Ensayos clínicos

Inclusion Criteria:

• Patients ≥ 18 years of age.
• One of the following progressive advanced or metastatic cancers:
  • Epithelial ovarian, fallopian tube, or primary peritoneal cancer (Part 1 and Part 2, Group 1 only) that is platinum refractory or platinum resistant;
  • Pancreatic adenocarcinoma (Part 2, Group 2 only) that is locally advanced, and now with progressive disease on or after front-line treatment;
  • Malignant mesothelioma with epithelioid histology, pleural or primary peritoneal (Part 2, Group 3 only) that is progressive disease following frontline platinum-based chemotherapy;
  • For Part 2 only - Measurable disease according to RECIST v1.1 for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, pancreatic adenocarcinoma, and peritoneal mesothelioma, and mRECIST v1.1 for patients with pleural mesothelioma;
  • Available archival tissue sample or fresh biopsy tissue sample must be obtained prior to enrollment;
  • For patients previously treated with systemic chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent, discontinuation must have occurred ≥ 2 weeks, or at least 5 half-lives, whichever is longer, prior to start of study drug. The maximum washout period will not exceed 4 weeks;
  • ECOG performance status of 0 or 1;
  • Adequate bone marrow function, including:
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3 or ≥ 1.5 x 10^9/L;
    • Platelets ≥ 100,000/mm3 or ≥ 100 x 10^9/L;
    • Hemoglobin (Hgb) ≥ 0 g/dL.
  • Adequate renal function, including estimated creatinine clearance ≥ 50 mL/min;
  • Adequate liver function, including:
    • Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) unless the patient has documented Gilbert syndrome in which case the maximum total serum bilirubin should be < 5 mg/dL;
    • Aspartate and alanine transaminase (AST and ALT) ≤ 2.5 x ULN or AST/ALT ≤ 5 x ULN for patients with liver metastases.
  • Serum albumin ≥ 30 mg/mL.

Exclusion Criteria:

• Previously treated or current brain metastases.
  • Note: Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry and have no evidence of new or enlarging brain metastases.
• Concurrent treatment with anti- TNFα therapies, systemic corticosteroids, or other immune suppressive drugs within the 2 weeks prior to Screening.
• History of or known or suspected autoimmune disease.
• History of clinically significant cardiovascular disease.
• Second primary malignancy that has not been in remission for greater than 3 years.
• Pulmonary, hematologic, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements