 prior treatment. Breast cancer must have failed at least 2 prior treatments.
• •3. Measurable lesion by RECIST 1.1
• •4. Adequate hematologic function:
• •* ANC \>1500 cells/mm3
• •* Platelet count \>100,000 cells/mm3
• •* HGB \>9.0 g/dL
• •5. Adequate hepatic and renal function:
• •* AST and ALT ≤2.5 x ULN for subjects without liver metastases and ≤3.5 x ULN for subjects with liver metastases
• •* Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
• •* Creatinine ≤2.0 x ULN and Creatinine Clearance ≥40 mL/min (Cockcroft-Gault or 24-hour creatinine clearance collection)
• •6. PT/INR \<1.5 x ULN and PTT/ aPTT \<1.5 x ULN